SCIENTIFIC PAPERS OF THE INDIA FERTILITY RESEARCH PROGRAMME
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SCIENTIFIC PAPERS OF THE
INDIA FERTILITY RESEARCH PROGRAMME - extracted text
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SCIENTIFIC PAPERS OF THE
*
INDIA FERTILITY RESEARCH PROGRAMME
■
■
r ; v.' .
THE INDIA FERTILITY RESEARCH PROGRAMME
1980
■>
*
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PREFACE
This volume contains scientific papers reporting results of recent research studies
of the India Fertility Research Programme (India FRP). Since its inception in
1971, the India FRP has regularly organized Annual Contributors’ Conferences to
provide a forum for the scientific exchange of ideas and to afford an opportunity
for its national network of contributors to present their research results which are
subsequently published in Conference Transactions. This year, although a conference
was not organized by the India FRP, the Programme has, through this publication,
continued its tradition of disseminating its research findings.
The India FRP provides its contributors with standardized study protocols, data
collection instruments and computerized feedback of study results for several
study areas including pregnancy termination and menstrual regulation procedures,
male and female sterilisation methods, intrauterine devices, systemic and
conventional contraceptives, maternity care monitoring and primary health care
delivery systems. Thus far, data on about 100,000 cases have been reported for
over 200 research studies. The Programme has pioneered, through multicentric
clinical field trials, very important innovations which have considerably enhanced
the evolution of fertility control technology especially in the areas of menstrual
regulation, pregnancy termination and female sterilisation. This technology now
forms an integral part of the national programme and has found widespread acceptance
in both urban and rural areas. The present work plan of the India FRP focuses on
improving health care in rural areas by: (a) evaluating promising innovations in
fertility regulation especially nonsurgical female sterilisation methods, which are
expected to have an important impact on programmes in the 1980s, (b) establishing
systems for monitoring maternity care at various service levels and (c) implementing
and evaluating service delivery systems which have the potential for widespread,
rapid adoption in remote rural areas.
My thanks are due to the contributors of the India FRP who have conducted the
research studies and have carefully documented their research results. The
Programme, undoubtedly, owes its success to their continuing enthusiasm and interest.
The inspiring leadership of the Chairman, Dr. C.L. Jhaveri and the support of
members of the Executive Committee of the India FRP is acknowledged. I gratefully
acknowledge the guidance, encouragement and support provided by Dr. Elton Kessel,
Executive Secretary of the International Federation for Family Health, for bringing
out this publication and for his untiring efforts to assist the Programme. I also
thank all the staff of the India FRP for their help and cooperation.
Saroj Pachauri
Hyderabad, India
May 1980
W H- /30
'o* \
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CONTENTS
Page
I
1. FEMALE STERILISATION SEQUELAE - A TWO YEAR FOLLOW-UP STUDY
R.V. Bhatt and Saroj Pachauri
1
2. A COMPARISON OF THE TUBAL RING APPLIED VIA LAPAROSCOPY,
MINILAPAROTOMY AND COLPOTOMY IN POSTABORTION CASES
Saroj Pachauri, Armin Jamshedji and Elizabeth John
I
I
I
I
16
3. COMPLICATIONS AND SEQUELAE FOR 17,492 STERILISATION CASES - A
FIVE YEAR STUDY
Sareena Mary George and May Manuel
36
4. EXPERIENCE WITH LOW WATTAGE BIPOLAR CAUTERIZATION OF THE TUBES
FOR FEMALE STERILISATION - A FOLLOW-UP STUDY
R. Merchant
45
5. FEMALE STERILISATION SERVICES IN RURAL INDIA - PROBLEMS AND
SOLUTIONS
R.V. Bhatt, Saroj Pachauri, L.N. Chauhan, K.M. Jariwala,
Anuradha Shirke and Saroj Maru
52
6. QUINACRINE FOR FEMALE STERILISATION
R. Ananthakrishnan and Usha Krishna
67
7. FACTORS INFLUENCING A WOMAN’S DECISION TO UNDERGO STERILISATION A CAMP STUDY
R.V. Bhatt and Armin Jamshedji
70
8. LAPAROSCOPIC STERILISATION WITH ELECTROCOAGULATION PRIOR TO
PREGNANCY TERMINATION
Padma Rao and S. Basu
84
9. A COMPARISON OF POSTABORTION STERILISATION BY LAPAROSCOPY AND
COLPOTOMY
N.D. Motashaw and Saroj Pachauri
93
10. MATERNITY CARE MONITORING: AN ILLUSTRATION FROM INDIA
Saroj Pachauri and Armin Jamshedji
104
11. MATERNITY CARE MONITORING PROGRAMME OF THE CHRISTIAN MEDICAL
ASSOCIATION OF INDIA - EARLY EXPERIENCE OF ONE HOSPITAL
H.M. Sharma and Shanti Lail
123
12. MATERNITY CARE MONITORING: A COMPARISON OF NINE CENTRES
Saroj Pachauri and Armin Jamshedji
138
13. FERTILITY CONTROL PRACTICES AMONG 15,221 WOMEN UNDERGOING
HOSPITAL DELIVERY
Saroj Pachauri and Armin Jamshedji
166
L
i
r
I
6
l
TABLE II
COMPLAINTS REPORTED FOR WOMEN UNDERGOING STERILISATION IN BARODA, 1973 TO 1979
Complaints
6
N = 770
No.
%
Pelvic pain
Mild
Moderate
Severe
Abdominal pain
Total
Incision related
Mild wound pain
Moderate wound pain
Total
53
9
0
5
67
6.9
1.2
0.0
0.6
8.7
Follow-up Visits (Months)
24
18
12
N = 1798
N = 829
N = 805
No.
%
No.
%
No.
%
35
6
0
3
44
4.3
0.7
0.0
0.4
5.5
27
7
0
4
38
3.3
0.8
0.0
0.5
4.6
55
8
1
7
71
3.1
0.4
0.1
0.4
3.9
2
2
4
0.1
0.1
0.2
0
4
1
0
5
10
0.0
0.2
0.1
0.0
0.3
0.6
I
I
1
I 5
17
10
27
2.2
1.3
3.5
9
1
10
1.1
0.1
1.2
1
0
1
0.1
0.0
0.1
Others
Leucorrhoea
1
3
Weakness/dizziness
Frequent/burning micturition 0
0
Weight gain
0
Psychoneuro sis
Total
4
0.1
0.4
0.0
0.0
0.0
0.5
6
4
0
0
0
10
0.7
0.5
0.0
0.0
0.0
1.2
0
1
1
1
0
3
0.0
0.1
0.1
0.1
0.0
0.4
I
!
i
I
Women with one or more
Complaints
98
12.7
64
7.9
42
5.1
85
4.7
Menstrual Pattern Changes
I
1
The vast majority (90.0%) of the women reported no change in menstrual cycle regularity.
The percentage of women who reported that their menstrual cycles had changed from regular
to irregular (an unfavourable change),,was 2.8, 1.6, 3.1 and 3.1 at the 6, 12, 18 and 24
months follow-up visits respectively. A change from irregular to regular menstrual cycles
was reported by 1.6, 2.9, 3.1 and 1.7 percent women respectively (Fig 3). Until the 18
months follow-up visit, the rates of women reporting an unfavourable change in menstrual
cycle regularity were not significantly different when compared to rates of women
reporting a favourable change and no consistent pattern ofchanges in this parameter was
observed at different time periods. However, at 24 months, the unfavourable change
was significantly more frequent than the favourable change in menstrual cycle regularity
(Fig 3).
Most (84.7% to 88,8%) of the women reported no change in the duration of menstrual flow.
While an increase in the duration of menstrual flow (the unfavourable change in this
parameter), was reported by 7.0, 7.0, 5.2 and 7.8 percent women at the 6, 12, 18 and
24 months follow-up visits respectively,a decrease in the duration of menstrual flew
l
1
7
N=428 ‘
N=489
N=522
N=1122
Regular to
Irregular
2.8%
1.6%
3.1%
3.1%
No Change in
Regularity
95.6%
95.5%
93.8%
95.2%;
1.6%
2.9%
3.1%
1.7%
6
12
18
24
Irregular to
Regular
Follow-up Visits (Months)
Fig 3
CHANGES IN MENSTRUAL CYCLE REGULARITY FOR WOMEN,UNDERGOINGiSTERILISATION
IN BARODA, 1973 TO 1979
was reported by 4.2, 5.7, 6.9 and 7.5 percent women respectively (Fig 4).’ At all time
periods except at 18 months, more women reported an unfavourable change than a favourable
change in this parameter. Until the 18 months follow-up visit, there was no significant
difference in the proportion of women reporting an increase in the duration of menstrual
flow. At 24 months, however, significantly more women reported such increase.
Differences in the rates of women reporting a decrease in the duration of menstrual
flow at different time periods were not statistically significant. At the 6 months
follow-up visit, significantly more women reported an increase as compared to those who
reported a decrease in the duration of menstrual flow (Fig 4).
8
>1 Day Increase
No Change
N=428
N=489
'’ZZZZZZ/
'ZZZZZZZ
'ZZZZZZZ
7.0%
7.0%
5.2%
88.8%
87.3%
87.9%
84.7%
4.2%
5.7%
6.9%
7.5%
6
12
18
24
N=522
N=1122
>1 Day Decrease
Follow-up Visits (Months)
Fig 4
CHANGES IN DURATION OF MENSTRUAL FLOW FOR WOMEN UNDERGOING STERILISATION
IN BARODA, 1973 TO 1979
Most (66.8% to 88.9%) of the women reported no change in the amount of menstrual flow.
At the 6, 12, 18 and 24 months follow-up visits, an increase in the amount of menstrual
flow (an unfavourable change), was reported by 4.9, 3.5, 6.9 and 5.4 percent women and
a decrease by 0.2, 1,2, 3.2 and 4.7 percent women (Fig 5). Between the 18 and 24
months follow-up visits, a significantly lower proportion of women reported an increase
in the amount of menstrual flow. Between the 6, 12 and 18 months follow-up visits
the differences in this parameter were not statistically significant. At all, except
at the 24 months follow-up visit, a significantly higher proportion of women reported
an increase in comparison to those who reported a decrease in the amount of menstrual
flow (Fig 5).
There was a significant decline in the incidence of amenorrhoea at the various follow-up
visits. While 28.2 and 18.2 percent of the women reported amenorrhoea at the 6 and 12
months follow-up visits respectively J the percentage of amenorrhoea cases decreased to 7.9
and 1.1 percent respectively at the 18 and 24 months follow-up visits (Fig 5). The
high incidence of amenorrhoea in the first six months was, probably, due to lactational
amenorrhoea among the postpartum cases.
9
While the majority (82.4% to 87.6%) of the women reported no change in dysmenorrhoea
following sterilisation, an increase in dysmenorrhoea was reported by 5.8, 7.0,
7.~, 6.1
and 4.4 percent and a decrease by 6.5, 9.2, 11.5 and 9.8 percent women respectively
N=608
N=605
Increase
4.9%
No Change
66.8%
Decrease
0.2%
xs\x\xx\
3.5%
wwww
77.1%
N=1146
N=576
6.9%
^SXXXXXX
k\XXXXXX
t\\\\XXX
5.4%
88.9%
82.0%
1.2%
3.2%
Amenorrhoea
28.2%
18.2%
6
4.7%
1.1%
7.9%
12
18
24
Follow-up Visits (Months)
Fig 5
CHANGE IN AMOUNT OF MENSTRUAL FLOW FOR WOMEN UNDERGOING STERILISATION
IN BARODA, 1973 TO 1979
at the 6, 12, 18 and 24 months follow-up visits, It is interesting to note that at
each time period, more women reported a decrease as compared to those who reported
an increase in dysmenorrhoea (Fig
QFlg 6).
bj. However, the differences were statistically
significant only at the 18 and 24 months follow-up visits.
10
N=428
Increase
No Change
XX XXXXX5
N=489
xxxxxxv
N=522
N=U22
XXX\XXX>
TxTTxTTx
xxxxxxx\
5.8%
7.0%
6.1%
4.4%
87.6%
83.8%
82.4%
85.8%
9.2%
11.5%
9.8%
WSSwi
Decrease
6
12
18
24
Follow-up Visits (Months)
Fig 6
CHANGES IN SEVERITY OF DYSMENORRHOEA FOR WOMEN UNDERGOING STERILISATION
IN BARODA, 1973 TO 1979
JI
11
3.0
2.6
Dilatation & Curettage
|^| Hysterectomy
Other
acu
eo
■
□ All surgery
■U
1.3
o
1.1
^7^
////>
a<u
(D
Pm
KO
/z///
z///>
z/zz.
/ zzz >
''////.
Y///
0.1
0
0,2
0.2
12
24
Months
Months
Fig 7
■
CUMULATIVE RATES OF GYNAECOLOGICAL SURGERY REPORTED FOR WOMEN UNDERGOING
STERILISATION IN BARODA, 1973 TO 1979
■
TABLE III
■
GYNAECOLOGICAL SURGERY PERFORMED SUBSEQUENT TO STERILISATION IN BARODA,,
1973 TO 1979
■
6
Gynaecological Surgery
N=77O
No.
%
■
I
■
Months Following Sterilisation
12
18
Dilatation and curettage
Hysterectomy
Repair of prolapse
Repair of incisional hernia
Tubal reanastamosis
TOTAL
N=805
No.
%
N=829
No.
%
24
N=1798
No.
%
1
0
0
0
0
0.1
0.0
0.0
0.0
0.0
5
1
0
1
1
0.6
0.1
0.0
0.1
0.1
13
2
1
0
0
1.6
0.2
0.1
0.0
0.0
5
16
0
1
1
0.3
0.9
0.0
0.1
0.1
1
0.1
8
1.0
16
1.9
23
1.3
ti
I
I-
16
A COMPARISON OF THE TUBAL RING APPLIED VIA LAPAROSCOPY,
MINILAPAROTOMY AND COLPOTOMY IN POSTABORTION CASES
Saroj Pachauri, MD3 DPH3 PhD'1' Armin Jcanshedji, MA
Elizabeifa John, MSc'2
9
■
ABSTRACT
This is an analysis of 692 laparoscopy, 149 minilaparotomy and 264 colpototiiy
postabortion sterilisation procedures performed with the tubal ring technique. The
data are drawn from comparative, randomized studies conducted by the India Fertility
Research Programme (India FRP) to evaluate the safety and effectiveness of these
procedures.
Surgical and operating room time were significantly lower for laparoscopy than for
minilaparotomy and colpotomy. All the women undergoing colpotomy were hospitalised;
55.3 and 30.9 percent of those undergoing laparoscopy and minilaparotomy respectively
were sterilised on an outpatient basis. Although the planned procedure was success
fully completed in all cases, alternative techniques for tubal occlusion were employed
for two laparoscopy and four colpotomy procedures. Technical failure rates were not
significantly different for the three sterilisation methods. The incidence of surgical
difficulties was, however, higher for minilaparotomy.
The incidence of operative complications was similar for all three procedures.
Immediate and early postoperative complication rates were significantly higher for
minilaparotomy'because of the high incidence of mostly minor, incision-related
complications. The incidence of complaints (predominantly pelvic pain), was signi
ficantly higher for minilaparotomy in the immediate but not in the early postoperative
period. Although the incidence of gynaecological abnormalities six months after
sterilisation was significantly higher for colpotomy, it was not significantly different
for laparoscopy and minilaparotomy at later follow-up. Only one pregnancy following
laparoscopy was reported in this series. The relative merits and demerits of the
three sterilisation procedures for large-scale programmes in India are discussed.
INTRODUCTION
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■
I
In recent years there has been an increasing demand for female sterilisation in India.
A woman who has completed her desired family size is generally faced with the choice
between twenty;, or more years of fertility regulation by contraception and fertility
termination by sterilisation and she often opts for permanent sterilisation.
■
K wide range of female sterilisation approaches and techniques have been used depending
upon a variety of factors such as availability and cost of equipment as well as safety,
effectiveness and acceptability of methods. Sterilisation has been extensively
n
1 I
^Research Director, ^Research Assistant, India Fertility Research Programme,
Hyderabad.
■
I
17
performed via minilaparotomy, colpototmy and laparoscopy. Minilaparotomy is often
preferred to laparoscopy because it can be performed with simple and inexpensive
instruments and is, therefore, considered more suitable for developing countries.
The colpotomy approach has been extensively used in India as the absence of an
abdominal scar makes this method highly acceptable to the Indian woman (1,2). While
laparoscopy is a highly acceptable method of female sterilisation, the expensive
sophisticated equipment and potentially serious hazards associated with electrocoagulati
have limited its application. Mechanical occlusive techniques have been developed
to eliminate these hazards. A variety of clips were tried and abandoned because of
the unacceptable failure rates associated with them (3-8). The tubal ring technique
is gaining popularity and has been used via laparoscopy (9-13), minilaparotomy (12—15)
and colpotomy (16,17).
Well controlled, random, comparative studies are needed to scientifically evaluate
and compare the safety and effectiveness of different approaches to the Fallopian
tubes and different techniques for occluding them. This report evaluates the short
and long-term safety and effectiveness of the tubal ring technique applied via
The
laparoscopy, minilaparotomy and colpotomy in postabortion cases. Tl
—evaluation
-------- —is
based on comparative studies conducted by the India FRP.
MATERIALS AND METHODS
Data on 692 laparoscopy, 149 minilaparotomy and 264 colpotomy procedures are reported.
The standard protocol of the India FRP was used for all studies, Clinical events
within 21 days were reported for all study cases. Long-term follow-up data were
reported for 540 cases at six.months, for 288 cases at twelve months, for 187 cases
at eighteen months and 97 cases at 24 months poststerilisation. For colpotomy cases,
follow-up data were reported for the six months visit only.
Study Methodology
Data from five comparative studies of the India FRP are reported in this paper.
In all study cases, the tubal ring was used to occlude the Fallopian tubes and sterili
sation was performed immediately after first trimester pregnancy termination by vacuum
aspiration.* The female sterilisation approach was randomly allocated in all studies.
To eliminate inter-operator variability, in each study a single operator performed all
the surgical procedures and recorded data related to procedures and events which
occurred while the patient was in the operating room. To evaluate evaluator bias,
a second physician (the evaluator) was responsible for the care of the patient after
her discharge from the operating room, The evaluator also provided follow-up care and
recorded data on all postoperative events from the time of discharge from the operating
room to the time of the early and long-term follow-up visits.
Premedication and Anaesthesia
The study subject received 0.6 mg of atropine intramuscularly about half an hour
before surgery. When local anaesthetics were used, premedication, generally in the
form of diazepam with pethidine, was administered intravenously about 15 minutes before
18
surgery. Most of the laparoscopic sterilisations were performed with local anaesthesia
(67.9%); 15 to 20 ml of 1 percent lidocaine was infilterated at the operation site.
General anaesthesia was administered to 20.5 percent and regional anaesthesia to 11.6
percent women undergoing laparoscopy. . While all the minilaparotomy procedures were
performed with local anaesthesia, only 6.8 percent of the colpotomy procedures were
performed with local anaesthesia^ General anaesthesia was used for 56.8 percent and
regional anaesthesia for 36.4 percent of the colpotomy procedures.
Surgical Technique
For laparoscopic sterilisation, atmospheric air or carbon dioxide was used to create
pneumoperitoneum. Sterilisation was performed using the standard surgical technique.
The tubal ring was applied to the tube at a distance of 3 to 4 cm from its cornual end.
The tubes were occluded through a second incision in 21.8 percent cases. The skin
incision was closed using either a single catgut stitch or a tineture-benzoin seal.
For minilaparotomy, the patient was placed in the Trendlenburg position and the
Vitton’s manipulator was introduced into the uterus. A 4 cm incision was made two
fingers above the symphasis pubis. After opening the peritoneum, the uterus was
manipulated to bring the Fallopian tube into view. The tube was gently caught with
the Babcock’s forceps and the tubal ring applied 4 cm from its cornual end. This
procedure was repeated on the other side. The peritoneum was closed by continuous
catgut sutures and the skin by subcuticular catgut.
Colpotomy was performed through an incision in the posterior fornix. The tubal ring
was applied using the tubal ring applicator. The vaginal wall and peritoneum were
closed together with chromic catgut sutures.
Subject Selection, Definitions and Criteria
Only women who underwent sterilisation for family size limitation were included in
the study.
Surgical time was defined as the time from the commencement of dilatation to final
closure. Operating room time was the time from entering to leaving the operating
room and included surgical time.
Complications and complaints due to the sterilisation procedure were categorised as
operative, immediate, early and delayed postoperative. Operative complications and
complaints were those occurring during surgery. Immediate postoperative complications
and complaints were those occurring after surgery but prior to the patient’s discharge
from the hospital. Early postoperative complications and complaints were those reported
between discharge and the first follow-up visit 7 to 21 days after sterilisation.
(For patients who were hospitalised for 7 or more nights, this category of complications
were reported during hospitalisation). Delayed postoperative complications and
complaints were those reported at the follow-up visits at six, twelve, eighteen and
twenty four months and included all gynaecological abnormalities detected and
complaints reported at these visits.
All statistical tests were performed using a significance level (p value) of 0.05.
19
RESULTS
Sociodemographic Characteristics
Sociodemographic characteristics including age, parity and education were similar for
women undergoing laparoscopy, minilaparotomy and colpotomy (Table I).
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 1,105 WOMEN UNDERGOING LAPAROSCOPY, MINILAPAROTOMY
AND COLPOTOMY IN INDIA, 1975 TO 1979
Sociodemographic
Characteristics
Laparoscopy
N=692
No.
7.
Age (Years)
20 - 24
25 - 29
30 - 34
35 - 39
40 +
Mean
40
224
247
144
37
Parity
0
1 - 2
3-4
5-6
7 +
Mean
1
149
402
121
19
Education
(School years)
0
1-3
4-6
7-9
10 - 12
13 +
Mean
5.8
32.4
35.7
20.8
5.3
Minilaparo tomy
N=149
No.
%
0.1
21.5
58.1
17.5
2.7
29.2
5.6
22.5
18.9
3.7
19 ?8
3.9
28.2
4.0
24.2
17.4
22.1
4.0
42
6
36
26
33
6
5.8
0.4
15.1
61.4
18.6
4.5
1
40
162
49
12
3.7
3.5
5.6
32.3
0.0
14.8
58.4
26.8
0.0
0
22
87
40
0
4.5
26.1
35.6
25.8
7.9
12
69
94
68
21
29.8
31.4
202
39
156
131
. 137
27
8.7
36.2
46.3
8.7
0.0
13
54
69
13
0
Colpotomy
N=264
No.
%
40.1
8.3
19.7
17.8
12.1
1.9
1Q6
22
52
47
32
5
4.4
Surgical Time and Hospitalisation
Mean surgical time was significantly lower when sterilisation was performed via
laparoscopy (10.4 minutes) than when it was performed via minilaparotomy (18.7 minutes)
and colpotomy (15,2 minutes) (Table II and Fig 1). While 95.6 percent of the laparosco
procedures were completed within 20 minutes, 67.1 percent and 87.2 percent of the
minilaparotomy and colpotomy procedures respectively were completed within this time.
20
TABLE II
SURGICAL AWOPERATING ROOM TIME FOR 1,105 WOMEN UNDERGOING LAPAROSCOPY, MINILAPAROTOMY
AND COLPOTOMY IN INDIA, 1975 TO 1979
Minilaparotomy
N=149
%
No.
Laparoscopy
N=692
No.
%
Time (Minutes)
Surgical Time
<
5
6 - 10
11 - 15
16 - 20
21 - 25
26 +
Mean
13.4
44.2
28.0
10.0
3.3
1.0
93
306
194
69
23
7
0.0
2.0
25.5
39.6
21.5
11.4
0
3
38
59
32
17
Colpotomy
N=264
No.
%
0.8
22.7
27.3
36.4
7.2
5.7
2
60
72
96
19
15
10.4
18.7
15.2
28.8
46.2
31.8
Operating Room Time
Mean
Laparoscopy
gU Minilaparotomy
UH Colpotomy
50.0.
46.2
M
0)
Cfi
unJ
31.8
4->
a<u
2;
(D
18.7
10.4
Operating Room
Time
Surgical
Time
Fig 1
SURGICAL AND OPERATING ROOM TIME FOR 1,105
WOMEN UNDERGOING LAPAROSCOPY,
MTMTTAPAPATOMY AND COTPOTOMV
21
The average time spent in the operating room was also lower for women who underwent
laparoscopy (28,8 minutes) than for those who underwent minilaparotomy (46.2 minutes)
and colpotomy (31.8 minutes) (Table II and Fig I), While all the women who underwent
colpotomy were hospitalised, 55.3 and 30.9^percent of those who underwent laparoscopy
sterilised on an outpatient basis.
and minilaparotomy respectively were Ltcrilizc-
Technical Failures
-, The tubal ring
There were two (0.3%) technical failures among the laparoscopy- cases,
carbon
dioxide
had leaked
could not be applied on the right side in one patient as
_
out through the spoilt rubber gasket and the operator had difficulty reaching t e
Fallopian tube. The right tube was, therefore, occluded by electrocoagulation, and the
left tube with the tubal ring. In the second case, the tubal ring could not be
applied because the Fallopian tubes were thick and so could not be pulled into the
ring applicator. The right tube got cut while applying the ring and so a clip was
applied on either side of the knuckle to go across the tube and onto the mesosalpinx.
The tubal ring technique was not attempted on the left side as the left tube was
thickened at the cornual end; two clips were applied to occlude it.
No technical failures were reported among the minilaparotomy cases. Four (I.5%)
technical failures were reported among the colpotomy procedures. In all four cases
sterilisation was successfully performed via colpotomy. However, the technique used
for tubal occlusion was different from the planned tubal ring technique. In one case,
the tubal ring was applied successfully to the right tube but the left tube was ligated
by the Madleiner’s technique because the mesosalpinx and the tubal wall were torn by
the grasping forceps. In another case, the right tube was successfully occlude
with the tubal ring but as the left tube was adherent and could not be visualised,
it was ligated by the Pomeroy technique and a part of it was sectioned. In two cases,
the tubal ring technique was used successfully to occlude one tube. However, the
other tube could not be brought into the operation field owing to the presence o
adhesions and so it was sectioned and tied.
Technical and Surgical Difficulties
l-i
The incidence of technical difficulties
was5 higher for laparoscopy (1.9%) than for
No
technical
difficulties
were reported for minilaparotomy (Table
colpotomy (0.8%).
The
differences
in
the
rates
of technical difficulties were not
Ill and Fig 2).
statistically significant.
The
incidence of
of surgical
surgical difficulties
difficulties was highest for, minilaparotomy (6.0%) and
The incidence
1
~
, me rate
lowest for colpotomy (I.9%); this difference was statistically
significant.
(Table III and Fig 2).
of surgical difficulties was L3.8 percent for laparoscopy
.
_2
’
. While omentun
Adhesions were a cause of surgical difficulty with all three
approaches,
surgical
difficulty
for
laparoscopy
(l.0%)
interference was the mpst common cause of
the
most
frequent
problem
for
minilaparotomy
difficulty in exteriorizing the tubes was
(4.0%) and colpotomy (0.8%) (Table III).
Laparoscopy
^11 Minilaparo tomy.
Colpotomy
j
w
0)
od
CN
10.0
4-»
C
(D
u
6.0
0)
p-<
5.0
3.8
1.9
1.9
0
■ 0.8
j WK
Techincal
Surgical
Difficulties
Fig 2
TECHNICAL AND SURGICAL DIFFICULTIES REPORTED FOR
1,105 WOMEN UNDERGOING LAPAROSCOPY, MINILAPA
ROTOMY AND COLPOTOMY IN INDIA, 1975 TO 1979
23
TABLE III
TECHNICAL AND SURGICAL DIFFICULTIES REPORTED FOR 1,105 WOMEN UNDERGOING LAPAROSCOPY,
MINILAPAROTOMY AND COLPOTOMY IN INDIA, 1975 TO 1979
Difficulties
Laparoscopy
N-692
No.
%
Technical:
Gas leakage through
rubber gasket
6
Improper ring application 6
2
Applicator problems
1
Needle broke
1
Ring broke
0
Poor light source
Total 13
Surgical:
Omentum interference
Difficulty in
exteriorizing tubes
Thick/tortous tubes
Adhesions
Difficulty in creating
pnuemoperitoneum
Difficulty in inserting
needle/trocar
Cystic ovary
Enlarged uterus
Total
Minilaparo tomy
N=149
No.
%
Colpotomy
N=264
No.
%
0.9
0.9
0.3
0.1
0.1
0.0
1.9
0
0
0
0
0
0
0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0
0
1
0
0
1
2
0.0
0.0
0.4
0.0
0.0
0.4
0.8
7
1.0
0
0.0
0
0.0
0
6
6
0.0
0.9
0.9
6
0
3
4.0
0.0
2.0
2
1
2
0.8
0.4
0.8
2
0.3
0
0.0
0
0.0
2
2
1
2.6
0.3
0.3
0.1
3.8
0
0
0
9
0.0
0.0
0.0
6.0
0
0
0
5
0.0
0.0
0.0
1.9
Complications
The incidence of operative complications was not significantly different for women
undergoing laparosoppy (0.7%), minilaparotomy (1.3%) and colpotomy (1,1%) (Table IV
and Fig 3). Bladder injury occurred during one minilaparotpipy procedure; no other
serious operative complicaticms attributable to the sterilisation procedure were
reported (Table IV).
The immediate postoperative complication rate was significantly lower for laparoscopy
(0.7%) than for colpotomy (2.3%) and minilaparotomy (6.7%) (Table IV and Fig 3).
The most common complications for minilaparotomy (5.2%) were incision-related.
Fever (1.9%) was the most frequently reported complication for women sterilised
via colpotomy. One woman undergoing laparoscopy had excessive bleeding requiring
transfusion (Table IV).
34.9
35.0
Colpotomy
W
<D
W
OJ
25.0
U
CN
C
0)
o
(D
Pm
15.0
5.0
Operative
Immediate
Postoperative
EarlyPostoperative
Complications
Fig 3
COMPLICATIONS REPORTED FOR 1,105 WOMEN UNDERGOING LAPAROSCOPY,
MINILAPAROTOMY AND COLPOTOMY IN INDIA, 1975 TO 1979
25
TABLE IV
COMPLICATIONS REPORTED FOR 1,105 WOMEN UNDERGOING LAPAROSCOPY, MINILAPAROTOMY
AND COLPOTOMY IN INDIA, 1975 TO 1979
Laparoscopy
N=692
No.
%
Complications
Operative:
Bladder injury
Avulsion of tube
Partial tear of tube
Knuckle of tube divided
Tear of mesosalpynx
Brochospasm due to
anaesthesia
Total
Immediate postoperative:
Blood loss requiring
transfusion
Haematoma
Vasovagal attack
Fever
Bleeding per vagina
Incision related:
Infection
Gaping wound
Serous discharge
Induration
Total
Early postoperative:
Pelvic infection
Mild salpingitis
Fever
Bleeding
Vaginitis
Incision related:
Mild infection
Sepsis
Gaping wound
Omental herniation from
wound
Serous discharge
Induration
Haematoma
Total
Minilaparo tomy
N=149
No.
%
Colpotomy
N=264
No.
%
0
1
1
1
1
0.0
0.1
0.1
0.1
0.1
1
0
0
0
1
0.7
0.0
0.0
0.0
0.7
0
1
0
0
1
0.0
0.4
0.0
0.0
0.4
1
0.1
0
0.0
1
0.4
5
0.7
2
1.3
3
1.1
1
2
2
0
0
0.1
0.3
0.3
0.0
0.0
0
0
0
2
0
0.0
0.0
0.0
1.3
0.0
0
0
0
5
1
0.0
0.0
0.0
1.9
0.4
0
0
0
0
0.0
0.0
0.0
0.0
2
2
2
2
1.3
1.3
1.3
1.3
0
0
0
0
0.0
0.0
0.0
0.0
5
0.7
10
6.7
6
2.3
1
1
2
1
2
0.1
0.1
0.3
0.1
0.3
2
0
0
0
1
1.3
0.0
0.0
0.0
0.7
0
0
11
1
0
0.0
0.0
4.2
0.4
0.0
6
2
2
0.9
0.3
0.3
9
0
8
6.0
0.0
5.4
0
0
0
0.0
0.0
0.0
1
9
5
0
0.1
1.3
0.7
0.0
0
16
15
1
0.0
10.7
10.1
0.7
0
0
0
0
0.0
0.0
0.0
0.0
32
4.6
52
34.9
12
4.5
In the early postoperative period, the rate of complications for minilaparotomy
(34.9%) was six times higher than that for laparoscopy (4.6%) and colpotomy (4.5%)
(Table IV and Fig 3). The vast majority of the early postoperative complications
reported for women undergoing minilaparotomy were, however, incision-related (32.9%)
and most of these were minor complications including serous discharge (10.7%) and
induration (10.1%). Mild infection and gaping wound were reported for 6.0 and 5.4
percent of these cases respectively. Among the colpotomy cases, fever (4.2%) was
the most commonly reported early postoperative complication. The incidence of
incision-related complications for laparoscopy was 3.6 percent (Table IV).
Complaints
The incidence of complaints in the immediate postoperative period was significantly
higher for minilaparotomy (24.2%) than for laparoscopy (9.7%) and colpotomy (3.4%)
(Table V and Fig 4). The most frequently reported complaint was pelvic pain. The
frequency of pelvic pain was significantly higher for women undergoing minilaparotomy
(18.1%) and was considerably lower for those undergoing laparoscopy (6.8%) and
colpotomy (2.3%) (Table V).
TABLE V
COMPLAINTS REPORTED BY 1,105 WOMEN UNDERGOING LAPAROSCOPY, MINILAPAROTOMY
AND COLPOTOMY IN INDIA, 1975 TO 1979
Complaints
Immediate postoperative:
Pelvic pain
Giddiness/weakness
Vomiting
Abdominal distention
Chest pain
Frequent/burning micturition
Depression
Incision pain
Iodine burns
To tai
Early postoperative:
Pelvic pain
Spotting per vagina
Bleeding per vagina
Abdominal distention
Nausea/vomi ting
Giddiness/weakness
Depression
Frequency of micturition
Incision related:
Induration
Pain
Itching
Total
Laparoscopy
N=692
No.
%
Minilaparo tomy
N=149
No.
%
47
7
7
3
2
1
0
0
0
67
6.8
1.0
1.0
0.4
0.3
0.1
0.0
0.0
0.0
9.7
27
3
1
0
0
0
1
3
1
36
18.1
2.0
0.7
0.0
0.0
0.0
0.7
2.0
0.7
24.2
6
1
1
0
1
1
0
0
0
9
2.3
0.4
0.4
0.0
0.4
0.4
0.0
0.0
0.0
3.4
35
9
0
5
5
2
0
0
5.1
1.3
0.0
0.7
0.7
0.3
0.0
0.0
13
0
0
0
0
0
1
1
8.7
0.0
0.0
0.0
0.0
0.0
0.7
0.7
5
4
5
0
0
1
0
0
1.9
1.5
1.9
0.0
0.0
0.4
0.0
0.0
3
2
1
62
0.4
0.3
0.1
9.0
0
0
1
16
0.0
0.0
0.7
10.7
0
0
0
15
0 .0
0 .0
0 .0
5 .7
Colpotomy
N=264
No.
%
21
Laparoscopy
HI Minilaparotomy
Colpotomy
30.0
24.2
(D
CD
nJ
O
15.0
10.7
■U
9.7 III
<D
O
0)
Ph
3.4
0
11
9.0
5.7
Early
Postoperative
Immediate
Postoperative
Complaints
Fig 4
COMPLAINTS REPORTED FOR 1,105 WOMEN UNDERGOING
LAPAROSCOPY, MINILAPAROTOMY AND COLPOTOMY
IN INDIA, 1975 TO 1979
In the early postoperative period, complaints were reported with similar frequency
by women undergoing laparoscopy (9.0%) and minilaparotomy (10.7%). The incidence of
early postoperative complaints was lower for women undergoing colpotomy (5.7%) (Table
V and Fig 4). While pelvic pain (5.1%) and spotting per vagina (1.3%) were the most
common complaints after laparoscopy, pelvic pain was, by far, the most frequently
reported complaint after minilaparotomy (8.7%) and pelvic pain (1.9%), spotting (1.5%)
and bleeding per vagina (1.9%) were the most frequently reported complaints after
colpotomy (Table V).
Delayed complications and Complaints
While these conditions are reported for all three groups of cases 6 months after
sterilisation, they are reported only for the laparoscopy and minilaparotomy cases
at 12, 18 and 24 months after sterilisation.
28
The incidence of gynaecological abnormalities 6 months after sterilisation was
significantly higher for women who underwent colpotomy (42.2%). Gynaecological
abnormalities were reported more frequently for women who underwent minilaparotomy
(20.7%) than for those who underwent laparoscopy (15.5%) but the difference was not
statistically significant (Table VI and Fig 5). Cervical erosion was the most
frequently reported gynaecological abnormality for all three groups of cases.
Conditions that accounted for the higher rate among colpotomy cases were mainly
cervical erosion, pelvic infection and tubo-ovarian masses (Table VI).
TABLE VI
GYNAECOLOGICAL ABNORMALITIES REPORTED AT 6 MONTHS FOR 540 WOMEN UNDERGOING
LAPAROSCOPY, MINILAPAROTOMY AND COLPOTOMY IN INDIA, 1975 TO 1979
Gynaecological Abnormalities
Cervical erosion
Endocervicitis
Thickened/tender adnexae
Pelvic infection
Salpingitis
Parametritis
Tubo-ovarian masses
Vaginitis
Vaginal cyst
Vulval furuncles
Urinary tract infection
Carcinoma in situ
Leuplakic patch
Dysplasia
Cys tocoele
Rectocoele
Uterine prolapse
Wound sepsis
Keloid
TOTAL
Minilaparo tomy
N=121
No.
%
Laparoscopy
N=310
No.
%
20
3
8
2
1
0
0
3
1
0
2
0
1
1
4
1
1
0
0
6.4
1.0
2.6
0.6
0.3
0.0
0.0
1.0
0.3
0.0
0.6
0.0
0.3
0.3
1.3
0.3
0.3
0,0
0.0
48
15.5
I
Colpotomy
N=109
No.
%
7
2
2
3
0
1
1
1
0
0
1
0
0
0
1
0
1
1
4
5.8
1.6
1.6
2.5
0.0
0.8
0.8
0.8
0.0
0.0
0.8
0.0
0.0
0.0
0.8
0.0
0.8
0.8
3.3
19
3
5
9
0
0
4
0
0
1
0
1
0
0
2
2
0
0
0
17.4
2.7
4.6
8.3
0.0
0.0
3.7
0.0
0.0
0.9
0.0
0.9
0.0
0.0
1.8
1.8
0.0
0.0
0.0
25
20.7
46
42.2
Twelve months after sterilisation, gynaecological abnormalities were reported more
frequently for women who underwent laparoscopy (12.6%) than for those who underwent
minilaparotomy (11.2%) but the difference was not statistically significant (Table VII
and Fig 5). While the incidence of cervical erosion and thickened/tender adnexae
was higher for women who underwent laparoscopy, the incidence of pelvic infection
was higher for those who underwent minilaparotomy (Table VII).
I
29
TABLE VII
GYNAECOLOGICAL ABNORMALITIES REPORTED AT 12, 18 AND 24 MONTHS FOR WOMEN UNDERGOING
LAPAROSCOPY AND MINILAPAROTOMY IN INDIA, 1975 TO 1979
Gynaecological Abnormalities
Laparoscopy
No.
%
Twelve Months:
Thickened/tender adnexae
Mass in .'fornix
Pelvic infection
Cervical erosion
Vaginitis
Urinary tract infection
Keloid
Total
8
1
2
10
2
1
1
25
Eighteen Months:
Pelvic infection
Thickened/tender adnexae
Cervical erosion
Endocervicitis
Vaginal infection
Uterine prolapse
Cystocoele
Incisional hernia
Total
0
0
5
1
1
0
1
0
8
Minilaparo tomy
No.
%
N=89
N=199
4.0
0.5
1.0
5.0
1.0
0.5
0.5
12.6
1
1
3
2
1
1
1
10
0.0
0.0
5.4
1.1
1.1
0.0
1.1
0.0
8.7
2
3
2
1
0
2
0
1
11
N=95
N=92
Total
0
0
1
1
1
1
4
2.1
3.2
2.1
1.0
0.0
2.1
0.0
1.0
11.6
N=45
N=52
Twenty-four Months:
Pelvic infection
Cervical erosion
Irregular cervix
Tender fornix
Uterine prolapse
Cystocoele
1.1
1.1
3.4
2.2
1.1
1.1
1.1
11.2
0.0
0.0
1.9
1.9
1.9
1.9
7.7
1
1
0
0
1
1
4
2.2
2.2
0.0
0.0
2.2
2.2
8.9
At 18 months, a higher incidence of gynaecological abnormalities was reported for
the minilaparotomy (11,6%) than for the laparoscopy (8.7%) cases but the difference
was not statistically significant (Table VII and Fig 5). The incidence of pelvic
infection (2.1%), uterine prolapse (2.1%) and thickened/tender adnexae (3.2%)
accounted for the higher rate among the minilaparotomy cases (Table VII).
At 24 months also the incidence of gynaecological abnormalities was higher for
women who underwent minilaparotomy (8.9%) than for those who underwent laparoscopy
(7.7%) but the difference was not statistically significant (Table VII and Fig 5).
The higher rate for minilaparotomy was due to the higher incidence of pelvic infection
(2;2%) and cervical erosion (2.2%) among these cases (Table VII).
30
50.0
42.2
25.0
15.5
20
|
12.6
11.2 M
0
6 Months
12 Months
18 Months
24 Months
Fig 5
GYNAECOLOGICAL ABNORMALITIES REPORTED AT LONG TERM FOLLOW-UP
FOR WOMEN UNDERGOING LAPAROSCOPY, MINILAPAROTOMY AND
COLPOTOMY IN INDIA, 1975 TO 1979
Complaints
At 6 months, the incidence of complaints was significantly lower for women who underwent
laparoscopy (7.4%); the frequency of complaints was similar for those who underwent
minilaparotomy (22.3%) and colpotomy (22.0%). Pelvic pain was reported more frequently
by women who underwent colpotomy (22.0%) than for those who underwent minilaparotomy
(13.2%) Mad for those who underwent laparoscopy (5.3%). These differences were statis
tically significant (Table VIII and Fig 6). Wound pain was reported more frequently by
women who underwent minilaparotomy (9.1%) than for those who underwent laparoscopy (1.6%).
30.0
f Laparoscopy
22.0 22.3
co
0)
co
co
u
JU Minilaparotomy
m Colpotomy
15.0 —
c0)
u
(1)
7.4
6 Months
4.4
6.3
5.6
3.5
3.3
3.8
12 Months
18 Months
24 Months
Fig 6
COMPLAINTS REPORTED AT LONG-TERM FOLLOW-UP BY WOMEN
UNDERGOING LAPAROSCOPY, MINILAPAROTOMY AND
31
i
TABLE VIII
COMPLAINTS REPORTED AT LONG-TERM FOLLOW-UP BY WOMEN UNDERGOING LAPAROSCOPY,
MINILAPAROTOMY AND COLPOTOMY IN INDIA, 1975 TO 1979
Laparoscopy
No.
%
Complaints
Six Months:
Pelvic pain
Wound pain
Minilaparo tomy
No.
%
N=121
N=310
Total
18
5
23
Twelve Months:
Pelvic pain
Wound pain
General weakness
Total
5
1
1
7
Eighteen Months:
Pelvic pain
Wound pain
Weight gain
Total
2
0
1
3
Twenty four Months:
Pelvic pain
Total
2
2
Colpotomy
No.
7O
5.8
1.6
7.4
16
11
27
2.5
0.5
0.5
3.5
3
2
0
5
2.2
0.0
1.1
3.3
5
1
0
6
3.8
3.8
2
2
N=109
13.2
9.1
22.3
24
0
24
22.0
0.0
22.0
N=89
N=199
3.4
2.2
0.0
5.6
N=95
N=92
N=52
5.3
1.0
0.0
6.3
N=45
4.4
4.4
Note: Follow-up data after 6 months was not available for women who underwent
colpotomy.
The incidence of complaints decreased markedly after 6 months for women who underwent
minilaparotomy. At 12 months, the incidence of pelvic pain and wound pain was significant
higher for the minilaparotomy than for the laparoscopy cases (Table VIII and Fig 6).
At 18 and 24 months also complaints were reported more frequently by women who underwent
minilaparotomy than those who underwent laparoscopy (Table VIII and Fig 6). However,
these differences were not statistically significant.
Gynaecological Surgery
After laparoscopic sterilisation, dilatation and curettage (D&C) was performed in three
(0.6%) cases; one woman underwent D&C at six months and two women underwent this procedure
at 18 months. After minilaparotomy, D&C was performed in one (1.0%) case 18 months
after sterilisation and hysterectomy in 3 (6.7%) cases 24 months after sterilisation.
Pregnancies
Only one pregnancy was reported in this series, This pregnancy was reported six months
after laparoscopy at another institution and so the patient could not be investigated.
32
DISCUSSION
With the increasing demand for female sterilisation in recent years there have been
concomitant
technological advancements in an effort to provide safe, effective and
acceptable methods of female sterilisation. For implementing large-scale programmes
in developing countries, methods that are adaptable to varied clinical settings and
are acceptable both to the clinician and patient are needed. Laparoscopy and minilaparo
tomy have been extensively used under varied conditions in a number of countries
including India, and appear to be the most promising of the currently available methods.
While the colpotomy approach has been widely accepted and used in India, in recent
years it has lost some of its popularity owing to the high incidence of complications
reported by some workers. To assist in the search for methods which will best meet
large-scale needs, the India Fertility Research Programme is conducting well controlled,
comparative studies which are designed to scientifically evaluate and compare the
safety, effectiveness and acceptability of a wide range of sterilisation approaches
and techniques in different patient categories.
The present analysis is based on pooled data from studies conducted at different
centres and so all inter-centre variables are not controlled for in this series,
However, by using standard protocols, it has been possible to draw certain
conclusions, This analysis shows that sterilisation can be performed safely and
effectively via laparoscopy, minilaparotomy and colpotomy in postabortion cases.
Operative complication rates were similar for all three approaches and were comparable
to rates reported in a pooled analysis of 2,904 laparoscopy and 532 minilaparotomy
procedures (3). However, there was a significantly higher incidence of immediate and
early postoperative complications and complaints for women undergoing minilaparootmy
in this series. The main reason for the differential in the morbidity rates was the
high incidence of, mostly minor, incision-related complications with minilaparotomy.
Hence, if these problems could be minimized, the complication rates for minilaparotomy
could be substantially decreased and would then compare favourably with the low morbidity
rates reported for laparoscopy in this and other studies (3,12,13). Training in the
procedure is an important factor for minimizing morbidity with all three sterilisation
approaches as knowledge of details of the procedure prevents potential complications.
For laparoscopy, possibly a higher level of skill, qualifications and training are
needed.
The tubal ring technique offers a distinct advantage for laparoscopy as it obviates
the dangers of burns associated with electrocoagulation. For minilaparotomy and
colpotomy, standard ligation techniques may be favoured because of the interrelated
problems of tubal transection due to tubal ring application and problems of providing
special applicators for this technique. Reported failure rates with the tubal ring
were low in this and other studies (6,9,11,18). With the availability of locally
manufactured tubal rings this technique is gaining popularity in India. The better
chances of future tubal reanastomosis, another possible advantage of this technique,
has not been validated so far.
For the successful implementation of service programme, the cost factor is obviously
an important criterion. This includes the initial cost of equipment, maintenance
costs, time of the surgeon and other staff and hospital costs. While the initial
investment and maintenance costs are higher for laparoscopic equipment, this and other
studies (3,12,13) show that surgical and operating room time as well as hospital stay
are considerably lower for this method. In the present study, the incidence of
technical difficulties was not significantly different for the three sterilisation
approaches. Technical failures reported for laparoscopy and colpotomy involved only
33
a change to an alternative sterilisation technique and the planned approach was
successfully employed to complete the procedure. A pooled analysis of data from
several centres showed significantly higher failed procedures for laparoscopy than
for minilaparotomy (3). For large-scale sterilisation programmes, the initial
outlay and the logistical considerations of costs and continued maintenance of
laparoscopic equipment should be weighed against the lower programme costs related
to staff time and hospitalisation. Laparoscopic equipment is being modified to
minimize its costs and to make it more durable, practical and adaptable to field
conditions in developing countries. Early reports with the laparocator, which has
been designed to fulfill these requirements, are encouraging (19,20). Outpatient
sterilisation with minilaparotomy is certainly cost-effective and hospitalisation
for colpotomy is a disadvantage.
The question of late sequelae and menstrual disturbances subsequent to sterilisation
is still unanswered. While some workers believe that there is considerable late
morbidity following sterilisation, results in literature are quite conflicting (21,22)
probably due to the lack of adequate control groups in most studies and the absence
of comparable data from the general female population. It is postulated that the
interruption of the terminal branch of the uterine artery to the ovary results in
ovarian dysfunction (23). The incidence of late morbidity has been related to the
sterilisation procedure and one study showed significantly higher morbidity rates
for laparoscopy than for tubal ligation; this was attributed to increased tissue
destruction and disruption of blood supply by diathermy (21). In the present series,
the incidence of gynaecological abnormalities was significantly higher for colpotomy
than for laparoscopy and minilaparotomy six months after sterilisation. Follow-up
rates were dissimilar for the three groups of cases and later follow-up data are
reported only for laparoscopy and minilaparotomy. While the incidence of gynaecolo
gical abnormalities and complaints and gynaecological surgery was higher for minilapa
rotomy than for laparoscopy, the differences were not statistically significant.
Since the tubal ring techniques damages only a limited segment of the tube, unlike
electrocoagulation, and as the technique for tubal occlusion in this study was the
same for all three approaches, these differentials may be attributed to the surgical
procedures employed to approach the Fallopian tubes. To scientifically evaluate
long-term sequelae following sterilisation, random, controlled long-term follow-up
studies are recommended.
ACKNOWLEDGMENT
The authors gratefully acknowledge the following contributors to the India Fertility
Research Programme who have carefully conducted the comparative studies from which
the data for this paper are drawn: Drs. R.V. Bhatt, S.D. Khandwalla, S. Mehtaji,
N.D. Motashaw and M. Parikh.
34
References
1. Dube; S.; Sharma; D. and Sharma; E.L.N. Problems of female sterilisation by vaginal
approach. J. Obstet. Gynaec. of India; Vol. XXVIII; No. 2; pp 220-224; 1978.
2. Batliwalla; P.R. and Mehtaji; S. Vaginal sterilisation - A review of 1;164 cases.
In: Proceedings of the Seventh Asian Congress of Obstetrics and Gynaecology3 the
Asian Federation of Obstetrics and Gynaecology; 415-424; 1977.
3. McCann; M.F. Laparoscopy versus minilaparotomy. Presented at the Conference of the
Programme for Applied Research for Fertility Regulation; Washington; DC; March 13-16;
1977.
4. WheelesS; C.R. Laparoscopically applied hemoclips for tubal sterilization.
Gynecol. 44: 752; 1974.
Obstet.
5. MotashaW; N.D.; Pachauri; S. and Bhiwandiwalla; P. An evaluation of hemoclips.
Fourth Transaction of Scientific Papers; India Fertility Research Programme; 205-215;
1977.
6. Kessel; E. and McCann; M.F. Laparoscopic tubal occlusion by electrocoagulation;
spring-loaded clip and tubal ring. Presented at the 1st International Congress;
Asian Federation of Obstetrics and Gynaecology; Singapore; April 27-30; 1976.
7. McCann; M.F. and Kessel; E. International experience with laparoscopic sterilization:
Follow-up of 8; 500 women. Presented at the 14th Annual Scientific Meeting; Association
of Planned Parenthood Physicians; Miami Beach; Florida,; November 10-12; 1976.
8. Arnold^ S.W., Morrison; J.C. and Fish; S.A. Puerperal Week clip sterilisation: Study I
(First study of two consecutive studies). Fertil. Steril 27: 2413-1414; 1970.
9. Kwak; H.; Saha; A. and Pachauri; S. Laparoscopic sterilization with tubal ring.
Presented at the Second International Seminar on Maternal and Perinatal Mortality;
Pregnancy Termination and Sterilisation; International Federation of Gynaecology
and Obstetrics; Bombay; India; March 3-5; 1975.
10. Khandwalla; S.D.; Pachauri; S.; Kayak; P.G. and Pai; D.N. A comparative study of
laparoscopic spring-loaded clip and tubal ring techniques of sterilisation in
postabortion cases - One year follow-up. Int. J Gynecol Obstet 16: 115-118; 1978.
11. Lean; T.H.; Vengadasalarri; D. and Cole; P. A comparison of the clip and ring
techniques for laparoscopic sterilization of postpartum and postabortion patients.
Int J Gynecol Obstet 16: 150-156; 1978.
12. Bhatt; R.V.; Pachawri; S.y Chauhari; L.N. and John; E.
A comparative study of the
tubal ring applied via mihilaparotomy and laparoscopy in postabortion cases in
Baroda; India. Int J Gynecol Obstet 16: 115-118; 1978.
13. Motashaui; N.D.; Pachauri; S. and Bhiwandiwalla; P. Sterilization with the tubal
ring via laparoscopy and colpotomy in postabortion cases - A comparative study.
In: Proceedings of the Seventh Asian Congress of Obstetrics and Gynaecology; the
Asian Federation of Obstetrics and Gynaecology; 415-424; 1977.
14. Kochhar; M. Minilaparotomy using the tubal ring. Fifth Transactions of Scientific
Papers; India Fertility Research Programme; 91-92; 1978.
35
15, Dhantaram, S,, Tekumalla, I., Kumar, S., and Hingorani, 7, A comparative study of
the standard Pomeroy and tubal ring techniques of tubal <occlusion via minilaparotomy
Third Transactions of Scientific Papers, India Fertility Research Programme, 167^170^
1977.
16. Mehtajij S.3 Parikh3 V., Batliwalla, P, and Rama Rao^ T, A comparative study of
vaginal and laparoscopic sterilisations following first trimester pregnancy terminatic
Fifth Transactions of Scientific Papers3 India Fertility Research Programme^ 79-83
1978.
17. Wortman^ J. and Piotrow, P.T.
Series C, No. 3, June 1973.
Cotpotomy: The vaginal approach.
Population Report,
18. Kessel^ E.3 Pachaurij S. and McCann, M.F. A comparison of laparoscopic tubal
occlusion by cautery, spring-loaded clip and tubal ring. In: Advances in Female
Sterilization Techniques: Proceedings of a Workshop on Advances in Female Sterili
zation Techniques, Program for Applied Research in Fertility Regulation, Mdneapoliss,
Minnesota, June 15-17, 1975. J.J. Sciarra, W. Droegmueller, and J.J. Speidel (eds).
Hagerstown, Maryland, Harper & Row, p 69-90,1978,
19. Parikh, M.N., Patel, D.N. and Bhiwandiwalla, P. The laparocator - A new instrument
for female steirlisation. Sixth Transactions of Scientific Papers, India Fertility
Research Programme, 60-64, 1978.
20, Bhatt; R.V.
Personal communication, 1979,
21. Neil, J.R., Noble, A.D., Hammard, G.T., Rushton, L. and Letchworth, A.T. Late
complications of sterilization by laparoscopy and tubal ligation. The Lancet,
699-700, October 1975.
22. Khanna, S., Parthasarthi, L., Dube, S. and Gupta, S. Cytohormonal assessment
of ovarian function following tubal ligation. Int J Gynecol Obstet 16: 373-376,
1979.
23. Lu, T., Chun, T. A long-term follow-up study of 1,105 cases of postpartum tubal
ligation. J Obstet Gynaecol Br. Commwlth. 74: 875, 1967,
36
COMPLICATIONS AND SEQUELAE FOR 17,492 STERILISATION
CASES - A FIVE YEAR STUDY
Sareena Mary George, MBBS^
May Manuel3 MD3 DGO2,
ABSTRACT
Complications/sequelae following sterilisation are reported for 645 cases in whom
sterilisation was performed concurrently with caesarian section and/or other
gynaecological surgery and for 2,937 postpartum, 4,225 postabortion and 1,427 interval
sterilisation cases. The incidence of psychological complaints was high for all
patient categories. The incidence of wound infection was highest among postpartum
cases. Menstrual problems were most frequently reported for postpartum and post
abortion cases. The mortality rate for the series was 0.02 percent. The pregnancy
rate was 0.3 percent.
INTRODUCTION
Sterilisation of the female has been of interest to the medical profession since
Hippocrates first proposed it as a means of avoiding perpetuation of insanity
through heredity. Later, this concept was.extended to include the prevention of
other heriditary diseases and conditions which could endanger the life of the
mother. With the population explosion a dynamic change has occurred in the concept
of sterilisation which has been extended from the need of the individual to the
need of the nation. Since sterilisation is now a national need it becomes imperative
to study complications and sequelae of the present day methods of sterilisation
in order to offer the safest available methods to the population.
MATERIALS AND METHODS
In this study, 17,492 women undergoing sterilisation from 1974-1978 at the Madurai
Medical College Hospital, Madurai were included. Sterilisation was performed in all
cases as an inpatient procedure with atleast 8 days hospitalisation. The modified
Pomeroy technique was used in all study cases.
Patient Category:
Women undergoing sterilisation were categorised as follows:
Group I included 1,711 women in whom the sterilisation procedure was performed via
the abdominal route, concurrently with caesarian section and/or other major
gynaecological surgery.
Group II included 4,926 women in whom sterilisation was performed via the abdominal
route, as a postpartum procedure within 48 hours of delivery.
1Senior House Surgeon, 2 Professor of Obstetrics and Gynaecology,
College, Madurai.
Madurai Medical
37
Group III included 7,479 women in whom sterilisation was performed via the abdominal
or the vaginal routes, concurrently with pregnancy termination.
Group IV included 3,376 women in whom sterilisation was performed via the abdominal
or vaginal routes, as an interval procedure 1^ to 2 years after the last
child birth.
Follow-Up
The woman .was advised to return for follow-up after 15 days, Thereafter, she was
advised to visit whenever she experienced any problem or difficulty, At'each review,
a routine pelvic examination was performed. Other relevant examinations were
performed according to the specific complaints, In this series, 52.8 percent of the
Table I shows the follow-up rates for various patient
women were followed up.
categories. Complication/sequelae are reported only for women who were followed-up.
TABLE I
FOLLOW-UP RATES BY PATIENT CATEGORY FOR 17,492 WOMEN UNDERGOING STERILISATION
AT THE MADURAI MEDICAL COLLEGE HOSPITAL, MADURAI, 1974 TO 1978
Type
With Follow-up
No.
%
Without Follow-up
No.
%
Total
No.
%
Group I
Caesarian section and/or
gynaecological surgery
645
37.7
1066
62.3
1711
100.0
Group II
Postpartum
2937
59.6
1989
40.4
4926
100.0
Group III
Pos tabortion
Dilatation and curettage
Vacuum aspiration
Hysterotomy
Extraamniotic saline
Intraamniotic saline
Prostaglandin
4225
1984
1512
252
38
412
27
56.5
52.1
64.3
57.5
58.5
52.0
100.0
3254
1821
839
186
27
381
0
43.5
47.9
35.7
42.5
41.5
48.0
0.0
7479
3805
2351
438
65
793
27
100.0
50.9
31.4
5.9
0.9
10.6
0.4
Group IV
Interval
1427
42.3
1949
57.7
3376
100.0
9234
52.8
8258
47.2
17492
100.0
TOTAL
38
Definitions and Criteria
Complications/sequelae reported within 3 months of sterilisation were categorized as
early. Complications/sequelae reported after 3 months were categorized as late.
RESULTS
Complications/Sequelae
For women who underwent sterilisation concurrently with caesarian section' or other
gynaecological surgery, the most frequently reported early complications were general
debility (7.0%) and wound infection (6.7%) and the most frequently reported late
complications were leucorrhoea (4.0%), menorrhagia (3.9%) and incisional hernia (3.3%)
(Table II).
TABLE II
REPORTED COMPLICATIONS/SEQUELAE BY TIME OF ONSET FOR 645 WOMEN UNDERGOING
STERILISATION CONCURRENTLY WITH CAESARIAN SECTION AND/OR OTHER
GYNAECOLOGICAL SURGERY AT THE MADURAI MEDICAL COLLEGE HOSPITAL, MADURAI,
1974 TO 1978
Time of Onset
Late
Early
No.
%
No.
%
Infection
Wound infection
Urinary tract infection
Thrombophlebitis
To tai
43
7
3
53
6.7
1.1
0.5
8.2
0
16
0
16
0.0
2.5
0.0
2.5
Menstrual disorders
Amenorrhoea
Menorrhagia
Intermenstrual spotting
Oligomenorrhoea
Total
17
13
3
1
34
2.6
2.0
0.5
0.2
5.3
19
25
20
9
73
3.0
3.9
3.1
1.4
11.3
Total
134
45
8
0
187
20.8
7.0
1.2
0.0
29.0
274
102
18
1
395
42.5
15.8
2.8
0.2
61.3
To tai
25
8
26
59
3.9
1.2
4.0
9.1
26
21
47
94
4.0
3.3
7.3
14.6
Complications/Sequelae
Psychological
Nonspecific aches
General debility
Dyspepsia
Dysparunia
Miscellaneous
Leucorrhoea
Incisional hernia
Other
Note: For this table and for Table III, IV and V, complications/sequelae were
categorized as early if reported within 3 months and late if reported
after 3 months of sterilisation.
39
Among the postpartum cases, wound infection (16.7%) was the most frequently reported
early complication. The incidence of leucorrhoea, amenorrhoea and mehorrhagia
was 5.5, 3.9 and 2.4 percent within 3 months. After 3 months, the incidence of
leucorrhoea was 15.6 percent and amenorrhoea was reported in 8.6 percent cases.
The incidence of incisional hernia (0.5%) was low for this series (Table III).
TABLE III
REPORTED COMPLICATIONS/SEQUELAE BY TIME OF ONSET FOR 2,937 WOMEN UNDERGOING
POSTPARTUM STERILISATION AT THE MADURAI MEDICAL COLLEGE HOSPITAL, MADURAI,
1974 TO 1978
Time of Onset
Complications/Sequelae
Early
Late
No.
%
No.
%
Infection
Wound infection
Urinatry tract infection
Thrombophleb i tis
Total
490
33
27
550
16.7
1.1
0.9
18.7
0
86
0
86
0.0
2.9
0.0
2.9
Menstrual Disorders
Amenorrhoea
Menorrhagia
Intermenstrual spotting
01igomenorrho ea
Dysmenorrhoea
To tai
115
71
15
6
1
208
3.9
2.4
0.5
0.2
0.0
7.1
252
179
70
49
41
591
8.6
6.1
2.4
1.7
1.4
20.1
To tai
873
327
49
0
1249
29.7
11.1
1.7
0.0
42.5
1600
735
125
11
2471
54.5
25.0
4.3
0.4
84.1
Total
162
2
211
375
5.5
0.1
7.2
12.8
459
15
326
800
15.6
0.5
11.1
27.2
Psychological
Nonspecific aches
General debility
Dyspepsia
Dysperunia
Miscellaneous
Leucorrhoea
Incisional hernia
Other
When sterilisation was performed concurrently with pregnancy termination, menorrhagia,
leucorrhoea and wound infection were reported in 10.0, 8.9 and 6.9 percent cases
respectively, within 3 months of sterilisation. The most frequently reported late
complications in this series were leucorrhoea (13.9%) and menorrhagia (7.4%) (Table IV>
40
TABLE IV
REPORTED COMPLICATIONS/SEQUELAE BY TIME OF ONSET FOR 4,225 WOMEN UNDERGOING
STERILISATION CONCURRENTLY WITH PREGNANCY TERMINATION AT THE MADURAI MEDICAL
COLLEGE HOSPITAL, MADURAI,’1974 TO 1978
Time of Onset
Complications/Sequelae
Early
Late
No.
%
No.
%
Infection
Wound infection
Urinary tract infection
Thrombophlebitis
Pelvic infection
Total
290
71
57
35
453
6.9
1.7
1.4
0.8
10.7
0
151
0
29
180
0.0
3.6
0.0
0.7
4.3
Menstrual Disorders
Menorrhagia
Amenorrhoea
Intermenstrual spotting
01igomeno rrho ea
Dysmenorrhoea
Total
422
111
49
17
11
610
10.0
2.6
1.2
0.4
0.3
14.4
312
159
142
118
28
759
7.4
3.8
3.4
2.8
0.7
18.0
Gynaecological Problems
Prolapse uterus
0
0.0
4
0.1
Total
1678
478
72
0
2228
39.7
11.3
1.7
0.0
52.7
2530
1058
213
14
3815
59.9
25.0
5.0
0.3
90.3
To tai
375
1
0
3^3
739
8.9
0.0
0.0
8.6
17.5
587
7
18
608
1220
13.9
0.2
0.4
14.4
28.9
Psychological
Nonspecific aches
General debility
Dyspepsia
Dysparunia
Miscellaneous
Leucorrhoea
Incisional hernia
Scar endometriosis
Other
Among the interval sterilisation cases, wound infection (7.8%) and leucorrhoea (5.0%)
were the most common early complications and leucorrhoea (13.3%) and menorrhagia (4-2%)
were the most frequently reported late complications (Table V).
The incidence of wound infection was highest among postpartum (16.7%) cases and it was
6 to 8 percent among the other patient categories. For all patient categories, the
reported incidence of leucorrhoea ranged between 3.9 to 8.9 percent within 3 months
and 4.1 to 15.6 percent after 3 months of sterilisation.
The incidence of psychological complaints was high for all categories; it was highest
for the postpartum (84.1%) and postabortion (90.3%) cases (Tables III and IV).
41
TABLE V
REPORTED COMPLICATIONS/SEQUELAE BY TIME OF ONSET FOR 1,427 WOMEN UNDERGOING
INTERVAL STERILISATION AT THE MADURAI MEDICAL COLLEGE HOSPITAL, MADURAI,
1974 TO 1978
Time of Onset
Complications/Sequelae
Early
No.
%
No.
%
Infection
Wound infection
Urinary tract infection
Pelvic infection
Thrombophlebitis
Total
111
20
10
5
146
7.8
1.4
0.7
0.4
10.2
0
31
4
0
35
0.0
2.2
0.3
0.0
2.5
Menstrual Disorders
Amenorrhoea
Menorrhagia
Intermenstrual spotting
Oligomenorrhoea
Dysmenorrhoea
29
26
10
4
2
Total
71
2.0
1.8
0.7
0.3
0.0
5.0
35
60
38
16
15
164
2.5
4.2
2.7
1.2
1.1
11.5
Total
0
0
0
0
0
0.0
0.0
0.0
0.0
0.0
3
1
1
1
6
0.2
0.1
0.1
0.1
0.4
Total
312
113
25
2
450
21.9
8.0
1.8
0.0
31.5
637
289
42
15
976
44.6
20.3
2.9
1.1
68.4
Total
71
110
181
5.0
7.7
12.7
190
182
372
13.3
12.8
26.1
Gynaecological Problems
Prolapse
Uterine myoma
Ovarian tumour
Cancer cervix
Psychological
Nonspecific aches
General debility
Dyspepsia
Dysparunia
Miscellaneous
Leucorrhoea
Other
Late
The incidence of menstrual complaints within three months of sterilisation was highest
among postabortion(14.8%) cases. Menorrhagia (10.3%) was the most frequently reported
menstrual problem in this group of cases. The incidence of menorrhagia was 2.9 to 3.8
percent in the other patient categories. The incidence of amenorrhoea ranged between
2.7 to 5.0 percent for various patient categories (Fig 1).
42
Amenorrhoea
Inter-mens trual
Spotting
Menorrhagia
5
Total
14.8
10.3.
9.9
<<<<•
8.4
5
□
5.0
■■•I
aaai
3.8
■ aai
aaai
«an
aaai
aaai
aaai
aaai
aaai
aaai
aaai
4.7
SS9
2.9
w
saaS
•.v.vz
::ao .9
ww■W
3
aaai —
With Caesarian
Section and/or
Gynaecological
Surgery
8.2
laaad
■a
lassa
isaaq
laaai
■■■a
.6
ill
gss
2.7
l»J*C
Kaa
Kaa
3 .0
.2
Eaa
Postpartum
Postabortion
Interval
Fig 1
MENSTRUAL DISORDERS WITHIN THREE MONTHS OF STERILISATION AT THE MADURAI MEDICAL
COLLEGE HOSPITAL, MADURAI, 1974 TO 1978
After 3 months of sterilisation, the highest incidence of menstrual problems was reported
for the postpartum (14.2%) cases;it was 12.7 percent for the postabortion cases and also for
those m whom sterilisation was performed concurrently with caesarian section or other
gynaecological surgery, and was 10.5 percent for the interval sterilisation cases.
The incidence of amenorrhoea was 2.3 to 6.1 percent and that of menorrhagia was 3.9 to
5.2 percent for the various patient categories (Fig 2).
Mortality
There were 3 deaths in the series, Thus the mortality rate was 0.02 percent. While
one death was reported for a woman undergoing postpartum sterilisation, two were reported
among women in whom sterilisation was performed concurrently with caesarian section or
other gynaecological surgery.
43
I—I Total
Menorrhagia
Inter-mens trual
Spotting
Amenorrhoea
L5
14.2
12.7
12.7
10.5
c
6.1
C
5.2
5
4.0
4.3
2.7 ,
3.1 3.
X;
1.7
ft*::
*::ft
ft®
2.4 :ft:g
3.9
2
2.4
::::
Sw
X;
0
With Caesarian
Section and/or
Gynaecological
Surgery
Postparturn
Postabortion
Interval
Fig 2
MENSTRUAL DISORDERS AFTER THREE MONTHS OF STERILISATION AT THE MADURAI
MEDICAL COLLEGE HOSPITAL, MADURAI, 1974 TO 1978
Pregnane ies
There were 49 pregnancies in the series; the pregnancy rate for the total series was
0.3 percent. The pregnancy rate was 0.5 percent for cases in whom concurrent caesarian
section or pelvic surgery was performed, 0.2 percent for postpartum cases, 0.3 percent
for postabortion cases and 0.3 percent for interval cases. One ectopic pregnancy was
reported.
44
COMMENT
A high percentage of women undergoing sterilisation reported psychological complaints
such as general debility and non-specific aches and pains. These complaints were
successfully treated with symptomatic or even placebo therapy.
The incidence of leucorrhoea within 3 months of sterilisation ranged between 3.9 to
8.9 percent for the various patient categories; it was 4.0 to 15.6 percent after
three months. This complaint was attributed to prior local pelvic pathology which
was, probably, not recognized before sterilisation.
The author believes that tubal ligation per se does not cause menstrual disturbances.
Khanna et al (1) and Nandekar (2) showed that ovarian activity was not reduced after
the tubectomy procedure. In this study, patients with menstrual problems did not
require any major medical or surgical treatment. The authors recommend that in the
case of high parity women menstrual history should be carefully evaluated prior to
sterilisation and hysterectomy should be be considered in cases with a history of
menorrhagia.
As female sterilisation is used extensively on a nation-wide basis, it is important
to consider its risks and benefits. In this analysis, the complications and sequelae
of sterilisation are evaluated to highlight the risks associated with presently used
methods. Further prospective long-term follow-up studies are recommended for further
evaluation.
References
1. Khanna, S., Parthasaruthi, I., Dube, S. and Gupta, S. Cythohormonal assessment
of ovarian function following tubal ligation. Int. J Gynecol. Obstet. 16: No. 5,
373-276^ 1979.
2. Nandekar^ V.
M.G.M. Medical College^ Indore Unpublished data.
45
EXPERIENCE WITH LOW WATTAGE BIPOLAR CAUTERIZATION OF THE TUBES
FOR FEMALE STERILISATION - A FOLLOW-UP STUDY
7
R. Merchant> MD, DGO, FICS1
ABSTRACT
Prehysterectomy studies on 10 cases and clinical trial of 53 women undergoing
sterilisation with the low wattage bipolar cauterization technique are reported.
The technique is described. The results of these studies indicate that this
technique is safe and effective and offers a better potential for recanlization
since tubal damage is minimized. The advantages of this method over the unipolar
cauterization and tubal ring techniques are discussed.
INTRODUCTION
It is universally acknowledged that the electrosurgical cauterization of the
tubes via laparoscopy is an easy and effective method of female sterilisation (1,2).
Unfortunately, the electrical system has not lived upto its former expectations
because of the rare but serious complication of bowel burns with the high frequency
unipolar instrument (3,4,5) and fear of a failure, however, rare with the bipolar
instrument. This method, therefore, no longer enjoys universal acceptability.
The gynaecological world is consequently losing interest in electrosurgical techniques.
However, bipolar electrosurgery has several advantages (6,7). This study was under
taken to evaluate the low wattage bipolar cauterization technique of female steri
lisation.
MATERIALS AND METHODS
Basic Principles of Electrosurgery
With the unipolar system of electrosurgery, a high frequency current is delivered
through a small active electrode (Fig 1). The density of the current at the point
of contact causes wide destruction of the tissues by dissolution of its molecular
structure. As the current returns to the ground plate and finally to the generator
a large area of the tube is invariably destroyed. The neighbouring mesosalpinx
may also be destroyed, thereby, endangering the tubal blood supply and frequently
resulting in excessive necrosis of the tube which may render a future tubal
anastomosis almost impossible. The onward journey of the current from the tube to
the ground plate is unpredictable as it seeks the path of least resistance and in
doing so may cause damage to the person of the operator and also cause burns to the
bowel or whatever tissue is in its way.
The bipolar principle eliminates the faults inherent in the unipolar technique,
In this case, the electrodes are placed within the instrument itself so that the
current passes selectively from, one prong of the forceps to the other and so destroys
Honorary Associate Obstetrician & Gynaecologist, B.Y.L. Nair Hospital,
Honorary Associate Professor, Obstetrics & Gynaecology, T.N. Medical College, and
Director, Obstetrics & Gynaecology, Dr. Merchant’s Hospital, Bombay.
<
46
UNIPOLAR SYSTEM
BIPOLAR SYSTEM
Fig 1
PATH OF CURRENT WITH THE UNIPOLAR AND BIPOLAR SYSTEMS
only that tissue which is interposed between the prongs (Fig 1). In this system,
the ground plate is eliminated along with its danger of intraabdominal sparking
and injury to intraabdominal viscera. As in this case the current has to traverse
only a short distance between the two prongs of the forceps and has to destroy
only a small portion of the tissue that is held between the prongs, a very low
voltage of current is needed and the final low wattage of current required for
the purpose is safe for intraabdominal use. Furthermore, the low temperature
obtained at low wattage eliminates over-heating of the forceps and the associated
inadvertent accidental damage which can occur on contact with tissues while
withdrawing the forceps. Thus, the destruction of tubal tissue is limited to a
small area and does not extend to the mesosalpinx. This factor is most critical
as it has important implications for future surgical reversal.
Prehysterectomy Study
The procedure was performed 6 to 12 weeks prior to hysterectomy in ten
women who were scheduled for hysterectomy and who consented to participate in the
study. The Fallopian tubes were cauterized with the Storz bipolar coagulator and
bipolar grasping forceps, using the Storz single puncture laparoscope. Coagulation
for 80 to 180 seconds (depending upon the thickness of the tubes), at a setting of
50 on the Storz bipolar coagulator, was found to produce optimum results. Histopathologically, the effects of cauterization were similar to those obtained with
the classical unipolar method.
Studies of the hysterectomy specimens included: (a) macroscopic examination of the
tubes, (b) cryosectioning, (c) histopathological examination and (d) hysterosalpingogram of the complete specimen.
47
Clinical Study
From January 1977 to June 1979, 53 women underwent sterilisation with the low
wattage bipolar cauterization technique. All procedures were performed by the
author. In the majority of the cases intravenous analgesia and local anaesthesia
were used. The following are some of the important details of this techniaue:
(1) By correct placement of the atraumatic forceps, the full thickness of the tube
should be grasped so that when the jaws of the forceps are closed they completely
encircle the tube. Care should be taken to ensure that the mesosalpinx is avoided.
(2) The tube should be coagulated at a single site about 3 cm from the uterine
cornu. Division or severance of the tube should be avoided. (3) Depending on
the thickness of the tube, a current should be passed for a minimum of 80 and
maximum of 180 seconds at a setting 50. Almost simultaneously, the fluid in
the tissue starts boiling (as evidenced by the appearance of bubbles) and steam
is liberated. The effected portion of the tube gets dessicated and flattens out
within the jaws of the forceps. On withdrawal of the forceps, approximately 5 mm
of the tube are completely coagulated and a 2 to 3 mm area on either side of the
tube shows lower degrees of coagulation. Thus, not more than about one centimetre
of the tube is cauterized and a reasonable length of the tube is conserved for
possible future reversibility. The study subiects were scheduled for follow-up
at 7 days, 3 months and yearly thereafter.
RESULTS
Prehysterectomy Study
The following results were reported in cases in whom hysterectomy was performed
six weeks after tubal cauterization:
On macroscopic examination, the coagulated area of the tube was found to be
dull grey in colour and slightly shrunken, The neighbouring areas showed hypermia
but no adhesions were seen, On histopathological examination, the coagulated
area revealed avascular necrosis of all the coats of the tube; the tubal mucosa was
totally destroyed' (Fig 2). The area immediately adjacent to the coagulated
portion revealed a lesser degree of necrosis and damage (Fig 3).. A section through
in any of the
an area 5 mm away from the coagulated site revealed no changes
(
coats of the tube and the mucosa was intact.
Fig 2: FALLOPIAN TUBE SIX WEEKS AFTER CAUTERIZATION, SHOWS AVASCULAR NECROSIS OF
ALL THE COATS AND TOTAL DESTRUCTION OF THE TUBAL MUCOSA
48
Lt
m
>■/>-
Fig 3: SECTION OF FALLOPIAN TUBE 5 MM AWAY FROM COAGULATED SITE SIX WEEKS AFTER
CAUTERIZATION SHOWS NO CHANGE AND INTACT MUCOSA
The following results were reported when hysterectomy was performed twelve weeks
after tubal cauterization:
On macroscopic examination, the coagulated area appeared whitish and was shrivelled
to a thin cord. Histologically, intense fibrosis was evident m all the coats o
the tube as shown with Masson's trichrome stain. The tubal lumen was lost m t e
scar tissue (Fig 4). Adhesions in the surroundings were conspicuous by their
absence. The hysterosalpingogram confirmed that the occlusion of the lumen was total.
5
-------- SHOWS LOSS OF TUBAL
Fig 4: FALLOPIAN TUBE TWELVE WEEKS AFTER CAUTERIZATION
NO jjrr.zzzcrz
ADHESIONS I?
IN’ SURROUNDING TISSUES
lumen in scar tissue, i"
Clinical Study
The mean age of the women in the study group was 30.9 years; their mean parity
was 2.5. More than half of the women in the series had completed high school
(Table I).
While 9 women were followed up within 8-11 months, 26 were followed up within
12-24 months and 18 within 25-36 months.
49
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 53 WOMEN UNDERGOING STERILISATION WITH THE LOW
WATTAGE BIPOLAR CAUTERIZATION TECHNIQUE, BOMBAY, 1977 TO 1979
Number
Percent
Age (Years)
21 - 25
26 - 30
31 - 35
36 - 40
Mean
4
23
17
9
7.5
43.4
32.1
17.0
Parity
1
2
3
Mean
2
23
28
Sociodemographic Characteristics
Patient’s Education (School years)
< 10
10 +
30.9
3.8
43.4
52.8
2.5
23
30
43.4
56.6
There were no technical failures or surgical difficulties. The procedure was
successfully completed in all cases. No immediate or delayed complications were
reported within the two year follow-up period. No menstrual irregularity was
reported. No pregnancies have been reported so far. Three of the study subjects
underwent hysterosalpingography six to twelve months after sterilisation. In all
three cases complete occlusion in the juxtauterine part of the tube was noted (Fig 5).
Fig 5: HYSTEROSALPINGOGRAM SHOWS COMPLETE OCCLUSION IN THE JUXTAUTERINE
PART OF BOTH TUBES
50
DISCUSSION
The results of the prehysterectomy and clinical studies indicate that the low wattage
bipolar technique is safe and effective. This technique appears to offer a better
potential for future surgical recanlisation since with this method only about one
centimetre of the isthmic portion of the tube is sacrificed (8).
The mesosalpinx
with its blood supply is effectively spared from the ravages of electrocoagulation.
In sharp contrast to this, tubal cauterization with the unipolar high frequency
current results in the destruction of a larger area of the tube and often includes
the mesosalpinx. Over half the length of the tube is usually destroyed leaving a
chance of just 17 percent for Successful reversal later (9). While sterilisation
should be regarded as a final end to child-bearing, in view of the ever increasing
number of sterilisations that are performed and the gradually increasing requests
for reversals, especially from younger women who might experience child loss sub
sequent to sterilisation, the potential for reversal is an important criterion in
selecting the sterilisation technique. Winston emphasized that the success of
surgical recanalisation is directly proportional to the total available length of
the oviduct (9). At attempted recanalisation in rabbits, Boeckx reported that with
the Falope ring a 1.5 to 2 cm segment of the rabbit’s oviduct was destroyed (10).
In human beings,the segment-wise destruction could be larger because of the shape
occluded. The tubal segment lost between the prongs of an atraumatic
of the loop
occluded.
forceps with low voltage bipolar coagulation is not more than about one centimetre.
Although there has been no occasion for reversal in this small series of cases, the
author feels that with this technique the chances of a successful outcome are
favourable. Furthermore, as the tubal blood supply is not effected with this method
it does not result in menstrual disturbances. This sterilisation method reduces the
danger of intraabdominal sparking and thereby, enhances the safety factor, The
author recommends that the safety, effectiveness and reversability with this method
of female sterilisation should be scientifically investigated through clinical trials.
CONCLUSIONS
The present study permits the following conclusions:
. Low wattage bipolar cauterization results in successful occlusion of the tubes.
However, long-term follow-up is needed to document the effectiveness of this
technique.
. A low wattage current at a setting 50 for 100 seconds produces optimum results.
. The risk of serious complications which is inherent with the high frequency
unipolar current is considerably minimized with this technique.
. Tubal cauterization is limited to only about one centimetre of the tissue between
the prongs of the forceps which is an improvement over other methods of laparoscopic
sterilisation.
. The mesosalpinx with the tubal blood supply is free from damage enabling future
reversal and minimizing resulting menstrual disorders.
51
ACKNOWLEDGMENT
The author expresses indebtedness to Prof. E. D1Souza, Head of the Department of
Anatomy, Prof. S.M. Purandare and Dr.(Mrs) Prabhu from the Department of Pathology
for their help in cryosectioning and histological examination. The help of the
following persons is acknowleged: Dr. Gopi Shenoy, Registrar, Dr. S.S. Thakur,
Department of Obstetrics and Gynaeclogy and
other staff members. The author
thanks Dr. Chandani Alwani, Head of the Department of Obstetrics and Gynaecology,
Dr. M.S. Kekre, Dean of the B,Y.L. Nair Hospital and T.N. Medical College for
giving permission to use the hospital records.
References
1. Black, W.P. Sterilization by laparoscopic tubal electrocoagulation.
Am. J. Obstet. Gynec. Ill: 979-983, 1971.
An Assessment.
2. Cohen, M.R., Taylor, M.B., Kass, M.B., Interval tubal sterilization via laparoscopy
Am. J Obstet. Gynec. 108: 458-461, 1970.
3. Corson, S.L., Patrick, H.H., et al. Electrical consideration of laparoscopic
sterilization. J. Reprod. Med. 11: 159-164, 1973.
4. Shell, J.H. and Myers, R.C. Small bowel injury after laparoscopic sterilization.
Am. J Obstet. Gynec, 115: 285, 1973.
5. Thompson^ B.H. and Wheetess, C.R. Gastrointestinal complication of laparoscopic
sterilization, Obstet. Gynec. 41: 669-76, 1973.
6. Jacques, E. Rioux, and Diogene Cloutier. True bipolar electro surgery for tubal
sterilization by laparoscopy. Gynaecological laparoscopy. Edited by Jordon M.
Phillips Stratton, Intercontinental Medical Book Corporation, p 315.
7. Semm, K. Atlas of Gynecologic laparoscopy and Hysteroscopy.
Stephen Borrow, W.B. Saunders Company, 1977.
Edited by Lawrence
8. Winston, R.M.L.
Reversibility of sterilizcction. International Planned Parenthood
Federation Medical Bulletin, Vol. 12, No. 6, December 1978.
9. Winston, R.M.L. Micro surgical reanastomosis of the Rabbit oviduct and its functions
path sequelae. Br. J Obstet. Gynaec. 82: 513-522, 1975.
10. W.D. Boeckx, Gloria, V. and Brosens, I.A. Reversibility of tubal ring steriliza,tion
Contraception. Vol 15, No. 4, p 505, 1977.
IaIM 130
'^r ubbmw
(A
oocumentation
) -
52
FEMALE STERILISATION SERVICES IN RURAL INDIA - PROBLEMS AND SOLUTIONS
7
-- — -^2
3
P.V. Bhatt, MD, DOT Saro^j Pachauri; MD3 DPH, PhD' L,N< Chauhan, MD'
Saroj
Maru,
BSc
4
K.M. Jariwala^ MD3 DGcfe Anuradha Shirks
Shvrke3 MA^
MA4 >
ABSTRACT
This is a report of 4,948 women undergoing sterilisation at periodic camps in Baroda
District. Their mean age was 28.7 years and mean parity was 4.0. More than half the
women and a fourth of the husbands had received no formal education. Only 1.4 percent
of the couples had used a contraceptive. The vast majority of the sterilisation pro
cedures were performed with regional anaesthesia, via laparotomy and with modified
Pomeroy technique.
Mean surgical time was 16.3 minutes and mean hospital stay was 8.9 nights. Eight
(0.2%) technical failures were reported. The incidence of surgical difficulties was
0.4 percent. Two deaths were reported. Operative and early postoperative complication
rates were 0.2 and 3.4 percent respectively. The incidence of early postoperative
complaints was 17.0 percent. The incidence of gynaecological abnormalities was 2.7,
5.4, 5.3 and 2.9 percent at the 6, 12, 18 and 24 months follow-up visits^respectively;3.1,
7.9, 7.4 and 5,0 percent of the women respectively reported complaints. Gynaecological
surgery was performed in 3.4 percent cases. The pregnancy failure rate was 0.06
percent.
INTRODUCTION
In recent years, the camp approach has been widely used in India for providing
sterilisation services to rural areas. While rural communities have the greatest need
for such services, the infrastructure needed for organising these services is inadequate
in rural areas and even the available facilities are generally inaccessable to most
rural populations. In India, mobile camps are extensively used as a service delivery
mechanism for providing sterilisation services in rural areas. Generally large-scale
camps are organized on a one-time basis to meet the demand for sterilisation. This
mass approach has been criticised as it is associated with several disadvantages.
The limited staff available at the camp site after the visiting team leaves is unable
to provide adequate postoperative care to the large number of women who have been
sterilised and this results in high complication rates which in turn affects patient
acceptability.
This paper reports our experience in rural areas with periodic, small camps, The
objective of this approach is to provide high quality services through camps and also
s trengthen the existing infrastructure in rural areas by training the local physicians
in surgical procedures. This approach was developed to ensure continuing service
delivery even after the camps are discontinued.
1 Professor & Head, “1’Research Assistant, 4 Social Worker, Department of Obstetrics and
Gynaecology, Baroda Medical College, Baroda.
^Research Director, India Fertility Research Programme, Hyderabad.
53
MATERIALS AND METHODS
The experience of 4,948 women undergoing sterilisation between 1972 and 1978 at
bi-weekly camps organized in the Baroda District of Gujarat by visiting teams from
the Department of Obstetrics and Gynaecology at the Baroda Medical College Hospital
is reported.
All data for this study were recorded on standard forms of the India Fertility
Research Programme. Data are reported on sociodemographic and fertility
characteristics of women sterilised at the camps, surgical time and hospital stay,
technical failures, surgical difficulties, complications and failure rates. The
number of cases followed up at 6, 12, 18 and 24 months was 224, 203, 243 and 617
respectively.
Sterilisation camps were organized at six Primary Health Centres (PHCs), The PHC
facilities that were used for camps usually had five maternity beds, a labour room,
and areas where prenatal and child health clinics were held. Since these health
centres have no regular operating theatres, artificial lighting, equipment for
sterilising instruments, and a source of running water had to be improvised. Natural
lighting was most often relied upon, but a battery-operated light was used when
necessary. Instruments were sterilised in boiling water on a kerosene stove, and a
brass tank was filled to provide running water.
The local PHC staff were responsible for: (i) visiting the area to motivate women
for sterilisation, (ii) making local arrangements for camps, (iii) assisting the
visiting team during the camp and (iv) providing follow-up care after the visiting
team left the PHC. The resident medical officers at these PHCs have since been trained
to provide surgical sterilisation at these facilities, The team has moved to provide
services and train the local physicians at other PHCs.
Definitions and Criteria
Technical failure was defined as a case in which the designated procedure could not
be completed, Technical difficulty was defined as any difficulty associated with the
equipment. Surgical difficulty was defined as any difficulty encountered during the
procedure which was not due to equipment-related problems, Surgical time was defined
as the time from the initial incision to final closure.
Complications and complaints were categorized as operative and early postoperative.
Opererative. complications were.those occurring during surgery. Early postoperative
complications and complaints were those reported within the first three weeks after
surgery.
All statistical tests were performed using a significance level (p value) of 0.05.
RESULTS
Sociodemographic Characteristics
The mean age of women undergoing sterilisation in camps was 28.7 years; 45.4 percent
were 30 years or older. Their mean parity was 4.0; 41.8 percent had less than four
live births and 30.1 percent had five or more live births. The mean number of living
children for this group of women was 3.7; 22.0 percent had five or more living children
(Table I).
54
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 4,948 WOMEN UNDERGOING STERILISATION IN SMALL
CAMPS IN BARODA DISTRICT, NOVEMBER 1972 TO AUGUST 1978
Sociodemographic Characteristics
Number
Percent
3
588
2108
1664
495
90
0.1
11.9
42.6
33.6
10.0
1.8
Age (Years)
<
20 25 30 35 40 +
Mean
20
24
29
34
39
28.7
Parity
2
3
4
5
6
7 +
Mean
11.3
30.5
28.1
15.6
8.4
6.1
560
1509
1391
771
415
302
4.0
Number of Living Children
< 2
3-4
5-6
7 +
Mean
13.7
64.2
19.3
2.7
679
3177
956
136
3.7
Patient’s Education (School years)
0
1 - 3
4-6
7-9
10 +
Mean
2802
413
839
615
279
56.6
8.3
17.0
12.4
5.6
2 .5
Husband’s Education (School years)
0
1-3
4-6
7-9
10 +
Mean
*For those women who are currently married.
26.8
10.1
25.7
17.6
19.8
1323
499
1269
870
979
5.0
55
TABLE I (CONTD)
Number
Percent
4940
8
99.8
0.2
Hindu
Muslim
Other
4445
481
22
89.8
9.7
0.4
Gainfully employed
No
Yes
Unknown
4871
76
1
98.4
1.5
0.0
1652
3294
2
33.4
66.6
0.0
4877
27
26
6
5
4
3
98.6
0.5
0.5
0.1
0 .1
0.1
0.1
Sociodemographic Characteristics
Marital Status
Currently married
Formerly married
Religion
Residence
Rural
Urban
Unknown
Previous Contraceptive Practice
None
IUD
Condom
Orals
Tub ectomy
Vas ec tomy
Rhy thm/wi thdrawal
More than half the women and a fourth of the husbands had received no formal education;
their mean educational achievement was 2.5 and 5.0 years of formal schooling respectively
The vast majority of the women were unemployed (98.4%), Hindu. (89.8%) and one third
were from rural areas (Table I).
Prior Contraceptive Experience
Only 1.4 percent of the couples had used a contraceptive method prior to sterilisation.
It is of interest to note that five women and four men had previously undergone a
sterilisation operation (Table I).
56
Pregnancy Wastage and Child Loss
The reported incidence of induced and spontaneous abortions was 1.4 and 25.4 per 1000
pregnancies respectively and that for stillbirths was 5.4 per 1000 pregnancies, The
child loss rate reported for this series was 83.6 per 1000 live births (Table II).
TABLE II
PRIOR PREGNANCY WASTAGE AND CHILD LOSS FOR 4,948 WOMEN UNDERGOING
STERILISATION IN SMALL CAMPS IN BARODA DISTRICT, NOVEMBER 1972
TO AUGUST 1978
Pregnancy Wastage/Child Loss
Numb er
Rate/1000
Induced abortion*
Spontaneous abortion*
Stillbirth*
Child loss**
26
479
102
1527
1.4
25.4
5.4
83.6
*Rates based on the total number of pregnancies.
**Rate based on the number of live births.
Prior Surgery and Preexisting Medical Conditions
Previous pelvic surgery was reported for 27 (0.5%) and prior abdominal surgery for
21 (0.4%) women respectively. About a third of the women undergoing sterilisation
had less than 10 grams haemoglobin, 12 (0.5%) were overweight, 50 (1.0%) had systemic
disease and 10 (0.2%) had pelvic infection (Table III).
TABLE III
PREEXISTING MEDICAL CONDITIONS AND PRIOR SURGERY FOR 4,948 WOMEN UNDERGOING
STERILISATION IN SMALL CAMPS IN BARODA DISTRICT, NOVEMBER 1972 TO AUGUST
1978
Condition
Haemoglobin (<10 gms)
Systemic disease
Overweight*
Pelvic infection
Pelvic surgery
Abdominal surgery
*Weight was reported for interval cases.
Numb er
Percent
1592
50
12
10
27
21
32,2
1.0
0.5
0.2
0.5
0.4
57
Concurrent Surgery
In this series 29 (0.6%) women underwent other surgical procedures concurrently with
sterilisation. In 19 cases dilatation and curettage was performed. Cysts were
removed in five and lysis of adhesions was performed in two cases.
Three women
underwent other procedures.
Sterilisation Approach, Method and Technique
While half of the sterilisations were interval procedures, 39.6 percent were postpartum
and 9.1 percent were postabortion procedures. The vast majority of the sterilisation
procedures were performed via laparotomy (98.6%), 1.3 percent were performed via
colpotomy; the modified Pomeroy technique was used in all except ten cases. Sterili
sation was performed via laparoscopy in 105 (2.1%) cases. In these cases, the tubes
were occluded by the electrocoagulation technique in 86.7 percent, by the tubal ring
technique in 12.4 percent and by the.,modified Pomeroy technique in 1.0 percent cases.
Anaesthesia
The vast majority of the sterilisation procedures were performed using regional
anaesthetics (92.4%). Local anaesthestics were used in 6.8 percent cases and in
0.6 percent cases general anaesthetics were employed.
Surgical Time and Hospital Stay
Mean surgial time for performing sterilisation was 16.3 minutes,
procedures were performed within 10 to 19 minutes (Table IV).
Most (80.0%) of the
The majority (87.5%) of the women were hospitalised for seven or more nights. Mean
hospital stay for the series was 8.9 nights (Table V). Mean postoperative hospital
stay was 7.3 nights.
TABLE IV
SURGICAL TIME REPORTED FOR 4,948 WOMEN UNDERGOING STERILISATION IN SMALL CAMPS
IN BARODA DISTRICT, NOVEMBER 1972 TO AUGUST 1978
Surgical Time (Minutes)
<
10 20 30 40 +
Mean
10
19
29
39
Numb er
Percent
40
3950
829
52
66
0.8
80.0
16.8
1.1
1.3
16.3
58
TABLE V
HOSPITAL STAY FOR 4,948 WOMEN UNDERGOING STERILISATION IN SMALL CAMPS IN
BARODA DISTRICT, NOVEMBER 1972 TO AUGUST 1978
Hospital Stay (Nights)
0 - 1
2 - 4
5 - 6
7 +
Unknown
Mean
Numb er
Percent
61
71
465
4331
20
1.2
1.4
9.4
87.5
0.4
8.9
Technical Failures
In 8 (0.2%) cases the planned technique could not be successfully performed on
one or both sides and alternative techniques were used for occluding the Fallopian
tubes. The most common causb of technical failures was the presence of adhesions.
Surgical Difficulties
Surgical difficulties were encountered during 18 (0.4%) procedures. In 11 (0.2%)
cases surgical difficulty was due to the presence of adhesions. In 4 (0.1%) cases
therte wAs some difficulty in visualizing or exteriorizing the tubes (Table VI).
TABLE VI
SURGICAL DIFFICULTIES REPORTED FOR 4,948 WOMEN UNDERGOING STERILISATION IN SMALL
CAMPS IN BARODA DISTRICT, NOVEMBER 1972 TO AUGUST 1978
Surgical Difficulty
Adhesions
Difficulty in visualizing/exteriorizing
the tubes
Difficulty in opening peritoneum
Ovarian cyst
Other
TOTAL
Number
Percent
11
0.2
4
1
1
1
0.1
0.0
0.0
0.0
18
0.4
59
Complications
The operative complications reported for the series were bowel or bladder injury in
6 (0.1%) and spinal shock in 5 (0.1%) cases.. Early postoperative complications were
was the
reported for 3.4 percent cases% Fever
1--- --. - most frequently reported complication.
Of the 82 (1.6%) cases with fever, 35 (0.7%) required antibiotics. Two patients
developed peritonitis (Table VII).
TABLE VII
OPERATIVE AND EARLY POSTOPERATIVE COMPLICATIONS REPORTED FOR 4,948 WOMEN
UNDERGOING STERILISATION IN SMALL CAMPS IN BARODA DISTRICT, NOVEMBER
1972 TO AUGUST 1978
Complications
Operative:
Bowel/bladder injury
Spinal shock
Tota 1
Early postoperative:
Fever not requiring antibiotics
Fever requiring antibiotics
Pelvic peritonitis
Incision complications
Infection
Dehiscence
Haematoma
Other
Total
Number
Percent
6
5
11
0.1
0.1
0.2
47
35
2
0.9
0.7
0.0
50
27
1
6*
168
1.0
0.5
0.0
0.1
3.4
Complaints
The incidence of early postoperative complaints was 17.0 percent. The most common
of these complaints were related to the use of spinal anaesthetics (7.7%). While
pelvic pain and backache were reported by 4.3 and 1.6 percent cases respectively,
the incidence of incision—related complaints was 1.7 percent (Table VIII).
Mortality
Two deaths occurred in this series. One patient died as a result of spinal shock after
she received spinal anaesthesia. The second woman developed tetanus on the eighth day
after sterilisation and died on the ninth postoperative day. She had had an incompleted
abortion at home 15 days before sterilisation and presumably acquired the tetanus
infection at that time; ten women were sterilised on the same day and none developed
tetanus. The mortality rate for this series was 0.04 percent.
60
TABLE VIII
EARLY POSTOPERATIVE COMPLAINTS REPORTED FOR 4,948 WOMEN UNDERGOING STERILISATION
IN SMALL CAMPS IN BARODA DISTRICT, NOVEMBER 1972 TO AUGUST 1978
Complaints
Anaesthesia related
Headache
Vomiting
Pelvic pain
Backache
General pain
Headache
Incision related
Spotting/bleeding/serous discharge
Keloid formation/induration
Pain/tenderness/itching
Dizziness
Vomiting/nausea
Vaginal discharge/leucorrhoea
Frequent micturition
Other
TOTAL
Number
Percent
325
52
212
79
6
14
6.6
1.1
4.3
1.6
0.1
0.3
42
27
21
19
11
9
2
22
0.8
0.5
0.4
0.4
0.2
0.2
0.0
0.4
841
17.0
Because rural women in this area live in close proximity to their cattle in small
huts with walls that are covered with cow dung, tetanus toxoid is now being administered
routinely as a preventive health measure prior to camp surgery. In addition, women
who have had a home delivery or an abortion in the prior three weeks are no longer
accepted for camp sterilisation due to the high likelihood of infection. There has
been no mortality since these measures were implemented.
Gynaecological Abnormalities and Complaints
The incidence of gynaecological abnormalities was 2.7 percent at 6 months, 5.4 percent
at 12 months, 5.3 percent at 18 months and 2.9 percent at 24 months, The most frequently
reported condition was cervical erosion (1.6 percent at 24 months), Other conditions
reported were incisional hernia, keloid, cervicitis and vaginitis (Table IX).
The percentage of women reporting complaints at 6, 12, 18 and 24 months was 3.1, 7.9
7.4 and 5.0 respectively. Pelvic pain was the most frequently reported complaint (1.8
to 6.5%). However, it was mild in most cases, Wound pain was reported by 0.3 to 1.5
The other complaints were abdominal
percent of the women at long-term follow-up.
pain, weakness and depression (Table IX).
61
TABLE IX
GYNAECOLOGICAL ABNORMALITIES AND COMPLAINTS REPORTED FOR WOMEN UNDERGOING
STERILISATION IN SMALL CAMPS IN BARODA DISTRICT, NOVEMBER 1972 TO
AUGUST 1978
Gynaecological Abnormalities/
Complaints
6
N = 224
No.
%
Follow-up Visit (Months)
18
12
N = 243
N = 203
No.
%
No.
%
24
N = 617
No.
%
Gynaecological Abnormalities:
2
1
0
0
1
2
0
0
0
6
0.9
0.4
0.0
0.0
0.4
0.9
0.0
0.0
0.0
2.7
1
1
0
1
0
7
0
0
1
11
0.5
0.5
0.0
0.5
0.0
3.4
0.0
0.0
0.5
5.4
0
1
1
2
2
4
1
2
0
13
0.0
0.4
0.4
0.8
0.8
1.6
0.4
0.8
0.0
5.3
2
1
0
1
2
10
0
2
0
18
0.3
0.2
0.0
0.2
0.3
1.6
0.0
0.3
0.0
2.9
1
1
0.4
0.4
3
0
1.5
0.0
1
0
0.4
0.0
2
2
0.3
0.3
To tai
4
0
1
7
1.8
0.0
0.4
3.1
9
2
2
16
4.4
1.0
1.0
7.9
12
4
1
18
4.9
1.6
0.4
7.4
16
5
6
31
2.6
0.8
1.0
5.0
TOTAL
13
5.8
27
13.3
31
12.8
49
7.9
Incisional hernia
Keloid
Acute pelvic infection
Cervicitis
Tender/thickened adenexae
Cervical erosion
Cervical polyp
Vaginitis
Leucorrhoea
Total
Complaints:
Wound pain
Mild
Moderate
Pelvic pain
Mild
Modera te
Others
Gynaecological Surgery
In this series, 21 (3.4%) women underwent gynaecological surgery within two years of
of the sterilisation procedure. Dilatation and curettage (D&C) was performed in seven
(1.1%) cases.
Five women underwent D&C for treatment of menorrhagia and two for
dysfunctional uterine bleeding. Hysterectomy was performed in 7 (1.1%) cases, uterine
prolapse was the indication for hysterectomy in three and chronic cervicitis in two cases
Two women who had sterilisation failure underwent suction evacuation for pregnancy
termination. One woman underwent tubal reanastomosis because she lost both her sons.
(Table X).
62
TABLE X
POST-STERILISATION SURGERY REPORTED FOR 617 WOMEN UNDERGOING STERILISATION
IN SMALL CAMPS IN BARODA, NOVEMBER 1972 TO AUGUST 1978
Surgery After Sterilisation
Number
Percent
Dilatation and Curettage
For menorrhagia
For dysfunctional uterine bleeding
Unknown
Total
5
2
3
10
0.8
0.3
0.5
1.6
Hysterectomy
For uterine prolapse
For chronic cervicitis
For pelvic inflammatory disease
Unknown
Total
3
2
1
1
7
0.5
0.3
0.2
0.2
1.1
Suction evacuation for pregnancy
termination
Polypectomy
Tubal reanastamosis
2
1
1
0.3
0.2
0.2
21
3.4
TOTAL
Failure Rates
Three pregnancies were reported in this series. Thus the failure rate was 0.06
percent. In all three cases sterilisation was performed via the abdominal route
and the modified Pomeroy technique was used. In one case a 19 weeks pregnancy was
found 18 months after sterilisation. The woman decided to continue the pregnancy;
the husband agreed to undergo a vasectomy. Another woman who reported a 14 weeks
pregnancy 18 months after sterilisation underwent pregnancy termination. In the
third case an eight weeks pregnancy was reported two years after sterilisation.
This woman also underwent pregnancy termination.
63
DISCUSSION
In rural India today, the camp approach is being extensively used as a service delivery
mechanism because the existing medical infrastructure is inadequate for provinding
services to the extensive eligible population. Female sterilisation receives a well
deserved emphasis in the national programme since it is not only the most effective
method of fertility control for women who have completed their desired family size but
also offers significant programmatic advantages over other methods since potential
acceptors need to be motivated and medical staff and facilities mobilised on a one-time
basis only. To avoid the negative features of the mass camp approach, the present
trend is to provide female sterilisation services by organizing periodic, small camps.
This study was conducted to document the feasibility, safety, effectiveness and
acceptability of this service delivery approach utilizing available facilities and
personnel in existing rural health centres.
Sterilisation can have a major impact on fertility, Each voluntary sterilisation
operation is estimated to avert 1.5 to 2.5 births—a higher number than with the
continued use of any other method of fertility control (1,2). It is estimated that
if voluntary sterilisation were fully available in developing countries, it would
reduce the fertility of women over 30 years by about 25 percent, to approximately
the Japanese and Taiwanese level (3). The demographic impact of sterilisation
programmes depends upon the number of acceptors as well as their age and parity.
As younger couples with fewer children adopt sterilisation, the number of births
averted obviously increases.
Worldwide, the average woman obtaining sterilisation is in her early 30s (4). The
average number of living children for women adopting sterilisation varies widely in
different countries—from 2,6 in England to 8.7 in the Sudan (5,6). In Asian countries,
an average of five living children was reported (5,6,7). The mean age was 29.7 years
and the mean number of living children was 4.2 for 7,598 women undergoing sterilisation
in seven hospitals and three camp sites in India (10). In the present series, the
average woman undergoing sterilisation was younger (28.7 years) and had fewer living
children (3,6). Corresponding figures for age and parity were higher in earlier reports
from these camps (9,10). These findings indicate that younger women with fewer
children are now opting for sterilisation.
In the present series, more than half the women undergoing sterilisation, and more
than a fourth of their husbands were illiterate. Similar findings were reported in
another camp series in India (8). High illiteracy rates among female sterilisation
acceptors ranging from 47 to 186 percent have been reported from other developing
countries such as Bangladesh (11), Lebanon (13) and Iran (12). These data examplify
that education is not a determining factor for sterilisation acceptance among these
populations.
Studies from several developing countries reveal that a surprisingly large number of
women accepting sterilisation have never used contaaception before (4). In the present
study, also the vast majority of the women had not used any method prior to sterilisatioi
indicating that female sterilisation programmes are
reaching population who have
no access to family planning services and also that these women are more concerned
with limiting their family size than with spacing their births.
Mortality and morbidity rates following sterilisation are, understandably, of considerabi
concern in rural camp programmes. Complication rates following Pomeroy sterilisations
in various Indian reports range between 10.5 and 50.0 per 100 cases (14). The complica
tion rate was significantly lower for the present series and the vast majority of the
64
_ were not of- a serious
’
complications
nature.. The morbidity rates in this study were
lower than rates reported in other camps in India (15,16). Complication rates at
these camps have declined in recent years as evidenced by the comparatively higher
figures reported earlier (9,10). Since the last report (10) no further deaths have
occurred at these camps. Tnis lowering of morbidity and mortality is attributed to the
experience of the doctors with camp surgery and to the successful implementation of
prophylactic measures for combatting possible infection at camp settings. It is
interesting to note that lower morbidity rates were reported for women sterilised in
camps than for those sterilised at the Medical College Hospital in Baroda in
)
and pervious reports C^IO). This is probably due to the better preselection of
cases and, possibly a better response to prophylactic antibiotics at the camps as
hospitals generally harbour resistant strains of bacteria.
-- .
.
The reported failure rate among 2;
23,603 sterilisation
cases; in ten countries was 0.1
rates--ranged
0.1 to 0.4 percent
for Indian^studies
percent (18). Failure
-------«=>-- between
where the Pomeroy technique was used for tubal ligation (19,20,21). The failure rate
for the present series was lower.
lower. Although the follow-up rate in this study is
low, it is expected that if a woman suspects pregnancy following the sterilisation
operation she will report to the health centre. Intensive follow-up efforts are
presently underway as the authors propose to report the longterm sequelae, menstrua
pattern changes and failure rates for women sterilised at these camps.
Duration of hospital stay greatly contributes to the overall cost of services.
Hospital stay for the present series was considerable. To minimize this problem,
outpatient laparoscopic procedures have been initiated at these camp sites. Laparoscopic
camp programmes are gaining rapid momentum in the state of Gujarat. As many as.
one hundred laparoscopic sterilisations have been performed by the author (RB) in a
single day. Experience shows that patient acceptance is higher and morbidity significan y
lower when sterilisation is performed via laparoscopy than when it is performed via
minilaparotomy (22). For implementing large-scale programmes, the logistics of
providing laparoscopic equipment and training to local doctors in rural areas require
careful consideration.
The results of this study indicate that the small, periodic camp approach has been
shows
effective in providing female sterilisation services m rural areas.. Experience
1 x
that rural women accept these services readily. The visiting team is able to provide
training to the local doctors— several have been trained and arei now able to provide
sterilisation services at their health centres, Since
f---- the
-- number of women sterilised
at a single camp is limited, the usual activities of the health centre are not disrupted and postoperative care can be effectively provided by the local sta . It is
will -gradually be
expected that with continued efforts, a permanent infrastructure
---------developed for the delivery of sterilisation services in rural areas.
65
References
1. Lean, T.A. World movement towards the integration of voluntary sterilization and
health service programs. In: Schima, M.E. and Lubell, I., eds. New Advances in
Sterilization. The Third International Conference on Voluntary Sterilization,^
Tunis, Tunisia, February 1-4, 1976, New York, Association for Voluntary Sterilization.
168-173, 1976.
2. Lubell, I. and Frischer, R. Sterilization demand exceeds facilities.
World Population Fund Report, No. 3, Autumn-Winter, p 3-5, 1976.
Draper
3. Raverih.o'Ltj R.T. World epidemiology and potential fertility impact of voluntary
sterilization services. In: Schima, M.E. and Lubell, I., eds. New Advances in
Sterilization. The Third International Conference on Voluntary Sterilization,
Tunis, Tunisia, February 1-4, 1976. Association for Voluntary Sterilization,
p 23-32, 1976.
4. Green, P.C. Voluntary sterilization: Worldrs leading contraceptive method.
Population Reports, Special Topic Monographs, No. 2, p 51, 1978.
5, McCann, M.F. and Ferguson, J,G, Motivation of sterilization patients: Implications
for family planning education programs. Paper presented at the 9th International
Congress on Health Education, Ottawa, Canada, August 29 - September 3, 1976.
International Fertility Research Program, Female Sterilization Series No. 66, 1976,
6. Nahas, H.Z. Experience with vaginal sterilization in the Sudan: Tubal occlusion
via posterior colpotomy, a technique of female sterilization. In: Fathalla, M.F.,
Abdel-Latif, I.L. and El-Abd, M., eds. Voluntary Sterilization: Vol 3, reports,
from the Islamic world. Proceedings of the Second Conference on Voluntary Sterili
zation, Alexandria, Egypt, p 97-112, 1976.
7. Oblepias, V.R, The prospect of surgical sterilization in the Philippines. In:
Association for Voluntary Sterilization of the Republic of China,. Proceedings
of the Asian Regional Conference on 1Voluntary Sterilization, Tapei, Taiwan,
p 197-205, 1975,
8. Pachauri, S. A comparison of sociodemographic and fertility characteristics of
women sterilized in hospitals and camps. Int. J. Gynecol Obstet. 16: 132-136,
1978.
9. Bhatt, R.V., Patel, N.F. and Pachauri, S. Scope and limitations of camp approach
to female sterilization. The J. of Reprod. Med. 15: 103-108, 1975.
10. Bhatt, R.V., Pathak, N.D. and Chauhan, L.N. Female sterilization in small camp
setting in rural India. Studies in Family Planning, 9: 39-43, 1978.
11. Bangladesh, Government of. Summary of the evaluation study of the intensive
sterilization programme, p 29, 1977.
12. Kashani, H., McCann, M.F. and Vakilzadeh, J. Female sterilization at Farah Maternity
Hospital> Tehran, by colpotomy and other approaches. In: Fathalla, M.F., Abdel-Latif,
I.L. and. El-Abd, M., eds. Voluntary sterilization: Vol. 3, reports from the
Islamic World, Proceedings of the Second Conference on Voluntary Sterilization,
Alexandria, Egypt, p 151-172t 1976.
66
15. Mroueh, A. and Chamie, M. Social and psychological correlates and determinants
of female sterilization in Lebanon, 1974. In: Schima, M.E. and Lubell, I. eds.
Hew Advances in Sterilization. The Third International Conference on Voluntary
Sterilization, Tunis, Tunisia, February 1-4, 1976. Association for Voluntary
Sterilization, p 120-155, 1976.
14.
Omran, A.R. and K.F. Omran. Use-effectiveness,.safety, reversibility and
feasibility of female steirlization. World Health Organization Scientific
Group on the Assessment of the Relative Effectiveness, Safety and Acceptability
of Different Methods of Birth Control, Geneva, October 30-November 5, 1975.
15.
Pachauri, S. A clinical evaluation of 7,598 female sterilizations performed in
hospitals and camps in India. Proceedings of the Seventh Asian Congress of
Obstetrics and Gynaecology of the Asian Federation of Obstetrics and Gynaecology,
p 220-224, 1977.
16.
Parikh, M.N., Patel, D.N., Hussain, A. and Bhiwandiwalla, P. Laparoscopic sterili
sation in rural camps. Fifth Transaction of Scientific Papers, India Fertility
Research Programme, p 75-78, 1978.
17.
Bhatt, R.V.
18.
Presser, H.B. Voluntary sterilization: A world review.
Family Planning, No. 5, July 1970.
19.
Coyafi, B.F. Report on 2,847 sterilizations (Performed at the King Edward Memorial
Hospital, Poona). J. Obstet. Gynaec. of India, 14: 485-495, 1964.
20.
Adatia, M.D. and S.M. Adatia. A ten year study of sterilisation operaotons
(in Women). J. of Obstet. Gynaec. of India, 16: 425-426, 1966.
21.
Ghatikar, N.V. and Bhoopatkar, I. Aftermaths of puerperal sterilisation.
Obstet. Gynaec. of India^ 56: 572-578, 1966.
22.
Bhatt, R.V., Pachauri, S., Pathak, N.D. and John, E. A comparative study of the
tubal ring applied via minilaparotomy and laparoscopy in postabortion cases.
Int. J. Gynecol Obstet 16: 162-166, 1979.
Personal coimuntcattons.
Reports on Population/
J- of
67
QUINACRINE FOR FEMALE STERILISATION
R. Ananthakrishnan, MD, DGO, DFP1
Usha Krishna, MD, FICS, DGO 2
ABSTRACT
This is a report of a ten case study conducted to evaluate the safety and efficacy
of quinacrine hydrochloride solution for female sterilisation. The side effects
of the method are reported. Laparoscopy performed in five cases following sterili
sation showed successful tubal occlusion. The advantages and disadvantages of this
method of chemical sterilisation are discussed. The need to perfect this method
for delivering the chemical at the uterotubal junction is stressed and present methods
of chemical sterilisation are discussed.
INTRODUCTION
Although a wide range of new surgical methods for female sterilisation has been
developed in recent years, most available methods require a good operating theatre
and well trained medical personnel. Efforts are, therefore, being made to search
for a method which could be a quick*outdoor procedure requiring minimal equipment
and training of personnel. Chemical sterilisation has the potential for fulfilling
these criteria. As this method is not reversible, it is more suitable for women
who have three or more living children. It could, therefore, be a valuable addition
to the presently available methods in India where there are large numbers of such
women. This paper reports the results of a study conducted to evaluate the safety
and efficacy of the intrauterine instillation of quinacrine hydrochloride solution
for female sterilisation
MATERIALS AND METHODS
Ten women .who were 25 to 40 years of age and had three or more healthy^ living children
were included in this study which was conducted at the KEM Hospital in Bombay. The
procedure was performed in the early part of the proliferative phase of the menstrual
cycle by the intrauterine instillation of 1.5 gms of quinacrine hydrochloride suspended
in 7 ml of distilled water. The chemical was instilled through a Foley’s catheter
which prevented the reflux of the chemical. The study protocol required that the
procedure be repeated for three successive cycles. However, in this series three
women returned for the second instillation and only two returned for the third
instillation. To prevent conception between instillations, 50 mgm of Depoprovera
was administered intramuscularly once in three months for a period of six months.
1
2
Research Officer, Honorary Associate Professor, Department of Obstetrics and
Gynaecology, KEM Hospital, Bombay.
68
RESULTS
Side Effects
In this series, mild abdominal discomfort, nausea, vomiting, giddiness and bleeding
were reported in 4 (40.0%) cases after the first instillation of quinacrine hydro
chloride. One woman collapsed after the first instillation but recovered following
immediate resuscitation and was in good condition when she was discharged after three
days of hospitalisation. Another woman developed an allergic rash all over the body
three days after the second instillation.
Laparoscopic Findings
Laparoscopy was performed in five cases following chemical sterilisation. Three of
these women had undergone three instillations and two had undergone only two instil
lations of quinacrine hydrochloride. In all five cases the uterus was found to be
normal. The tubes were blocked and appeared somewhat thinner and whitish in colour
along their entire length. No intraperitoneal or peritubal adhesions were seen
DISCUSSION
Various chemical agents have been tried for occluding the Fallopian tubes. Gelatinresorcinol formaldehyde (GRF) tried by Falb et al is an adhesive which is instilled
by a balloon-tipped cannula (1). As this chemical provokes tissue growth, it is
essential to deliver it at the cornual ends of the tubes. GRF has a two-part
formulation; the gelatin resorcinol is not mixed with formaldehyde until immediately
before administration because the material undergoes rapid solidification. The
procedure requires an inbuilt mixing apparatus to ensure that the chemical is delivered
at the uterotubal junction and is, therefore, a complicated one.
Methyl cyano-acrylate (MCA)f another agent used for tubal oc.clusion polymerizes on
contact with moist biologic tissues. Although it flows easily into the Fallopian
tube it does not spill into the peritoneal cavity as polymerization stops its flow.
Stevenson reported tubal occlusion in 70.0 percent cases after a single instillation
of MCA through a balloon catheter and no recanalisations were reported during three
years follow-up (2). In using MCA it is necessary to prevent its contact with any
tissue in the genital tract except the Fallopian tubes. As proliferating endometrium
acts as a valve and closes the tubal ostia against the rise in intrauterine pressure,
the instillation of MCA is confined to the time when the endometrium is thin as after
menstruation or prolonged oral contraceptive therapy.
Caustic solutions such as zinc chloride, phenol and sodium morrhuate can also produce
occlusion of the tubes but they are not used in practice as peritoneal spillage of
these agents causes chemical peritonitis.
Quinacrine hydrochloride was first tried by Zipper who used quinacrine suspension
with xylocaine. The chemical was instilled through a Kahn’s cannula and an occlusion
rate of 80.0 percent was reported after three instillations (3). Davidson reported
a success rate of 60.0 percent three to four months after a single instillation
through a plastic cannula. He felt the prevention of cervical reflux during the
procedure allowed the chemical to enter both the uterotubal junctions and better
results were achieved (4).
69
While a hysteroscope is required for the delivery of both GRF and MCA at the cornual
ends of the tubes, quinacrine has an advantage in that it can be instilled into the
uterus through a catheter. However, it also has certain drawbacks. As more than
one instillation is required to produce tubal occlusion, the failure rate is high
because women may not return for the second and third instillations, In such cases,
Failure to use contrapartial occlusion of the tubes is an additional sequel,
ceptives between instillations can result in intrauterine or ectopic pregnancy.
Intravasation, postinstillation shock and excitation of the central nervous system
are other undesirable side effects.
To minimize these problems, sterilisation by quinacrine pellets is being tried—
pellets enable a slow release of the chemical and thereby bring it into prolonged
contact with the tubal area, Zipper showed encouraging results after six months
follow-up of his series of 139 cases (3).
Another method of delivering quinacrine at the tubal ostea is by inserting a Copper T
IUD with quinacrine applied at the two tips of its transverse limb, A pilot study
of the quinacrine IUD is presently underway at our institution, The Copper T IUD
acts as a carrier for the chemical and also as a contraceptive, Histopathological
examinations will be conducted to evaluate tubal occlusion following hysterectomy.
Chemical sterilisation with quinacrine hydfochloride has considerable scope for
developing countries. However, a practical method needs to be developed for the
effective delivery of this chemical at the uterotubal junction to enable widespread
use of this technique. Research is presently underway to perfect this technique.
ACKNOWLEDGEMENT
The authors thank Dr. C.K. Deshpande, Dean and Dr. V.N. Purandare, Head, Department
of Obstetrics and Gynaecology for permission to publish the hospital data. The author
also acknowledges the assistance provided by the International Fertility Research
Program for sponsoring this collaborative study.
References
1. Falb, R.^ LowerB.R., Crowleys J.P. and Powell3 T.R. Transcervical fallopian
tube blockage with gelatin-resorcinol formaldehyde (GRF).In:Advances in Female
Sterilization Techniques: Eds. J. Sciarra, W. Droegmueller and J. Speidel.
Harper and Row3 p 208-2153 1976.
2. Stevenson, R.C. Methyl Cyano-Aerylate (MCA) for tubal occlusion. In: Advances
in Female Sterilization Techniques. Eds. J. Sciarra, W. Droegmueller and J. Spiedel.
Harper and Row, p 216-224, 1976.
3. Zipperj J.3 Rivera^ M.3 Cole3 R. et al. Quinacrine hydrochloride pellets. A
non-surgical method of female sterilization. International Fertility Research
Program publication .
4. Davidson, O'.W and Wilkins, C. Chemically induced tubal occlusion in the human
female following a single instillation of quinacrine. Contraception, Vol. ?s
No. 4, p 333, 1973.
70
FACTORS INFLUENCING A WOMAN’S DECISION TO UNDERGO STERILISATION
- A CAMP STUDY
R. V. Bhatt9 MB, DCH
7
Armin Jainshedji, MA 2
ABSTRACT
This paper analyses the sociodemographic characteristics, fertility patterns,
previous contraceptive experience and reasons for adopting sterilisation as a
method of fertility control by 4,948 women who underwent sterilisation at camps
in Baroda District. In this series, the average woman seeking sterilisation
was 28.7 years of age,had 2.5 years of formal education and had not used
contraception prior to undergoing sterilisation. Most (64.2Z) of the women had
3 to 4 living children; 22.0 percent had 5 or more living children. There was
a marked preference for male offsprings. The child loss rate was 83.6 per 1000
live births. In a fourth of the cases the husband was the main person who
influenced the woman to undergo sterilisation and was also the referral source.
Unreliability (45.0%), side-effects (36.1%) and inconvenience (18.9%) of other
methods were reasons given for preferring sterilisation to other methods of fertility
control.
INTRODUCTION
In India, sterilisation camps in rural areas have gained considerable momentum
during the past few years. These camps are sporadic and offer limited follow-up
care. Despite this, female sterilisation is highly acceptable to rural women
mainly because of non-availability of other effective fertility control methods.
Voluntary sterilisation offers considerable programmatic advantages as it is a
cost-effective, one-time method which does not require continued supervision.
It does, however, necessitate contacting the potential acceptor when her motivation
is at its maximal threshold. To accomplish this effectively, it is important
to understand the factors which effect the woman’s decision to adopt sterilisation.
This paper analyses the sociodemographic and fertility characteristics and previous
contraceptive experience of women undergoing sterilisation in camps and evaluates
reasons for adopting sterilisation as a method of fertility control.
MATERIALS AND METHODS
Data on 4,948 women undergoing sterilisation from November 1972 to August 1978
at bi-weekly, small camps in the Baroda District of Gujarat are reported. These
camps were organized by visiting teams from the Department of Obstetrics and
Gynaecology of the Baroda Medical College Hospital.
^Professor and Head, Department of Obstetrics and Gynaecology, Baroda Medical College,
Baroda.
^Research Assistant, India Fertility Research Progarmme, Hyderabad.
71
Definitions and Criteria
Data were recorded on standard forms of the India Fertility Research Programme
using standard definitions and criteria. Only women undergoing sterilisation
for family size limitation were included in the study. Prior abortion,
stillbirth and live birth rates are expressed per 1000 pregnancies, Rates for
living children and child loss are expressed per 1000 live births, Child loss
includes neonatal, infant and child mortality, Child loss-parity ratio is
calculated per 1000 live births and sex ratio is the number of males per 100
females.
RESULTS
Age and Parity
In this series, women seeking sterilisation were in their late 20s; their mean
age was 28.7 years, The majority of the women (76.2%) were between 25 to 34
_
Mean parity (live births) was 4.0. While 58.6 percent of the
years of age.
women had 3 to 4 live births, 14.3 percent had more than 5 live births (Table I).
Figure 1 shows an increase in parity from 2.0 at < 19 years of age to 6.0
at 45+ years of age.
Employment and Education
The vast majority (98.4%) of the women in this study were not gainfully employed
(Table I). More than half of the sterilisation adopters (56.6%) had no formal
education. While 12.4 percent had attended school for 7-9 years> only 56 percent
had completed school or had been to college, Their husbands had attained higher
educational status. While 25.7 percent of the husbands had completed 4 to 6
years of school education; 19.8 percent had completed high school or had attended
college. Only 26.8 percent of the husbands were illiterate (Table I).
Marital Status, Religion and Residence
Only eight (0.2%) women in this series were not currently married. The majority
(89.8%) were Hindu, 9.7 percent were Muslim and 0.4 percent were Christian.
Most (66.6%) of the women were from rural areas (Table I).
Previous Pregnancy Outcome
The women in this series experienced a total of 18,878 pregnancies prior to
sterilisation. The live birth rate for the series was 967.8 per 1000 pregnancies.
The spontaneous and induced abortion rates per 1000 pregnancies were 25.4 and 1.4
respectively. The stillbirth rate was 5.4 per 1000 pregnancies (Table II). The
percentage of women reporting one or more spontaneous and induced abortion was
7.7 and 8.6 respectively.
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 4,948 WOMEN UNDERGOING CAMP STERILISATION
IN BARODA DISTRICT, BARODA, NOVEMBER 1972 TO AUGUST 1978
Number
Percent
Age(Years)
< 24
25 - 29
30 - 34
35 - 39
40 +
Mean
591
2108
1664
495
90
12.0
42.6
33.6
10.0
1.8
Live births
<2
3
4
5
6
7+
Unknown
Mean
560
1509
1391
771
415
294
8
Patient’s Education (School years)
0
1-3
4-6
7-9
10 - 12
13 +
Mean
2802
413
839
615
263
16
Husband’s Education* (School years)
0
1 - 3
4-6
7-9
10 - 12
13 +
Mean
1323
499
1269
870
844
135
Gainfully Employed
No
Yes
Unknown
4871
76
1
98.4
1.5
0.0
Religion
Hindu
Muslim
Christian
Other
4445
481
21
1
89.8
9.7
0.4
0.0
3294
1652
2
66.6
33.4
0.0
Sociodemographic Characteristics
Residence
Rural
Urban
Unknown
__
*For currently married women only.
28.7
11.3
30.5
28.1
15.6
8.4
5.9
0.2
4.0
56.6
8.3
17.0
12.4
5.3
0.3
2.5
26.8
10.1
25.7
17.6
17.1
2.7
5.0
73
The induced abortion rates were 25.4 per 1000 pregnancies at <25 years,
18.3 at 25-34 years and 31.6 at 34+ years of age. The spontaneous abortion
rate increased with increasing age from 20.0 per 1000 pregnancies at < 25 years
to 29.5 per 1000 pregnancies at 34+ years of age. There was an increase in
the stillbirth rate from 4.3 at < 25 years to 5.6 at 25 - 34 years, and a
slight decrease to 5.5 in older women per 1000 pregnancies (Fig 2).
Living Children and Child Loss
Most (64.2%) of the women had 3 to 4 living children; 22.0 percent had 5> or more
age of the youngest child was between 1 and 2 years for
living children. The
r
77.4 percent of the women, Only one woman had a child who was less than one
year of age (Table III).
TABLE III
NUMBER OF LIVING CHILDREN AND AGE OF THE YOUNGEST CHILD REPORTED
BY 4,948 WOMEN UNDERGOING CAMP STERILISATION IN BARODA DISTRICT,
BARODA, NOVEMBER 1972 TO AUGUST 1978
Number
Percent
Living Children
0
1-2
3-4
5-6
7 +
Unknown
Mean
1
678
3177
956
136
7
0.0
13.7
64.2
19.3
2.7
0.1
Age of Youngest Child
< 1
1- 2
2- 3
3- 4
4- 7
7 +
Unknown
Mean
1
3829
382
363
275
91
7
Living Children and Age of the
Youngest Child
3.7
0.0
77.4
7.7
7.3
5.6
1.8
0.1
2.0
The sex ratio for live births was 142.0 (Table IV). Women with 2 to 4 living
children had more males than females, However, women with one living child
had more females than males (Fig 3).
74
6.0
■w'
d
50
3.0
c
d
£
0
|
<19
|
-24
|
-29
|
-39
|
-34
|
-45+
|
-44
Maternal Age
Fig 1
MATERNAL AGE BY PARITY FOR 4,948 WOMEN UNDERGOING CAMP STERILISATION
IN BARODA DISTRICT, BARODA, NOVEMBER 1972 TO AUGUST 1978
TABLE II
PREVIOUS PREGNANCY OUTCOME FOR 4,948 WOMEN UNDERGOING CAMP STERILISATION
IN BARODA DISTRICT, BARODA, NOVEMBER 1972 TO AUGUST
1978
Pregnancy Outcome
Number
Rate/1000
Live birth
Spontaneous abortion
Induced abortion
Stillbirth
18271
479
26
102
967.8
25.4
1.4
5.4
18878
3815.3*
Total
Note: The live birth, abortion and stillbirth rates are based on the number
of pregnancies.
* This rate is based on the number of women.
Stillbirth
Spontaneous Abortion
Induced Abortion
6.0
30.0
40.0
29.5
25.0
w
0)
o
a
aS 20.0
c60
24.2
25.4
4.5
20.0
20.0
o
o
o
0)
0
Ln
18.3
OJ
J-4
P-i
05
« 5.5
i
■
i
<25
25-34
34+
15.0
1
■
_L
<25
25-34
34+
Maternal Age
3 .0
1
I
1
<25
25-34
34+
(Years)
Fig 2
PKEGNAWY WASTAGE BY
?“aSS™C1™
1972 TO AUGUST 1978
STERILISATION IN BARODA DISTRICT,
76
The child loss rate for the series was 83.6 per 1000 live births (Table IV)
Child loss rates increased sharply with increasing maternal age (Fig 4).
The child loss-parity ratio increased with increasing parity. The increase
was very marked after parity 4—from 35.9 for parity 3 - 4 to 106.7 for parity
5-6 and 211.8 for parity 7+ (Fig 5).
Previous Contraceptive Practice
Prior to sterilisation, the majority (98.6%) of the women did not use any
contraceptive method. The condom and IUD were each used by 0.5 percent of
the women. Five women (0.1%) and four (0.1%) men had undergone sterilisation
previously (Table V).
50.0
49.5
Male
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o
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laaaaai
c--oaai
1
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i
■
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i
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I
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l
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i
i
i
i
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0
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i
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aayaa
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25.3
!■■■■■<
iaaa>«H
laaaaai
■ aaena
■ (■■■
loaaaa
!■■■■■
■ ■■■■
iaaaaa
■ ■■■■
iaaaaa
iaaaaa
iaaaaa
iaaaaa
iaaaaa
iaaaaa
iaaaaa
iaaaaa
iaaaaa
iaaaaa
iaaaaa
aaeea
aaaaa
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16.8
nmn
•■tin
ia(SI(l
■••■■I
■■•■■I
■■■•■I
10.3
aaaaei
■■■■■<
•■■■■I
4.0
■■■■■<
■■■■•■
■■■■■J
2
3
I■■■ ■■
i •n■a<■
!■•■■■■
!■■■■■■
!■■■■■■
iaaaaaj
4+
Living Children
Fig 3
NUMBER OF LIVING CHILDREN BY SEX FOR 4,948 WOMEN UNDERGOING CAMP
STERILISATION IN BARODA DISTRICT, BARODA, NOVEMBER 1972
TO AUGUST 1978
77
110.0
107.7
co
x:
■u
43
0)
>
’hJ
O
O
O
70.6
u 70.0
d
0^
w
co
o
o
30.0
<25
25-34
34+
Maternal Age (Years)
Fig 4
MATERNAL AGE BY CHILD LOSS REPORTED FOR 4,948 WOMEN
UNDERGOING CAMP STERILISATION IN BARODA DISTRICT,
BARODA, NOVEMBER 1972 TO AUGUST 1978
TABLE IV
OUTCOME OF LIVE BIRTHS REPORTED FOR 4,948 WOMEN UNDERGOING CAMP
STERILISATION IN BARODA DISTRICT, BARODA, NOVEMBER 1972 TO
AUGUST 1978
Number
Rate/1000
Living children
Male
Female
Sex ratio
16744
9832
6912
916.4
538.1
378.3
Child loss
1527
83.6
Total
18271
967.8*
Outcome
142.0
Note: The rates for living children and child loss are based on the
number of live births.
Sex ratio is the number of males per 100 females.
*
This rate is based on the number of pregnancies.
78
220
211.8
o
■u
&
qj
PP
I
110
106.7
w
w
o
32
O
6.3
0
1-2
3-4
5-6
7+
Parity
Fig 5
CHILD LOSS-PARITY RATIO BY PARITY FOR 4,948 WOMEN
UNDERGOING CAMP STERILISATION IN BARODA DISTRICT,
BARODA, NOVEMBER 1972 TO AUGUST 1978
TABLE V
PREVIOUS CONTRACEPTIVE METHOD USED BY 4,948 WOMEN UNDERGOING CAMP
STERILISATION IN BARODA DISTRICT, BARODA, NOVEMBER 1972 TO
AUGUST 1978
Contraceptive Method
Numb er
Percent
None
IUD
Condom
Orals
Tubectomy
Vasectomy
Rhythm/withdrawl
4877
27
26
6
5
4
3
98.6
0.5
0.5
0.1
0.1
0.1
0.1
79
Percent Cases
UJ
Ln
o
o
T
>
n
H
O
——
HI
(Z>
T
O'
o
Hi
HI
21
Hl
Husband
c
m
3
n
r*
a
w
21
n
p’
OQ
21
Q
(D
cn
H
M
cn
o
3
w
U Hl
co
I
hi r*
cn hi
H cn
>
n hi
Hl H
Self
Ln
O
Friends/relatives
cyi
w u
> M
n
O Hl
Q cn
> Hl
- O
21
21
O Hj
< O
W
□>
’-d
rd >— 00
>0
Ln
(D
t-h
(D
i-i
Husband
U3
OQ
co
cn
o
c
o
a>
-o s:
bo O
Self
to
m
s
H td
o
Family Planning/health staff
> C3
c3 21
Q O
a w
Cd >0
H Q
O
co 2
-o O
CO
n
I
cn
H
M
>0
H
Hl
CO
>
H
Hl
o
HI
21
w
>
o
u
>
m
pj
co
CO o
rt 3
CD
H Hi
H- O
H* H
co hd
h
■■■■■■■■■■■■■■■■•■■■■■■■■■■■■■■■■i
■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■i
ESS!!!!!!!!!!!!!!!!?!■■■■■■■■•■■■j q
g£2g!2!22:::2H£iggZSU222:g!:gggl
■■■■■■■■■■■■■■■■■■■■■■■■■■I
•■■■■■■■■■■••■■■■■■■■■■■■■I
■■■■■■■■■■■■■■■■■■■■■■■■■■I
n>
H- Hi
O (0
3 H
H
H3
GQ
CO
O>
Other methods
unreliable
Side-effects of
other methods
■ ■■■■■■■■!■■■■ H*
■ ■■■■■■■■■■■■■fl oo
!■■■■■■■■■■■■■
■■■■■■■■■■■■■4*
!!!S!”Z2!!!!3<o
Inconvenience of other methods
80
The Sterilisation Decision
In 60 9 percent of the cases, the husband was the main person who influenced the
woman’in her decision to undergo sterilisation; 38.5 percent of the women were
themselves responsible for this decision. In 61.5 percent cases, the husband
was the referral source. A third of the women went on their own for sterilisation.
Only 5.9 percent were referred by family planning or health staff. Forty five
percent of the women found other fertility control methods unreliable and so
preferred to undergo sterilisation. Side-effects (36.1%) and inconvenience (18.9Z)
of other methods were other reasons given for preferring sterilisation (Fig 6).
DISCUSSION
Sterilisation in rural camps is becoming increasing popular, in India. During
1977—78, when there was a general slump in sterilisation programmes, 52.4
percent of the sterilisations were performed in rural areas (1). By 1978
a total of 28.1 million sterilisations were performed,in India?of which about
30 percent were female sterilisations(1). However, for the sterilisation
programme to have a demographic impact—to bring down the crude birth rate
to 30 by 1983—an annual average of 3.5 to 4 million sterilisation procedures
must be performed and another 4 million couples must be protected by other
contraceptive methods (2).
Age,parity and sex of living children are some of the important variables that
older the woman and the more the number of
determine sterilisation acceptance. 'The
-- ----children she has, the higher*is the likelihood of her accepting sterilisation, In this
_'..j women were below 30 years of age. World-wide,
analysis, 54.6 percent of the
sterilisation
is in her early 30s (3) . In India, 43.4
the average woman seeking l
—
percent of tubectomy acceptors in 1976-77 were below this age (1). This indicates
family
that the Indian .woman achieves her <desired
.---. size earlier ,than her counterpart
in many other countries. Among female sterilisation acceptors m different
countries, a wide range in the average number of living children is documented
(4-9). In a pooled analysis of 2,802 female sterilisations in India, the average
number of living children was 3.7 (10). In the present analysis also the mean number
of living children was 3.7. The age of the youngest child was a c^cial factor
for female sterilisation adopters in El Salvador, England and the Philippines (11).
The mean age of the youngest child ranged from 2.8 in the Philippines to 4.9 in
England (11). In the present series, it was lower (2.0). Findings related to
the number of living children and the age of the youngest child suggest that
most of the women in this series were eager to limit their family size. These
women had, in all probability,been potential acceptors for some time. Preferrenc
for male offsprings is most commonly the cause for an increase in ami y
Several researchers have noted that most sterilisation adopters have at least
one male child (12-15). This analysis also shows a m^rked Preferrence for sons.
This and other studies (9-12, 16,17)_ show that education is not a
8
factor for sterilisation acceptance. In this study, religion also did not
appear to be an important de terminent.
81
The decision to undergo sterilisation is a very complex one. The interaction of
several variables motivate the individual to decide to undergo sterilisation. This
study indicates that about 61 percent of the women were influenced by their husbands.
This finding is not surprising as a typical Indian woman plays a secondary role m
the household. Ferguson and McCann (11) reported that more highly educated women
consider themselves more responsible for undertaking the sterilisation decision.
In this series, the majority of the women were uneducated and were, therefore, more
likely to be influenced by their husbands. The results of this study focus on the
need to concentrate efforts on motivating the husband whose attitude is critical
in the decision- making processes. However, to achieve long-term gams, health
education of the woman is of considerable importance. In Bangladesh, Chile, Mexico
and the Philippines, seventy percent or more of the sterilisation adopters were
referred by family planning or health staff (4, 12, 18, IS).In this series, most of
the women were referred for sterilisation by their husbands. Efforts to promote
sterilisation through family planning and health staff should be intensified.
In this series, unreliability and side effects of other contraceptive methods
were reasons given by most of the women for preferring sterilisation. In the
Philippines, El Salvador and England also there was an over-riding concern with
side effects associated with other contraceptive methods; unreliability of other
methods was another reason for preferring sterilisation (11). In a study of 2,802
cases in India, inconvenience of other methods was the primary reason given by more
than half of the study group (10). A vast majority of the women in the present
series had not used contraception before. This finding is common to several studies
from developing countries (12,18,20). Female sterilisation appears to be a preferred
method for limitation of family si&e in rural areas in India.
References
Welfare Programme in India.
Iear -------Book 1977-78. Government
of India
3nil,*
1. Family
V UJU tz
rr o tzj ux o j- j.
■
-ir.
in
Ministry of Health and Family Welfare, Department of Famzly Welfare, New Delhv.
2. Nortman, D.L. Indiats new birth rate target: An analysis.
Development Review, 4: 277-312, 1978.
Population and.
Voluntary sterilization: World1s leading contraceptive method.
Population Reports, 2: M-37 - M-71, March 1978.
3. Green, C.P.
4. McCann, M.F. and Ferguson, J.G. Motivation
i--------------- of sterilization .patients: Implications
for family planning education programmes. Presented at the 9th Intematzonal
Congress on Health Education, Ottawa, Canada, August 29-September 3, 1976.
5. Nahas, H.Z. Experience with vaginal sterilization in the Sudan. Tubal occlusion
via posterior colpotomy, a technique of female sterilization. In: Fathalla, M.F.
Abdel-Latif, I.L. and El-Abd, M. eds. Voluntary sterilization. Vol 3, reports
from the Islamic world. Proceedings of the Second Conference on Voluntary
Sterilization, Alexandria, Egypt, p 97-112, 1976.
sterilization- in
6. OblepiaSj V.R. The prospect of surgical
-------------------------- t the Philippines.
t
--•
”
•* ** * of Chz-na. Proceedings
In: Association for Voluntary Sterilization
of- the Republic
of the Asian Regional Conference on 1Voluntary Sterilization, Taipei, Taiwan,
p 197-205, 1975.
.*
82
7. Tsuei^ J. J. Female sterilization: Postpar turn and intrapartum programme- Acceptability
effectiveness3 technology and complications.. In: International Planned Parenthood
Federation/South-East Asia and Oceania Region. Seminar on Voluntary Sterilization
and Post-contraceptive Regulation, p 58-70, 1975.
8. Presser, H.B. Voluntary sterilization: A world review.
Family Planning, No. 5, p 1-36, 1970.
Reports on Population/
9. Pachaurij S. A comparison of sociodemographic and fertility characteristics
of women sterilized in hospitals and camps. Int. J, Gynecol. Obstet. 16: 132-136>
1978.
10. Jamshedji, A. and Pachaurz, S. The sterilisation decision - A sociodemographzc
and fertility profile of the Indian woman. Accepted for publication zn the Journal
of Family Welfare, Family Planning Association of India.
11. Ferguson, J.G. and McCann, M.F. Toward an understanding of the decision to
accept sterilization. Presented at the 84th Annual Convention, American Psycho
logical Association, Washington, D.S» September 3-7, 1976.
12. Bangladesh, Government of. Summary of the evaluation study of the intensive
sterilization programme, 1977.
A 1975 worua
world review.
13. Bernard, R.P. Fertility accounting at female sterilization: a
Presented at the Second Conference on Voluntary Sterilization, Egyptian Fertility
Control Society, Alexandria, Egypt, June 18-20, 1975.
14. Miller, R., Joshi, P.C., Giri, K. and Tulachan,^ S.S. Laparoscopic sterilization
in camp settings: The Nepal experience. Washington, D.C. USA. Agency for
International Development, Office of Population, p 30, September 1974.
15. Trias, M. General comments on Profamilia's voluntary sterilization programs.
In: Sanhueza, H. and Jaimes, P. eds. Contraceptive Progress in Latin Amerzca
and the Carribbean. Proceedings of the IPPF/WHB Second Regional Semvnar, Medellin,
Colombia, New York, International Planned Parenthood Federation/Western Hemtsphere
Region, p 75-77, 1976.
16. Mroueh, A. and Charnie, M. Social and psychological correlates and determinents
°f female sterilization in Lebanon, 1974. In: Schima, M. and Lubell, I. eds.
New Advances in Sterilization. The Third International Conference on Voluntary
Sterilization, Tunis, Tunisia, February 1-4, 1976, p 120-135, 1976.
17. Kashani, H., McCann, M.F. and Vakilzadeh, J. Female sterilization at
Maternity Hospital, Tehran, by colpotomy and other approaches. In: Fathalla, M.F.,
Abdel-Latif, I.L. and El-Abd, M. eds. Voluntary Sterilization, Vol 3, reports
from the Islamic World. Proceedings of the Second Conference on Voluntary SterzLzzation, Alexandria, Egypt, p 151-172, 1976.
18. Gracia, R.F J? .and Ha Crtiz, R.A. Psycho-socio-biological factors influencing
acceptance of voluntary sterilization. In: Schima, M. and Lubell, I. eds. New
Advances in Sterilization. The Third International Conference on Voluntary
Sterilization, Tunis, Tunisia, February 1-4, 1976, p 136-146, 1976.
83
19. Herrera, M.M.y Wells, M.W., Araneda, G.L, and Moncada, M. Female sterilization
Retrospective and prospective evaluation in the central areas of Santiago, Chile^
Revista Chilena de Obstetricia y Ginecologia, 40(2): 61-71, 1975,
20. Fongsu, A. Characteristics and recovery times of 226 women undergoing interval
sterilization by the suprapubic "minilap” technic at the Chiang Mai Christian
Clinic, Chiang.Mai, Thailand: A preliminary report. In: Association for Voluntary
Sterilization of the Republic of China (Taiwan). Proceedings of the Asian Regional
Conference on Voluntary Sterilization, Taipei, Taiwan, p 129-133, 1975,
84
LAPAROSCOPIC STERILISATION WITH ELECTROCOAGULATION
PRIOR TO PREGNANCY TERMINATION
Padma Rao> MD^
S. Basu, MPH2
ABSTRACT
This study was conducted to evaluate the safety and technical ease of performance of
sterilisation by laparoscopic electrocoagulation when performed immediately prior to
first trimester pregnancy termination. Three hundred procedures performed at the
Kasturba Medical College Hospital, Manipal are reported. The results of this study
showed that preabortion sterilisation by laparoscopic electrocoagulation did not
increase the incidence of postoperative complications. However, this procedure was
not technically easier than postabortion sterilisation as was originally hypothesized.
For making scientific comparisons between preabortion and postabortion sterilisation
procedures, controlled, random, comparative studies are needed.
INTRODUCTION
The high acceptance of fertility control methods after termination of pregnancy has
been extensively documented (1-5). A woman who has completed her desired family
size is readily motivated to undergo sterilisation when she requests termination
of an unwanted pregnancy. Studies show that postabortion sterilisation is a safe
and effective procedure (6-9). Sterilisation in the immediate postabortion period
has, therefore, been performed extensively both in developed and developing countries.
There are, however, numerous reported instances of women who agree to undergo sterili
sation but change their mind after pregnancy is terminated. These women could be
saved from the risk of yet another unwanted pregnancy if the sterilisation procedure
is performed prior to the pregnany termination procedure. Such reversal may also make
the sterilisation procedure technically easier since the Fallopian tubes are more
readily identified when the uterus is enlarged. This study was undertaken to evaluate
the safety and technical ease of performance of sterilisation by laparoscopic electro
coagulation when performed immediately prior to first trimester pregnancy termination.
MATIERIALS AND METHODS
From August 1975 to April 1979, 300 women underwent laparoscopic sterilisation by the
electrocoagulation technique immediately prior to first trimester pregnancy termination
at the Kasturba Medical College Hospital in Manipal.
Data Collection
Data on sociodemographic and reproductive characteristics of the study subjects and
clinical aspects of the procedure were recorded on standard forms of the India
Fertility Research Programme. All 300 study subjects returned for history and physical
examination at the follow-up visits which was scheduled 7 to 21 days after surgery.
■^Professor and Head, Department of Obstetrics and Gynaecology, Kasturba Medical
College Hospital, Manipal.
2Study Coordinator, India Fertility Research Programme, Calcutta.
85
Definitions and Criteria
Only women requesting sterilisation for family size limitation and concurrent termination
of pregnancy of six to twelve weeks’ gestation were included in the study. Surgical time
was defined as the time from the initial incision to final closure. A technical
failure was defined as a case in which the designated procedure could not be completed.
Technical difficulty was defined as any difficulty associated with the equipment.
Surgical difficulty was any difficulty encountered during the procedure which was
not due to equipment-related problems.
Complications and complaints due to the sterilisation procedure was categorized as
operative, immediate and early postoperative. Operative and inu-ediate postoperative
complications and complaints were those occurring during surgery and prior to discharge
from the hospital. Early postoperative complications and complaints were those reported
at the follow-up visit.
Surgical Procedure
An hour and a half before surgery,the patient received one 50 mg largactil tablet
and one 25 mg phenergan tablet along with an intramuscular injection of 100 mgm
of pethidine. Local anaesthesia was provided by infiltrating 15 to 20 ml of one
percent xylocaine. The sterilisation procedure was performed using the standard
laparoscopic electrocoagulation technique. Pregnancy termination by vacuum aspiration
was performed while the patient was still under the effect of premedication. Prophy
lactic antibiotics were not administered routinely. However, analgesics were given
for three days and ferrous sulphate and vitamin C were prescribed for one month.
RESULTS
Sociodemographic Characteristics
The mean age of the women in this study group was 32.4 years; 30.7 percent of the
women were below 30 years of age. Their mean parity was 4.6; 11.7 percent had one
to two live births and 16.6 percent had seven or more live births. The mean number
of living children was 4.5; 73.3 percent of the women had three to six living children.
The majority of the women were from rural areas (71.4%) and were not gainfully employed
(82.3%). The: mean level of education of these women was 4.8 and that of their
husbands was 6.8 school years (Table I).
In this series, 21.0 percent of the women gave a history of one or more spontaneous
abortions .and 5.6 percent reported having had one or two induced abortions (Table I).
While the majority (84.3%) of the couples in the study group had not used any method
of contraception during the three months prior to the present conception, 6.0 percent
had used IUDs, 5.7 percent were on oral contraceptives and 3.3 percent had used the
condom (Table I).
Period of Gestation
About a third of the pregnancies were terminated at six to seven weeks1 gestation,
62.3 percent were terminated at eight to ten weeks1 gestation and only 5.7 percent
were terminated at eleven to twelve weeks1 gestation.
86
TABLE I
SELECTED SOCIODEMOGRAPHIC CHARACTERISTICS OF 300 WOMEN UNDERGOING LAPAROSCOPIC
STERILISATION PRIOR TO PREGNANCY TERMINATION AT THE KASTURBA MEDICAL COLLEGE
HOSPITAL, MANIPAL, AUGUST 1975 TO APRIL 1979
Sociodemographic Characteristics
Number
Percent
14
78
102
71
35
4.7
26.0
34.0
23.7
11.6
Age (Years)
20
24
25
29
30 - 34
35 - 39
40 +
Mean
32.4
Parity
1 - 2
3-4
5-6
7-8
9-10
11 +
Mean
35
135
80
34
15
1
11.7
45.0
26.7
11.3
5.0
0.3
4.6
Living Children
1 - 2
3-4
5-6
7-8
9-10
Mean
35
140
80
31
14
11.7
46.7
26.6
10.3
4.7
4.5
Residence
Urban
Rural
86
214
28.6
71.4
53
247
17.7
82.3
91
29
81
47
46
6
30.3
9.7
27.0
15.7
15.3
2.0
Employed
No
Yes'
Patient ’“s Education
(School years)
0
1 - 3
4-6
7-9
10 - 12
13 +
Mean
4.8
87
TABLE I (CONTD)
Sociodemographic Characteristics
Numb er
Percent
60
16
63
58
76
27
20.0
5.3
21.0
19.3
25.3
9.0
Husband’s Education
(School Years)
0
1 4 7 10 13 +
Mean
3
6
9
12
6.8
Spontaneous Abortion
0
1
2
3+
237
51
10
2
79.0
17.0
3.4
0.6
283
15
2
94.4
5.0
0.6
253
18
17
10
2
84.3
6.0
5.7
3.3
0.6
Induced Abortion
0
1
2
Previous Contraceptive Practice
None
IUD
Orals
Condom
Rhy thm/wi thdrawl
Technical Failures
Technical failure was reported for three cases. In one case, laparotomy was performed
because the left tube was not connected to the uterus and was found to be lying in
the left iliac fossa along with the ovary. In the second case, abdominal surgery was
performed because pneumoperitoneum could not be achieved and in the third case
laparoscopy was postponed as the patient developed hypotension after the laparoscope
was introduced. The technical failure rate was 1.0 percent.
Surgical Time
The majority (93..0%) of the sterilisation procedures were performed within five to
twelve minutes.(Table II and Fig 1). Mean surgical time was 8.8 minutes (Table II).
88
49.5
50
43.5
w
0)
w
cd
o
■M
25
£
0)
o
a)
Pm
4.7
2.3
0
5-8
9-12
13-16
17+
Surgical Time (Minutes)
Fig 1
SURGICAL TIME FOR 296 LAPAROSCOPIC STERILISATION PROCEDURES PERFORMED
PRIOR TO PREGNANCY TERMINATION AT THE KASTURBA MEDICAL COLLEGE
HOSPITAL, MANIPAL, AUGUST 1975 TO APRIL 1979
TABLE II
SURGICAL TIME FOR 296 LAPAROSCOPIC STERILISATION PROCEDURES PERFORMED PRIOR TO
PREGNANCY TERMINATION AT THE KASTURBA MEDICAL COLLEGE HOSPITAL, MANIPAL,
AUGUST 1975 TO APRIL 1979
Surgical Time (Minutes)
Numb er
Percent
5-8
9-12
13 - 16
17 +
Mean
147
129
14
6
49.5
43.5
4.7
2.3
TOTAL
296
8.8
100.0
89
Surgical Difficulties
Surgical difficulties were reported during 25 (8.3%) procedures. Difficulty
in locating the tubes (2.7%) and need for vaginal manipulation (2.7%) were the
most frequently reported causes of surgical difficulty. In this series, only
one minor technical difficulty (light source fuse) was reported (Table III).
TABLE III
SURGICAL DIFFICULTIES EXPERIENCED DURING 296*LAPARCSCOPIC STERILISATION
PROCEDURES PERFORMED PRIOR TO PREGNANCY TERMINATION AT THE KASTURBA
MEDICAL COLLEGE HOSPITAL, MANIPAL, AUGUST 1975 TO APRIL 1979
Number
Percent
Difficulty in locating tubes
Vaginal manipulation required
Retroverted uterus
Difficulty in creating pneumoperitoneum
Thickened tubes
Distended omentum
Light source fused
8
8
3
3
1
1
1
2.7
2.7
1.0
1.0
0.3
0.3
0.3
Procedures with one or more
Difficulties
25
8.3
Difficulties
*The three technical failures and one death are excluded from this table.
Mortality and Morbidity
There was one death in this series. The patient developed cardiac arrest soon
after pneumoperitoneum was started when*only 60 ml of air had been introduced.
She could not be revived inspite of external and internal cardiac massage and
defibrillation by a team of anesthetists and a cardothoracic surgeon
Death was
not due to air embolism as indicated by the fact that no air was withdrawn from
the right ventricle. The cause of death in this case was, probably, vasovagal
shock due to heavy sedation. The sedation schedule has since been minimized.
In this series, 10 (3.4%) women reported one or more complications. Operative and
immediate postoperative complications were reported for three (0.9%) cases. One oatient
(reported above) developed cardiac arrest, another hypotension and one patient
had fever requiring antibiotics. The incidence of early postoperative complications
was 2.4 percent. Infection was reported in all these cases (Table IV).
The incidence of complaints was 4.1 percent in the early postoperative period
(Table IV),
90
TABLE IV
COMPLICATIONS AND COMPLAINTS FOR 297* WOMEN UNDERGOING LAPAROSCOPIC STERILISATION
PRIOR TO PREGNANCY TERMINATION AT THE KASTURBA MEDICAL COLLEGE HOSPITAL,
AUGUST 1975 TO APRIL 1979
Number
Percent
1
1
1
0.3
0.3
0.3
Total
3
0.9
Early Postoperative Complications:
Fever requiring antibiotics
Wound infection
Pelvic infection
Urinary infection
3
2
1
1
1.0
0.6
0.3
0.3
Total
7
2.4
Women with one or more complications
10
3.4
Early Postoperative Complaints:
Backache
Weakness
Abdominal pain
Pain over scar
4
3
3
2
1.4
1.0
1.0
0.6
Women with one or more complaints
12
4.1
Complications/Complaints
Operative and Immediate Postoperative
C omplications:
Cardiac arrest**
Hypotension
Fever requiring antibiotics
* The three technical failures are excluded.
** Death occurred due to cardiac arrest.
DISCUSSION
When a woman requests sterilisation concurrently with abortion, the usual procedure
is to perform sterilisation after terminating her pregnancy. In some cases, however,
it may be desirable to perform sterilisation prior to pregnancy termination provided
that this does not increase the surgical risk of the procedure.
The results of this study show that the complication rates in the immediate (0.9%)
and early (2.4%) postoperative periods were lower than those reported in other
postabortion series where sterilisation was performed via laparoscopy. Immediate and
early postoperative complication rates in these series ranged between 1.3 and 1.4 and
4.6 and 11.3 percent respectively (6,7,10). In the present:study, the incidence of
surgical difficulties (8.4%) was higher than rates (5.6% to 8.0%) reported in other
studies (6,7,10,11). The various surgical difficulties encountered in this
91
and other postabortion (7,10) and interval (12) laparoscopic series were of a similar
nature. Difficulty in manipulating the heavy, pregnant retroverted uterus (2.7%) was,
however, unique to the present series. The incidence of technical failures in this
study was higher than that reported (0.0% - 0.7%) in other postabortion sterilisation
series (6,7,10,11).
The results of this study suggest that preabortion sterilisation by laparoscopic
electrocoagulation does not increase the incidence of postoperative complications.
However, this procedure was not technically easier than postabortion sterilisation
as was originally hypothesized. For making scientific comparisons between preabortion
and postabortion sterilisation procedures, controlled, random, comparative studies
are needed.
References
1. Pachaurij S. and John, E. Pregnancy termination with the Battelle Hand pump Studies in India, Scientific Papers of the India Fertility Research Programme3
p 189-199, 1980..
2. Miller, E., McFarland, V., Burnhill, M.S. and Armstead, J.W. Impact of the abortion
experience on contraceptive acceptance. Paper presented at the 25th Anniversary
Annual Clinical Meeting, The American College of Obstetricians and Gynaecologists,
Dallas, Texas, May 10-13, 1976.
Contraceptive practice
after women have undergone rspontaneous r abortion in Indonesia and Sudan. Int. J.
Gynecol Obstet 15: 241-249, 1977.
3. Rushwan, H., Doodolt, A., Chi, I-cheng., and Bernard, R.P.
4. Bhatt, R.V. and Basu, K.S. Acceptance of menstrual regulation for fertility control.
Fifth Transaction of Scientific Papers, India Fertility Research Programme,
41-45, 1978.
5. Rao, S.R., Kanitkar, S.D. and Brinton, L.A.
Postabortal fertility control acceptance.
Presented at the VI Asian Congress in Obstetrics and Gynaecology, Kuala Lumpur,
Malaysia, July 20^27, 1974.
6. Bhatt, R.V., Pachauri, S., Pathak, N.D., Chauhan, L.N. and John, E, A comparative
study of the tubal ring applied via minilaparotomy and laparoscopy in postabortion
cases in Baroda, India. Int. J Gynecol Obstet 16: (2) 162-166, 1978.
7. Pachauri, S., Jccmshedgi, A. and John, E. A comparision of the tubal ring applied via
laparoscopy, minilaparotomy and colpotomy in postabortion cases. Scientific papers
of the India Fertility Research Programme, 16-55, 1980,
8. Lean, T.H., Vengadasalam, 0. and Cole, L.P. A comparison of the clip and ring
techniques for laparoscopic sterilization of postabortion and postpartum patients. .
Int J Gynecol Obstet 16: 150-156, 1978.
9. Purandare3 B.N, Postpartum and postabortion sterilization.
24: 65-703 1976.
IntK J Gynecol Obstet
92
10. Khandwalla, S.D., Pachauri, S. and Nayak, P.G.. A comparison of laparoscopic
tubal ring and clip techniques of tubal ligation in postabortal cases.
Int J Gynecol Obstet 16: 115-118, 1978.
!
11. Motashob^ N.D. and Pachaurz^ S. A comparison of postabortion sterilisation
by laparoscopy and colpotomy. Scientific papers of the India Fertility
ResearchProgramne, 93-1031980.
12. Schramm, G., Guznan, R.S., Martinez,
Martine z, C.,
C.^ McCann, M. Sterilization by laparoscopic
electrocoagulation. A Report from Valduvia, Chile. Presented at Annual Meetzng,
International Family Planning Research Association, Beverly Rills, California,
September 29-October 2, 1976.
93
A COMPARISON OF POSTABORTION STERILISATION BY LAPAROSCOPY AND
COLPOTOMY
N.D. Motashaw, MD, FRCS1
Saroj Pachauri^ MD, DPH^ PhD,2
ABSTRACT
This study was conducted to evaluate and compare the safety and efficacy of the tubal
ring when applied via laparoscopy and colpotomy immediately after first trimester
abortion by suction evacuation. The sterilisation method was randomly assigned to the
study cases. A single operator performed all the surgical procedures and another
physician evaluated postoperative events in all study cases. Mean surgical and operating
room time were higher for colpotomy than for laparoscopy but the differences were not
statistically significant. There were no technical failures among the laparoscopy
cases. Although all sterilisation procedures were successfully performed via colpotomy,
in four cases an alternative technique was employed to occlude the Fallopian tube.
The incidence of technical and surgical difficulties was similar for the two study
groups. Operative and postoperative complication and complaint rates were not signi
ficantly different when sterilisation was performed via laparoscopy and colpotomy.
The incidence of gynaecological abnormalities reported six months poststerilisation
were also similar for these two groups of cases. No pregnancies were reported.
INTRODUCTION
Laparoscopic sterilisation has found widespread acceptance in both developed and
developing countries. As the electrocoagulation technique is associated with the
potential hazards of bowel burns, efforts are being made to replace it with noncautery
methods such as clips and rings. Most clips have been abandoned because of the high
failure rates associated with them (1,2,3). Studies with the tubal ring show that it
is a safe and effective technique of female sterilisation and that it can be used via
laparoscopy, colpotomy and minilaparotomy (2, 4-7). The colpotomy approach has been
extensively used in India as the absence of abdominal scar with this method makes it
acceptable to the Indian woman. The present study was conducted to evaluate and compare
the safety and efficacy of the tubal ring technique when applied via laparoscopy and
colpotomy in postabortion cases. The two sterilisation methods were randomly assigned
to the study subjects. All other variables such as type of anaesthesia, sterilisation
of surgical instruments*' and preoperative and postoperative procedures were held
constant throughout the study.
MATERIALS AND METHODS
From April 1975 to January 1979, 292 women underwent sterilisation with the tubal ring
at the KEM Hospital in Bombay. Sterilisation was performed immediately after suction
abortion in all cases. Data were collected using the standardized protocol of the
the India Fertility Research Programme. Six months follow-up data are reported for
95 cases.
T---Honorary Professor, Department of Obstetrics and Gynaecology, KEM Hospital, Bombay.
2
Research Director, India Fertility Research Programme, Hyderabad.
94
Study Design
The sterilisation method was randomly assigned to the patient immediately prior to
surgery, by having the surgeon who performed the procedure (the operator) open a
sealed envelope containing a card which specified the sterilisation method to be
used for that particular patient. In order to minimize inter-operator variability,
all study procedures were performed by a single operator.
In order to minimize evaluator bias, a second physician (the evaluator) was responsible
for the care of the patient after she was discharged from the operating room. The
evaluator was responsible for recording all complications, complaints, and other events
during the patient’s recovery period and at the time of the follow-up visits. Thus,
the operator performed the procedure and recorded data related to the procedure and
to events which occurred while the patient was in the operating room, The evaluator
was responsible for providing postoperative care and for recording data on all subsequent
visits.
Clinical Procedures
. The uterus was evacuated by suction curettage in all cases. All the study procedures
were performed with general anaesthesia. The patient was administered 0.6 mg of
atropine sulphate untramuscularly half an hour before the sterilisation procedure.
When sterilisation was performed via laparoscopy, the modified Hulka’s tenaculum
was introduced into the uterine cavity with one arc grasping the anterior lip of the
cervix. A small stab incision was made through the skin and subcutaneous fat just
below the umbilicus and pneumoperitoneum was created. The incision was then enlarged
transversely to accomodate the trocar and cannula and the operating laparoscope
loaded with the tubal ring was introduced. The Fallopian tube was identified, picked
up at a distance of about 4 cm from the uterine cornu by the grasping forceps and a
loop of the tube was drawn into the sleeve of the instrument. The tubal ring was
slipped on the tube which was then released from the grasping forceps. The procedure
was repeated with the other Fallopian tube. The laparoscope was removed and the
peritoneal cavity deflated. The skin incision was closed with a single stitch using
No. 00 chromic catgut and a dry gauze dressing was applied.
For colpotomy, the vagina was thoroughly cleansed with one percent Cetavlon, for
exactly 3 minutes by the clock. Cetavlon was wiped off with sterile gauze and the
vagina was swabbed with tincture of iodine or methylated spirit. A transverse incision
was made with scissors in the posterior fornix. The Fallopain tube picked up with a
Babcock’s forceps was held about 4 cm from the uterine cornu with the grasping forceps
of the tubal ring applicator and a loop of the tube was drawn into the sleeve of the
instrument. The tubal ring was slipped on to the tube which was then released from
the grasping forceps. The procedure was repeated with the other tube. The vaginal
wall and peritoneum were closed together with interrupted stitches using chromic
catgut. The vagina was packed for sik hours.
No prophylactic antibiotics were administered,
hospitalized for seven nights.
Most of the study subjects were
95
Subjects
Only women requesting sterilisation for reason of family limitation were included
in the study. Pre-existing systemic and/or pelvic disease was not a contraindication.
There was one case each of osteomalacia, treated tubercular meningitis, tuberculosis
of the lung, kyphoscoliosis, bronchial asthma and chronic pelvic infection among
the laparoscopy cases. There was one case each of chronic pelvic infection, removed
goitre, pulmonary tuberculosis, tuberculosis of the spine and schizophrenia (under
treatment) among the colpotomy cases. Previous pelvic surgery was reported for 3.5
and 6.7 percent of the laparoscopy and colpotomy patients respectively. This included
dilatation and curettage, caesarian section, previous sterilisation by Madleiner s
technique, abdominal surgery for lysis of burn adhesions, Meckel s diverticulum,
ileal perforation, appendectomy, Fothergill’s operation and perineal repair.
Definitions and Criteria
A technical failure was defined as a casei in which the designated procedure could
not be completed, Technical difficulty was defined as any difficulty associated
with the equipment. Surgical difficulty was any difficulty encountered during the
procedure which was not due to equipment-related problems.
Complications and complaints due to the sterilisation procedure were categorised as
operative, immediate,.early and delayed postoperative. Operative complications
and complaints were those occurring during surgery. Immediate complications and
complaints were those occurring after surgery but prior to the patient’s leaving
the operating room. Early postoperative complications and complaints were those
reported before the patient’s discharge from the hospital. Delayed postoperative
complications and complaints were those reported at the six months follow-up visit.
Surgical time was defined as the time from the commencement of dilatation to final
closure of the incision. Operating room time was the time from entering to leaving
the operation room; it included surgical time.
All statistical tests were performed using a significance level (p value) of 0.05.
RESULTS
Sociodemographic Characteristics
Women undergoing sterilisation via laparoscopy and colpotomy were similar with
respect to selected sociodemographic characteristics including age, parity, education,
employment and religion (Table I). The average woman in the study group was an
unemployed Hindu, in her early 30s with 3 to 4 live births and 4 to 5 years of
formal school education.
96
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 292 WOMEN UNDERGOING POSTABORTION STERILISATION
WITH THE TUBAL RING VIA LAPAROSCOPY AND COLPOTOMY AT THE KEM HOSPITAL, BOMBAY,
APRIL 1975 TO JANUARY 1979
Sociodemographic Characteristics
Laparoscopy
N = 142
No.
%
Colpotomy
N = 150
No.
%
8
42
48
34
10
7
43
55
31
14
Age (Years)
20 - 24
25 - 29
30 - 34
35 - 39
40 +
Mean
5.6
29.6
33.8
23.9
7.0
4.7
28.7
36.7
20.6
9.3
32.1
3 1.9
Parity
1 3 5 7 +
Mean
2
4
6
19.0
54.2
18.3
8.5
27
77
26
12
19.3
58.7
17.3
4.7
29
88
26
7
3.7
3.8
Education (School years)
0
1-3
4-6
7-9
10 - 12
13 +
Mean
39.4
5.6
23.2
19.0
9.9
2.8
56
8
33
27
14
4
43.3
4.7
15.3
19.3
14.0
3.3
65
7
23
29
21
5
4.6
4.5
Employed
No
Yes
118
24
83.1
16.9
124
26
82.7
17.3
117
14
9
2
82.4
9.9
6.3
1.4
124
13
11
2
82.7
8.7
7.3
1.3
Religion
Hindu
Muslim
Christian
Other
97
Surgical and Operating Room Time
for--colpotomy
minutes) than for . laparoscopy
Mean surgical time was higher -r--- J (14.7
.
significant.
(11.2 minutes) (Table II). However, the difference was not statistically sl
gnl^lcan^
l
woman
On an average, a woman undergoing laparoscopy spent 26.5 minutes and a v--- undergoing
colpotomy spent 30.5 minutes in the operating room (Table II). This difference was
also not statistically significant.
TABLE II
_ 7;SURGICAL AND OPERATING ROOM TIME
FOR 2;
292----WOMENj UNDERGOING POSTABORTION STERILISATION
WITH THE TUBAL RING VIA LAPAROSCOPY AND COLPOTOMY AT THE KEM HOSPITAL, BOMBAY,
APRIL 1975 TO JANUARY 1979
Time (Minutes)
Laparoscopy
N = 142
No.
%
Surgical:
<
5
6 - 10
11 - 15
16 - 20
21 - 25
26 +
Mean
13
65
35
20
6
3
9.2
45.8
24.6
14.1
4.2
2.1
Operating Room:
< 19
20 - 29
30 - 39
40 - 49
50 +
Mean
27
69
37
8
1
Colpotomy
N = 150
No.
%
14.7
11.2
19.0
48.6
2 6.1
5.6
0.7
26.5
0.7
21.3
40.7
22.7
9.3
5.3
1
32
61
34
14
8
5.3
50.0
28.0
12.7
4.0
8
75
42
19
6
30.5
Technical Failure
While there were no technical failures among the laparoscopy cases; four technical
failures were reported among the colpotomy procedures. In all four cases, sterilisation
was successfully performed via colpotomy. However, the technique used for tubal
occlusion was different from the planned tubal ring technique. In one case, the
tubal ring was applied successfully to the right tube but the left tube was ligated
by the Madleiner's technique because the mesosalpinx and the tubal wall were torn
by the grasping forceps. In another case the right tube was successfully occluded
with the tubal ring but as the left tube was adherent and could not be visualised,
it was consequently ligated by the Pomeroy technique and a part of it was sectioned.
In two cases, the tubal ring was successfully applied to occlude one tube. However,
the other tube could not be brought Into the operation field owing to the presence
of adhesions and so it was sectioned and tied.
98
Technical and Surgical Difficulties
Difficulties were reported with similar frequency when sterilisation was performed
via laparoscopy (5.67) and colpotomy (5.37) (Table III). There was no significant
difference in the incidence of technical difficulties encountered during the laparoscopy
(2.17) and colpotomy (1.37) procedures (Table III). During one laparoscopic procedure
the inner cylinder of the band applicator jammed with the outer cylinder. In another
case, the tongs of the applicator were not properly aligned and in the third case the
tubal ring broke during laparoscopic application. During one of the colpotomy procedures
there was inadequate light effecting visibility, and in another case the applicator
did not work well..
TABLE III
TECHNICAL/SURGICAL DIFFICULTIES REPORTED FOR 292 WOMEN UNDERGOING POSTABORTION
STERILISATION WITH THE TUBAL RING VIA LAPAROSCOPY AND COLPQTOMY AT THE KEM
HOSPITAL, BOMBAY, APRIL 1975 TO JANUARY 1979
Difficulty
Technical:
Applicator problems
Poor light source
Band broke
To tai
Surgical:
Omentum interference
Adhesions
Enlarged uterus
Difficulty in locating/exteriorising
tubes
Oedamatous tubes
Cannula introduced into nonpregnant
horn of bicornuate uterus
Total
Women with one or more difficulties
Laparoscopy
N=142
No.
%
Colpotomy
N=150
No.
%
2
0
1
3
1.4
0.0
0.7
2. J
1
1
0
2
0.7
0.7
0.0
1.3
2
2
1
1.4
1.4
0.7
0
2
0
0.0
1.3
0.0
0
0
0.0
0.0
2
1
1.3
0.7
0
5
0.0
3.5
1
6
0.7
4.0
8
5.6
8
5.3
The incidence of surgical difficulties during laparoscopy (3.57) and colpotomy (4.07)
was not significantly different. While the presence of adhesions and omental inter
ference were the main causes of surgical difficulty during laparoscopy, difficulty in
visualising and exteriorizing the tubes was the most common problem during colpotomy
(Table III).
99
Complications
Abortion complications were encountered with similar frequency for laparoscopy (4.2%)
and colpotomy (4.7%). Uterine perforation was reported for 3 (1.0%) cases and bleeding
requiring transfusion for 2 (0.7%) cases (Table IV). In one case of uterine perforation
the injury was not noticed during laparoscopy as the bleeding was extraperitoneal.
Subsequently laparotomy was performed to remove the extravasated blood and to repair
the rent.
The total incidence of sterilisation complications among women undergoing laparoscopy
(4.9%) was not significantly different from those undergoing colpotomy (4.7%) (Table IV),
The incidence of sterilisation and abortion complications were similar for
the two groups of cases (Table IV).
TABLE IV
COMPLICATIONS REPORTED FOR 292 WOMEN UNDERGOING POSTABORTXON STERILISATION WITH
THE TUBAL RING VIA LAPAROSCOPY AND COLPOTOMY AT THE KEM HOSPITAL, BOMBAY,
APRIL 1975 TO JANUARY 1979
Laparoscopy
N=142
%
No.
Complications
Abortion related:
Blood loss > 100 ml
With transfusion
Without transfusion
Cervical tear
Uterine perforation
Total
Sterilisation related:
Operative:
Partially torn tube
Tear in mesosalpinx
Knuckle of tube divided
Avulsion of tube
Bronchospasm due to anaesthesia
To tai
Immediate Postoperative:
Ha ema toma
Total
Early postoperative:
Fever requiring antibiotics
Fever not requiring antibiotics
Serous discharge from wound
To tai
Women with one or more sterilisation
complications
Colpotomy
N=150
No.
%
1
1
2
2
6
0.7
0.7
1.4
1.4
4.2
1
4
1
1
7
0.7
2.7
0.7
0.7
4.7
1
1
1
0
1
4
0.7
0.7
0.7
0.0
0.7
2.8
0
1
0
1
1
3
0.0
0.7
0.0
0.7
0.7
2.1
2
2
1.4
1.4
0
0
0.0
0
0
1
1
0.0
0.0
0.7
0.7
2
2
0
4
1.3
1.3
0.0
2.6
7
4.9
7
4.7
0.0
100
The operative complication rates were 2.8 and 2.1 percent respectively for laparoscopy
and colpotomy. The only immediate postoperative complication was the development ot
a haematoma in two patients who underwent laparoscopic sterilisation (Table IV).
The incidence of early postoperative complications was higher for the colpotomy
(2.6%) than for laparoscopy (0.7%) cases. However, this difference was not statistically
significant (Table IV).
There was not significant difference in the incidence of gynaecological abnormalities
6 months after sterilisation for women who underwent laparoscopy (26.1Z) and colpotomy
(22.4%). Cervical erosion was reported for 8.7 and 10.2 percent cases respectively.
One woman developed carcinoma in situ after colpotomy. A leukoplakic patch was
reported for one and dysplasia for another case after laparoscopic sterilisation.
Cystocoele was reported for 6.5 and 4.1 percent of the laparoscopy and colpotomy cases
respectively and rectocoele for 2.2 and 4.1 percent cases respectively (Table V).
In this series, there was only one woman who underwent pelvic surgery (dilatation and
curettage) poststerilisation.
TABLE V
GYNAECOLOGICAL ABNORMALITIES REPORTED FOR 95 WOMEN SIX MONTHS AFTER STERILISATION
VIA LAPAROSCOPY AND COLPOTOMY AT THE KEM HOSPITAL, BOMBAY, APRIL 1975 TO JANUARY
1979
Gynaecological Abnormalities
Laparoscopy
N=46
No.
%
Colpotomy
N=49
No.
%
Cervical erosion
Cystocoele
Leukoplakic patch
Carcinoma in situ
Rectocoele
Dysplasia
Vulval furuncles
Uterus descent
Vaginal cyst
4
3
1
0
1
1
0
1
1
8.7
6.5
2.2
0.0
2.2
2.2
0.0
2.2
2.2
5
2
0
1
2
0
1
0
0
10.2
4.1
0.0
2.0
4.1
0.0
2.0
0.0
0.0
Women with one or more abnormalities
12
26.1
11
22.4
Complaints
The incidence of immediate postoperative complaints was higher for women who underwent
colpotomy (5.3%) than for those who underwent laparoscopy (2.8%). However, this
difference was not statistically significant. Pelvic pain was reported by only 2.8 and
3.3 percent of these cases respectively (Table VI). The incidence of early postoperative
complaints was similar for the laparoscopy (8.4%) and colpotomy (8.7%) cases,
At six months follow-up visit, 15.2 and 14.3 percent of the women sterilised via
laparoscopy and colpotomy reported pelvic pain (Table VI)•
101
TABLE VI
COMPLAINTS REPORTED FOR 292 WOMEN UNDERGOING POSTABORTION STERILISATION
WITH THE TUBAL RING VIA LAPAROSCOPY AND COLPOTOMY AT THE KEM HOSPITAL,
BOMBAY, APRIL 1975 TO JANUARY 1979;
Laparoscopy
N=142
%
No.
Complaints
Immediate Postoperative:
Pelvic pain
Burning micturition
Chest pain
Weakness
Total
Early Postoperative:
Pelvic pain
Spotting
Bleeding
Weakness
Total
Delayed postoperative:
Pelvic pain
Colpotomy
N=150
%
No.
4
0
0
0
4
2.8
0.0
0.0
0.0
2.8
5
1
1
1
8
3.3
0.7
0.7
0.7
5.3
4
8
0
0
12
2.8
5.6
0.0
0.0
8.4
5
3
4
1
13
3.3
2.0
2.7
0.7
8.7
15.2
7
N=49
N=46
7
14.3
Failures
N» pregnancies h.ve been reported to date; 292 oo.en In this study were tollow.d
up for 1,878 woman months.
COMMENT
t-h-ic; carefully controlled, random study indicate that the tubal ring
be safely applied via laparoscopy and oolpoto.y In postabortlnn oase..
clinically acceptable complication
::2sSteSa“:1S:oX“iore:^~t:lr:“f heater coneetn. The complication
Jar eolpoiow tn this serie, wa. sl.ll.r to that reported in other studies (5,8,9).
The reported incidence of major complications for pooled analyses of 5,000; and 1,043
colpotomy cases was 3.5 and 5.6 percent respectively (10,11).
mu
11-c
c^sttS8::c::L2efSXc:aS
iVarX; Ls ^0^ to 1^
one 0; both tubes (8). In the present study the technique o tubal
aU
to be changed in 0.7 percent colpotomy cases due to pelvic path
8^
incidence of
procedures were completed through the colpotomy approach. The 5ep°^^p
q to
technical failures with laparoscopic application of the tubal ring range from 0.0 to
102
0.7 percent in various studies (1,4,10,12,13). No failures were reported for this
series and the frequency of technical and surgical difficulties was similar for
laparoscopy and colpotomy. It is hypothesized that the incidence of subsequent
gynaecological pathology and consequent pelvic surgery is high among sterilised
women. The reported incidence of gynaecological abnormalities on longterm follow-up
of women undergoing sterilisation with the tubal ring was higher in this than in
some other studies (2,13). However, this analysis included a smaller sample of
cases. Longer follow-up of larger series is needed for this evaluation.
The six and twelve month failure rates in a pooled analysis of 797 tubal ring
cases were 0.2 and 0.3 per 100 women respectively (1). In Singapore the corresponding
rates were 1.4 and 2.7 for postabortion cases (4). No failures with the tubal
ring were reported in studies conducted at Bombay (13) and Baroda (6). In this
study, also no pregnancies were reported to date. Further follow-up is required
to document failure rates, change in menstrual patterns and the incidence of
future gynaecological abnormalities.
REFERENCES
1. Kessel, E., and McCann, M.F. Laparoscopic tubal occlusion by electrocoagulation
spring-loaded clip and tubal ring. Presented at the 1st Inter-congress, Aszan
Federation of Obstetrics and Gynaecology, Singapore, April 27-30, 1976.
2. McCann, M.F. and Kessel, E. International experience with laparoscopic sterili
sation: Follow-up of 8500 women. Presented at the 14th Annual Scientific
Meeting, Association of Planned Parenthood Physicians, Miami Beach, Florida,
November 10-12, 1976.
S. Arnold, S.W.,
S.W'j Morrison,
Morrison^ J.C.
J.C, and
and Fish,
F'is'h^ S.A,
S.A. Puerperal week clip sterilisation:
Study I (First study of tu)o consecutive studies). Fertility and Sterility 27:
141^1414:, 1976.
4. Lean, T.H., Vengadasalam, D. and Cole, L.P. A comparison of the clip and ring
techniques for laparoscopic sterilisation of postabortion and postpartum patients.
Int. J. Gynecol. Obstet. 16: 150-156, 1978.
5. Motashaw, N.D., Pachauri, S. and Bhiwandiwalla, P. Sterilisation with the tubal
ring via laparoscopy and colpotomyvin postabortion cases : A comparative
Proceedings of the Seventh Asian Congress of Obstetrics and Gynaecology. The
Asian Federation of Obstetrics and Gynaecology, p 415-418, 1977.
6. Bhatt, R.V., Pachauri, S., Pathak, N.D. and John, E. A comparative study of
the tubal ring applied via minilaparotomy and laparoscopy in postabortion cases.
Int. J. Gynecol. Obstet. 16: 162-166, 1978.
7. Oblepias, V.R. and Pachauri, 5. A comparison of^electrocoagulationi and tubal
ring techniqU.es of laparoscopic sterilisation, jPhilippine J of Obstet. Gynaec.
Vol. 1, No.l, November 1976.
103
8. Batliwalla, P.R. and Mehtaji, S.P. Vaginal sterilisation - A review of 1164
cases. Proceedings of the Seventh Asian Congress of Obstetrics and Gynaecology,
The Asian Federation of Obstetrics and Gynaecology, p 342-346, 1977.
- - ”, Problems of female sterilisation by
9. Dube, S., Sharma, D,, and• Sharma,
C.L.N.
The
J.
Of
Obstet.
Gynae. of India, Vol. XXVIII, Ro. 2,
vaginal approach. '
p 220-224, 1978.
10. Wortman, J. and Piotrow, P.T. Colpotomy: The vaginal approach.
Report Series C3
June 1973
11. Berger, G.S. and Keith, L.H. Colpotomy for female sterilisation.
Surgery9 62:72^ 1977.
Population
Interna tional-
12, Kwak, H.M., Song, C.H. and Saha, A. Laparoscopic sterilisation by tubal ring
and electrocoagulation. Presented at the Second International Congress of
Gynaecologic Endoscopy, Las Vegas, Nevada, November 20-23, 1975.
13. Khandwalla, S.D., Pachauri, S.,.Nayak, P.G. and Pai, D.N. _ Laparoscopic
sterilisation with the spring-loaded clip and tubal ring in postabortion cases
One year follow-up. Int. J Obstet. Gynaec. 16: 115-118, 1978.
104
MATERNITY CARE MONITORING: AN ILLUSTRATION.
FROM INDIA
Saroj Pachauri, MD, DPH, PhD^
Armin Jamshedji, MA^
ABSTRACT
This paper presents a pooled analysis of data on 15,221 maternity cases at nine
institutions in India. It documents the quality of feedback provided by the
computerized system of Maternity Care Monitoring (MCM) and illustrates its
utilization. MCM provides baselines on high risk groups and periodic examination
of indices of maternal and perinatal health. It, thereby, serves as a tool for
highlighting lacunae in service programmes and assists programme planners and
service providers to delineate priorities and implement appropriate measures
for improving the quality of care.
INTRODUCTION
Care of the mother and the infant before, during and after delivery is of the
utmost concern to professionals engaged in the fields of obstetrics, gynaecology
and perinatology. Efficient monitoring of maternity care programmes is, therefore,
a priority for those engaged in these tasks. This involves the establishment
of clinical baselines on the risk groups to be served, followed by periodic
examination of indices of maternal and perinatal health to highlight lacunae and
to implement appropriate health measures for reducing morbidity and mortality
among populations served.
The International Federation for Family Health (IFFH) is assisting its member
countries to incorporate within their service programmes, a standardized system
for Maternity Care Monitoring (MCM) capable of providing periodic, computerized
feedback for evaluating a broad range of factors governing high risk groups,
management and outcome of delivery as well as intervention to improve future
outcome. This system also enables epidemiological comparisons between biological
and socio-environmental factors which operate interactively to influence pregnancy
outcome (1-3). In India, more than 35 institutions have implemented this system
(4-6). This paper presents a pooled analysis of maternity data from nine of
these institutions; it documents the quality of feedback provided by this system
and provides an illustration of its utilisation.
MATERIALS AND METHODS
Data on 15,221 women delivering 15,424 infants in India from January 1976 to
“"' are reported.
t
All institutions reporting data utilised the computerized
December 1?
1978
and standardized system for MCM of the India Fertility Research Programme (India FRP).
Project Director, ^Research Assistant, International Maternity Care Monitoring
Project, Hyderabad.
o
Ln
Fig 1
MAP OF INDIA SHOWING LOCATION OF CONTRIBUTING CENTRES
106
Figure 1 is a map of the country showing the location of institutions from which
data for this paper are drawn. Table I lists these institutions by place and
shows the number of deliveries by time for each participating institution. Data
on sociodemographic characteristics, obstetric history, antenatal, intranatal
and postnatal status of the mother, management and outcome of delivery and neonatal
status were recorded on standard, one-page forms of the India FRP.
TABLE I
CONTRIBUTING INSTITUTIONS BY PLACE, TIME AND NUMBER OF DELIVERIES
Institution
Contributor
State
Place
Gujarat
Baroda
Baroda Medical College
Hospi tai
R.V. Bhatt
Maharashtra
Bombay
Nowrosjee Wadia
Maternity Hospital
Dina Patel
Maharashtra
Bombay
King Edward Memorial
Hospital
V.N.Purandare
Maharashtra
Bombay
Balabhai Nanavati
Hospital
C.L. Jhaveri
Maharashtra
Bombay
Cama & Albless
Hospitals
S. Mehtaji
Maharashtra
Bombay
Hospital for Women
A.C. Mehta
Kama taka
Manipal
Kasturba Medical
College & Hospital
Padma Rao
Delhi
New Delhi Kasturba Hospital
M. Kochhar
West Bengal
Calcutta
S.S.K.M. Hospital
S. Banerjee
Inclusive
Delivery
Dates
Number of
Cases
January 1977
to
July 1978
3686
June 1977
to
August 1978
3164
July 1977
to
January 1978
1963
February 1977
to
April 1978
1234
May 1977
to
July 1978
729
January 1977
to
September 1978
907
Augus t 1977
to
December 1978
2151
August 1977
to
December 1978
904
June 1977
to
December 1978
483
107
TABLE II
SOCIODEMOGRAPHIC CHARACTERISTICS OF 15,221 WOMEN DELIVERED IN SELECTED MATERNITY
CENTRES IN INDIA, JANUARY 1976 TO DECEMBER 1978
Sociodemographic Characteristics
Number
Percent
984
5944
5107
2210
838
121
17
6.5
39.1
33.6
14.5
5.5
0.8
0.1
Age (Years)
< 19
20 - 24
25 - 29
30 - 34
35 - 39
40 +
Unknown
Mean
25.9
Number of Living Children
0
1
2
3-4
5-6
7 +
Unknown
Mean
36.0
26.4
17.4
13.6
3.0
0.7
2.9
5481
4015
2647
2073
452
113
440
1.3
Education (School years)
0
1 - 2
3-4
5-6
7-8
9-10
11 - 12
13 +
Unknown
Mean
10.0
2.0
5.1
6.5
6.4
5.3
5.1
3.5
56.1
1527
302
769
986
972
812
783
530
8540
6.2
Marital Status
Currently married
Formerly married
Never married
Other
Unknown
14640
492
56
6
27
96.2
3.2
0.4
0.0
0.2
Residence
Urban
Rural
Slum
Unknown
9472
5161
560
28
62.2
33.9
3.7
0.2
Definitions and Criteria
All deliveries regardless of outcome were included in the study. Women admitted
for induced and spontaneous abortion (with a foetus weighing less than 500 grams
and gestation upto 19 weeks), molar pregnancies and false labour were excluded.
The duration of pregnancy was estimated in completed weeks from the onset of the
woman’s last normal menstrual period to the day of delivery.
In cases with multiple complications, only the primary complication was reported.
Women with haemoglobin less than .10 gm/100 ml were categorized as anaemic. For
classifying antenatal conditions, the 9th edition of the WHO International Classifi
cation of Disease was used. For estimating perinatal mortality rates, stillborn
infants weighing 1000 grams or more and early neonatal deaths were included.
Neonatal death was defined as infant death prior to discharge from the hospital.
RESULTS
Sociodemographic Characteristics
The average woman in the study group was an urban resident (62.2%), 25.9 years of
age with 1.3 living children and 6.2 years of formal education, The proportion
of women below 19 (6.5%) and above 34 (6.3%) years of age was low. While 36.0
percent of the women had no living child, 26.4 percent had only one living child
and only 3.7 percent had more than 4 living children (Table II). The desired
family size of the study group was 3.4 children, For women below 20 years of age
it was 2.9 children; for women at 20 to 29 and 30+ years it was 3.'3 and 5.0
children respectively. The mean age of the youngest child was 3.2 years.
6.0
•H
OJ
3.0
d
0)
S
0
< 19
-29
-39
40+
Maternal Age
Fig 2
MATERNAL AGE BY PARITY FOR 15,221 WOMEN DELIVERED IN
SELECTED MATERNITY CENTRES IN INDIA, JANUARY 1976
TO DECEMBER 1978
109
TABLE III
OBSTETRIC EVENTS REPORTED BY 15,221 WOMEN DELIVERED IN SELECTED MATERNITY
CENTRES IN INDIA, JANUARY 1976 TO DECEMBER 1978
Obstetric Events
Percent
Number
Live births
0
1
2
3
4
5 +
Unknown
Mean
34.3
26.5
18.2
10.4
5.4
5.0
0.3
5215
4027
2768
1589
815
767
40
1.5
Infant Deaths
0
1
2
3 +
Unknown
Mean
90.0
5.6
1.1
0.4
2.9
13692
855
169
59
446
0.1
Stillbirths
0
1
2+
Unknown
Mean
96.2
3.0
0.6
0.2
14646
452
94
29
0.04
Spontaneous abortions
0
1
2
3+
Unknown
Mean
90.0
7.6
1.7
0.5
0.2
13701
1153
261
78
28
0.1
Induced abortions
0
1
2+
Unknown
Mean
15008
164
16
33
98.6
1.1
0.1
0.2
0.01
110
The percentage of illiterate women (10.0%) and those with <5 years (7.1%) of
formal education was low (Table II). The majority of the deliveries were booked
(74.0%), non-private (84.5%) cases who were generally hospitalised for more than
3 nights (82.9%); only 0.8 percent were emergency admissions.
The women in this series had an average of 1.5 live births; 34.3 percent were
nulliparous and 26.5 percent had had only one live birth (Table III). Mean
parity gradually increased from 0.4 for women below 20 to 3.3 for women who were
30 to 39 years of age; there was a sharp increase to 5.1 for women who were 40+
years of age (Fig 2). Previous infant deaths, stillbirths, spontaneous and
induced abortions were reported by 7.1$ 3.6, 9.8 and 1.2 percent of the women
respectively (Table III).
TABLE IV
DELIVERY DATA FOR WOMEN DELIVERED IN SELECTED MATERNITY CENTRES IN
INDIA, JANUARY 1976 TO DECEMBER 1978
Delivery
Number
N = 14,656
Type of Delivery
Spontaneous
Spontaneous assisted
Caesarian section
Outlet forceps
Vacuum extractor
Mid/high forceps
Breech
Destructive procedure
Other
11964
1220
849
187
114
99
67
4
152
Attendant at Delivery
Nurse
Obstetric, /gynaecologist physician
General physician
Student nurse/midwife
Qualified midwife
Paramedic
Medical student
Other
81.6
8.3
5.8
1.3
0.8
0.7
0.5
0.0
1.0
N = 15,169
31.9
25,2
18.4
14.6
6.7
0.2
1.0
0.1
4842
3818
2786
2217
1013
37
156
15
Type of Labour
Spontaneous
Induced
No labour
Other
Percent
N = 15,019
14094
408
357
160
93.8
2.7
2.4
1.1
Note: Only cases with available data are included in this and subsequent
tables.
Ill
The Delivery
Delivery was spontaneous in 81.6 percent cases. Caesarian section was performed
in 5.8 and forceps were used in 2.8 percent cases. The incidence of breech
deliveries was 0.5 percent (Table IV). Spontaneous deliveries were reported more
frequently for multiparas (92.8%) and grand multiparas (94.9%) than for primiparas
(83.6%). Caesarian section and forceps deliveries were more common among primiparas
(8.4% and 6.3%) than among multiparas (4.8% and 1.0%) and grand multiparas
(3.0% and 0.6%).
In 43.6 percent cases a doctor attended the delivery, A fourth of the deliveries
were conducted by specialists in obstetrics and gynaecology, A third of the
deliveries were conducted by nurses (Table IV).
Labour was spontaneous in 93.8 percent cases. In 2.7 percent cases labour was
induced and 2.4 percent of the women did not go into labour (Table IV).
The mean birth weight of the infants in this series was 2668.4 grams. While 29.2
percent of the infants weighed less than 2500 grams, 7.6 percent weighed less than
2000 grams (Fig 3). Mean Apgar Score at one and five minutes was 7.4 and 7.5
respectively.
50
41.3
cn
0)
CD
nJ
o
4-J
24.1
25
. C
21.6
a)
Bl
0)
O
■
<<<>>>>:
S;
5.5
4.9
2.7
0
•W
EM
<1499
.•.•.•.•.•.•.•I-
-1999
-2499
-2999
-3499
3500+
Birth Weight
Fig 3
BIRTH WEIGHT OF 15,355 INFANTS DELIVERED IN SELECTED MATERNITY
CENTRES IN INDIA, JANUARY 1976 TO DECEMBER 1978
112
TABLE V
ANTENATAL COMPLICATIONS FOR 13,162 WOMEN DELIVERED IN SELECTED MATERNITY CENTRES
IN INDIA, JANUARY 1976 TO DECEMBER 1978
Number
Percent
1457
28
8
21
4
1
1519
11.1
0.2
0.1
0.2
0.0
0.0
11.5
15
8
24
176
21
3
247
0.1
0.1
0.2
1.3
0.2
0.0
1.9
0.2
0.1
0.2
0.0
0.2
Total
25
19
20
1
21
86
Total
29
1
1
8
1
10
41
3
4
98
0.2
0.0
0.0
0.1
0.0
0.1
0.3
0.0
0.0
0.7
Infections
Chorio/amnionitis-other pelvic
Respiratory tract infections
Tuberculosis
Syphilis
Malaria
Other systemic infections
Total
18
16
9
7
5
10
65
0.1
0.1
0.1
0.1
0.0
0.1
0.5
Antenatal Complications
Blood Disorders
Iron deficiency anaemia
Sickle cell anaemia
Other anaemia
Isoimmunization due to Rh
Isoimmunization due to ABO
Other
Total
Hypertensive Disorders
Chronic hypertension
Chronic hypertensive/pre-ecclampsia
Hypertension of this pregnancy
Pre-ecclamptic toxemia
Ecclampsia
Other
Total
Bleeding Disorders
Threatened abortion
Placenta previa
Placenta abruptio
Rupture of marginal sinus
Other bleeding per vagina
Anamolies/Abnormal!ties
Incompetent cervix
Vesicovaginal fistula
Rectovaginal fistula
Genital
Geni to-ur inary
Cardiac
Skeletal pelvic
Skeletal non-pelvic
Other
0.7
113
TABLE V (CONTD)
Number
Percent
Gastrointestinal Disorders
Gastrointenstinal infections
Intestinal parasites
Ileitis/colitis
Cholecystitis/cholelithiasis
Appendicitis
Hemorrhoids
Other
Total
24
13
7
5
2
2
8
61
0.2
Cardiovascular Disorders
Varicose veins
Thrombophlebitis
Other vascular disorders
Functional cardiac disorders
Total
7
2
8
24
41
0.1
0.0
0.1
0.2
0.3
16
19
2
1
38
0.1
0.1
0.0
0.0
0.3
14
1
4
2
21
0.1
0.0
0.0
0.0
0.2
Total
2
1
1
4
0.0
0.0
0.0
0.0
Total
4
1
5
0.0
0.0
0.0
2
1
3
56
0.0
0.0
0.0
0.4
Antenatal Complications
Endocrinal Disorders
Diabetes mellitus
Diabetes gestational
Hypothyroid
Hyperthyroid
Total
Urinary Tract Disorders
Lower urinary tract infection
Acute nephritis/pyelonephritis
Chronic nephritis/pyelonephritis
Other
Total
Neurological Disorders
Epilepsy
Encephalitis
Other
Psychiatric Disorders
Hyperernesis gravidarum
Psychosis
Cancer
Cervix
Leukemia
Total
Other Disorders
0.1
0.1
0.0
0.0
0.0
0.1
0.5
114
Maternal Morbidity
Iron deficiency anaemia (11.1%) was the most frequently reported primary antenatal
complication. The incidence of other anaemias was 0.3 percent. After anaemia,
the next most common antenatal complications were hypertensive disorders (1.9%)
including hypertension, pre-ecclampsia and ecclampsia. Pre-ecclamptic toxemia
with and without chronic hypertension was reported for 0.1 and 1.3 percent cases
respectively. The incidence of ecclampsia was 0.2 percent for the series (Table V).
Bleeding disorders including threatened abortion (0.2%), placental haemorrhage
(0.3%) and other vaginal bleeding (0.2%) were reported for 0.7 percent cases.
The incidence of all anamolies and abnormalities was 0.7 percent; the most common
of these were skeletal abnormalities of the pelvis (0.3%); incompetent cervix
(0.2%) and cardiac (0.1%) and genital (0.1%) anamolies and abnormalities (Table V).
Infections including systemic and pelvic infections were reported for 0.5 percent
cases. The incidence of intestinal disorders including infections, infestations,
and inflammatory conditions was 0.5 percent. Cardiovascular and endocrinal disorders
were each reported in 0.3 and urinary tract infection in 0.2 percent cases. The
reported incidence of psychiatric and neurological disorders and cancers was less
than 1.0 percent (Table V).
The incidence of intranatal complications was 8.9 percent, Prolonged/obstrueted
labour (4.6%) was the most common primary intranatal complication (Table VI).
TABLE VI
INTRANATAL COMPLICATIONS BY NEONATAL STATUS OF 14,703 CASES DELIVERED IN
SELECTED MATERNITY CENTRES IN INDIA, JANUARY 1976 TO DECEMBER 1978
Intranatal Complications
Prolonged/obstructed labour
Placenta previa/abruptio
Hypotonic uterine contractions
Hypertonic uterine contractions
Other
TOTAL
Discharged
Alive
Neonatal
Death
Stillbirth
Total
4.2
0.7
0.6
0.02
2.3
8.4
2.3
0.3
0.0
7.7
14.4
8.5
0.2
0.0
14.0
4.6
0.9
0.6
0.02
2.8
7.8
18.7
37.1
8.9
Note: Only primary complications are reported.
Complications during the puerperium were reported for 3.5 percent cases, Postpartum
haemorrhage (1.0%), fever requiring antibiotics (0.5%), urinary tract infection (0.1%),
bleeding requiring treatment (0.1%)and dehiscence (0.1%) were frequently reported
primary postnatal complications (Table VII). Blood transfusion was given to 1.5,
2.1 and 3.3 percent primiparas, multiparas and grand multiparas respectively.
115
TABLE VII
POSTNATAL COMPLICATIONS FOR 15,181 WOMEN DELIVERED IN SELECTED
MATERNITY CENTRES IN INDIA, JANUARY 1976 TO
DECEMBER 1978
Postnatal Complications
Postpartum haemorrhage
Fever requiring treatment
Urinary tract infection
Dehiscence
Bleeding requiring treatment
Retained products
Mastitis
Phlebitis
Other
TOTAL
Number
Percent
149
78
20
15
13
8
7
3
218
1.0
0.5
0.1
0.1
0.1
0.1
0.1
0.0
1.4
511
3.5
Note: Only primary complications are reported.
Foetal and Neonatal Mortality
In 92.0 percent cases the condition of the neonate was normal. Foetal distress
dpring labour was reported for 3.5 percent cases and major and minor malformations
for 0.6 and 0.1 percent cases respectively. Icterus was reported for 0.6 percent,
respiratory distress syndrome for 0.2 percent and trauma for 0.2 percent of the
newborn infants (Table VIII).
TABLE VIII
NEONATAL COMPLICATIONS BY STATUS OF THE NEWBORN FOR 14,659 INFANTS
DELIVERED IN SELECTED MATERNITY CENTRES IN INDIA, JANUARY 1976 TO
DECEMBER 1978
Neonatal Complications
Discharged
Alive
Neonatal
Deaths
Stillbirth
Total
Foetal Distress during labour
Minor malformation
Major malformation
Respiratory distress syndrome
Icterus
Neonatal sepsis
Trauma
Other
2.8
0.1
0.3
0.1
0.6
0.1
0.2
0.9
19.3
0.5
8.9
10.9
1.0
2.1
2.1
30.7
2 5.5
0.6
9.2
0.0
0.0
0.0
0.6
57.9
3.5
0.1
0.6
0.2
0.6
0.1
0.2
2.6
93.8
__________ TOTAL________________ 5.1
______ 75.5
Note: Primary complications for only single deliveries are reported.
7.9
116
Maternal and Perinatal Mortality
f
Twenty maternal deaths were reported for this series. Thus, the maternal mortality
rate was 1.3 per 1000. The perinatal mortality rate was 47.9 per 1000 and the
stillbirth and neonatal mortality rates were 30.5 and 21.1 per 1000 respectively
(Table IX). Of the perinatal deaths, death of the foetus occurred during the
antenatal period in 29.1 percent cases. Death of the newborn occurred during
the intranatal and postnatal periods in 30.0 and 37.8 percent cases respectively.
TABLE IX
MORTALITY RATES FOR 15,221 CASES DELIVERED IN SELECTED MATERNITY
CENTRES IN INDIA, JANUARY 1976 TO DECEMBER 1978
Mortality
Maternal mortality
Stillbirths
Neonatal mortality*
Perinatal mortality**
Number
Rate/1000
Deliveries
20
470
315
739
1.3
30.5
21.1
47.9
^Deaths before discharge to infants born alive.
**Neonatal deaths plus stillbirths weighing at least 1000 grams.
Maternal Correlates
While the incidence of antenatal complications was highest for older women (40+ year's),
intranatal complications were reported more frequently for women below 20 and above
39 years of age (Fig 4). However, these age differentials were not statistically
significant.* Maternal morbidity rates for all complications and also for the
antenatal, intranatal, and postnatal categories of complications were significantly
higher for primiparas than for multiparas and grand multiparas (Fig 4). The antenatal
complication rate was significantly lower for grand multiparas (13.2%) than for multi
paras (17.1%) and primiparas (18.2%) but the morbidity differential between primiparas
(18.2%) and multiparas (17.1%) was not significant (Fig 4). The incidence of iron
deficiency anaemia was significantly higher for multiparas (12.1%) than for primiparas
(9.8%). It was also significantly higher for grand multiparas (9.9%) than for
multiparas.
The intranatal complication rate was significantly higher for primiparas (15.9%)
than for multiparas (6.9%) (Fig 4). The incidence of prolonged/obstructed labour
and abnormal uterine contractions was significantly higher for primiparas. Placental
complications and postpartum haemorrhage were reported more frequently for multiparas
and grand multiparas than for primiparas but the differences were not statistically
significant. Parity differentials for postnatal complications were not statistically
significant (Fig 4).
*For this and all subsequent significance tests, the probability is greater than
95 nprcpnf
20.0
20.0
19.2
Antenatal
16.5
CO
Intranatal
X
\ Intranatai
nJ
o
e
15.9
4-»
nJ
o
u
Antenatal
co
a
o
a
o
•H
18.2
♦
o
S
o
10.0
10.0
cj
10.2
c<D
C
%
0)
(J
U
P
0)
6.9 *••**-;
0)
Ph
Postnatal
3.1
..2.8
2.0
0
I
I
1
<19
20 - 29
30 - 39
Maternal Age
I
0
Primipara
40 +
Fig 4
Multi para
Grand multipara
Pari ty
COMPLICATIONS BY AGE AND PARITY FOR 15,221 WOMEN DELIVERED IN SELECTED MATERNITY CENTRES
IN INDIA, JANUARY 1976' TO DECEMBER 1978
118
Primiparas (2634.8 grams) delivered infants with lower mean birth weight than
multiparas (2733.3 grams) and grand multiparas (2792.6 grams). Mean Apgar
Scores were 7.4, 7.4 and 7.1 at one minute and 7.6, 7.5 and 7.2 at five minutes
respectively for primiparas, multiparas and grand multiparas respectively.
Parity differentials for birth weight and Apgar Score were not statistically
significant. Mean birth weight was lower for anaemic (2601.8 grams) than for
non-anaemic (2726.0 grams) women. This difference was also not statistically
significant.
Neonatal Correlates
A significantly higher proportion of women who did not receive any antenatal care
and stillbirths (60.9%) and neonatal deaths (45.1%) when compared to those whose
infants were discharged alive (22.5%) (Fig 5).
Discharged Alive
80.0
Neonatal Death
o
w
d
u
Stillbirth
40.0
oo
c
a<u
(D
U
CM
o
CD
P-<
a)
PLI
0
All Complications
No Antenatal Care
80.0
80.0
to
O
00
3
a
a>
o
n
o
o
40.0
<D
w
al
o
c
o
40.0
00
CN
(D
Pu
0
0
Low Birth Weight
Anaemia
Fig 5
NEONATAL STATUS BY ANTENATAL CARE, COMPLICATIONS, ANAEMIA AND LOW BIRTH WEIGHT
FOR 15,221 CASES DELIVERED IN SELECTED MATERNITY CENTRES IN INDIA, JANUARY
1976 TO DECEMBER 1978
119
The maternal morbidity rates for all complications as well as for the antenatal,
intranatal and postnatal categories of complications were significantly
higher for stillbirths and neonatal deaths than for infants who were discharged
alive. These morbidity differentials were two to four fold (Fig 5). The incidence
__o. higher for• women with stillbirths (49.6%)
of anaemia was significantly
and neonatal deaths (40.1%) than for those with infants who were discharged alive
(27.2%) (Fig 5). The reported rates for prolonged/obstructed labour, placenta,
previa/abruptio, postpartum haemorrhage and retained products were also higher
for women with stillbirths and neonatal deaths than for those with infants
discharged alive. Anamolies and abnormalities were reported for the majority
of the stillbirths (93.8%) and neonatal deaths (75.5%) but for only 5.1 percent
of the infants discharged alive (Table VIII). The incidence of specific
anamolies/abnormalities was higher for neonatal deaths and stillbirths than for
infants discharged alive.
Mean gestational age was significantly higher for infants who were
discharged alive (38.0 weeks) than for stillbirths (34.8 weeks) and neonatal
deaths (32.4 weeks). Mean birth weight was also higher for infants discharged
alive (2711.1 grams) than for neonatal deaths (1747.9 grams) and stillbirths
(1969.3 grams) but the differences were not statistically significant.
The incidence of low birth weight (< 2500 grams) was significantly
higher for neonatal deaths (79.1%) and stillbirths (71.0%) than for infants
discharged alive (26.8%) (Fig 5).
Before This Delivery
After This Delivery
0.0
Other
] 2.8
2.0 [
Other
Conventionals
I15
5.3
pi
0.0
Vasectomy
0.0
Tubectomy
I 17.3
Orals
115.7
IUD
10.2
2.6
0.7
88.8
114.1
Condom
[
None
34.8
Fig 6
CONTRACEPTIVE ACCEPTANCE BEFORE AND AFTER DELIVERY FOR 15,158 WOMEN DELIVERED
IN SELECTED CENTRES IN INDIA, JANUARY 1976 TO DECEMBER 1978
120
Acceptance of Fertility Control Methods
While 88.8 percent of the couples had not used any method of fertility control
prior to the present delivery, only 34.8 percent did not agree to accept any
fertility control method after delivery. There was an increase in the acceptance
of all methods of fertility control except conventionals after delivery. Female
sterilisation (17.3%), oral contraceptive (15.7%) and condoms (14.1%) were the
most popular methods; IUDs were accepted by 10.2 percent cases (Fig 6).
DISCUSSION
The standard computer analysis from which this report is drawn , provides an
insight into a wide range of factors related to obstetric care at the institutions
utilising the Maternity Care Monitoring (MCM) System of the India FRP. .
Generally, young, low parity women attended these institutions which drew their
of this
clientele from urban and rural areas in the ratio of 3:2. The
S.- results
----- . were care
analysis showed that the key factors influencing pregnancy outcome
during the antenatal period, morbidity experience during pregnancy and delivery,
gestational age and birth weight. Women who did not receive any antenatal care
experienced significantly higher foetal and neonatal mortality. Significantly
higher complication rates were reported for women who had stillbirths and neonatal
deaths than for those whose infants survived. Survival rates were significantly
lower for infants with low birth weight and shorter gestational age . Nulliparous
women were clearly a high risk group. Significant parity differentials for
antenatal and intranatal complications were demonstrated. The incidence of
anaemia, the most common cause of maternal morbidity, was significantly higher
for multiparous women.
This analysis, not only describes the type of woman delivering at these institutions,
her obstetrical background and her morbidity and mortality experience, but
also substantiates the specific causes of maternal and neonatal morbidity in this
population, demonstrates the multiple interactions between the various influencing
variables and highlights the key factors such as parity, antenatal care, complication
rates, birth weight and gestational age which effect morbidity and mortality.
This feedback can be effectively utilised for defining priority problems for
this population of women and instituting appropriate control measures.
MCM may also be used as a research tool to scientifically explore areas of special
interest such as causes of maternal or perinatal morbidity and mortality in an
area, epidemiology of low birth weight (7,8), related aspects 'Of postpartum
contraceptive acceptance (9,10) obstetrical problems (11) and a host of other
unknowns in maternity care.
MCM permits evaluation of health indicators within institutions (6) or groups
of institutions (4,5) and when such feedback is periodic, the effect of control
measures on these health indices can be measured. Priorities may thus be
effectively reassigned based on scientific study of institutional data. In
addition to periodic evaluation within and between institutions, this system
may be used for making comparisons between maternity care programmes operating
in different parts of a country (10) and in different countries (2,12).
121
Thus, by incorporating the MCM system into service programmes, periodic,
computerized feedback can be obtained for the review and scrutiny of admini
strators, health staff and policy makers to enable them to focus on priority
tasks and effect appropriate measures for improving reproductive care and
pregnancy outcome.
ACKNOWLEDGMENT
The authors gratefully acknowledge the following contributors to the India Fertility
Research Programme who have carefully recorded the data from which this paper
is drawn: Drs. S.K. Banerjee, R.V. Bhatt, C.L. Jhaveri, M. Kochhar, A.C. Mehta,
S.P. Mehtaji, V.N. Purandare,D,N. Patel and Padma Rao.
REFERENCES
1. Bernard, R.P. Accounting of the reproductive process as derived from Maternity
Care Monitoring. Presented at the 8th International Scientific Meeting of the
International Epidemiological Association, San Juan, Puerto Rico, September
17-23, 1977.
2. Bernard, R.P., Kendall, E.M. and Manton, K.G. International maternity care
monitoring : A beginning. Presented at March of Dimes Symposium, Perinatal
Medicine: Present and Future Advances. Chicago, Illinois, April 4-5, 1978.
3. Bernard, R.P. Introducing maternity care monitoring in Egypt. Presented at
the 4th Annual Conference, Egyptian Fertility Control Society, Egypt Fertility
Research Programme Session, Cairo, Egypt, June 25, 1977.
4. Basu, S. Maternity care in India: An analysis of maternity cases in ten selected
hospitals. Fifth Transaction of Scientific Papers, India Fertility Research
Programme, p 106-110, 1978.
5. Rao, P. and Pachauri^
Pachawrz^ S.
Maternity profile - A comparison between a teaching
hospital and a non-teaching hospital in the same area. Fifth Transactions of
Scientific Papers, India Fertility Research Programme, p 118-121, 1978.
6. Bhatt, R.V., Pachauri, S. and Jamshedji, A.
Maternity care monitoring at the
Baroda Medical College Hospital. Sixth Transactions of Scientific Papers,
India Fertility Research Programme, p 78-92, 1979.
7. Caceres, E.M., Stewart, K.R. and Goldsmith, A.
and predictors of low birth weight.
The incidence^ complications
Int. J. Gynecol. Obstet. 16: 24-27, 1978.
8, Kohli, T.S., Mehtaji, S.P., Ramarao, R. and Batliwalla,
Batliwalla^ P R.
Low birth weight
Sixth Transactions of Scientific Papers, India Fertility Research
Programme, p 93-95, 1979.
babies.
9. Pachauri, S. and Jamshedji, A.
Fertility control practices among 15,221 women
undergoing hospital delivery. Indian Journal of Preventive and Social Medicine,
Vol. 10, No. 10, 63-68, June 1979.
122
10. Lewisj, J.A.. Contraception among women with obstetric deliveries and hospital
abortions in Tegucigalpa and San Pedro; Sula; Honduras; International Fertility
Research Program publication.
11. Lopez-Escobar; G.; Riano-Gamboa; G.; Fortney; J. and JanowitZ; B. Breech
presentations in a sample of Colombian hospitals. International Fertility
Research Program publication.
12. Bernard^ R.P.
International maternity care monitoring: Postpartum family
size expectation and contraceptive behaviour/service in Asia. Presented at
IPAVS Fourth International Conference; Seoul; Korea; May 7-10; 1979.
123
MATERNITY CARE MONITORING PROGRAMME OF THE CHRISTIAN
MEDICAL ASSOCIATION OF INDIA - EARLY EXPERIENCE OF
ONE HOSPITAL
H.M. Sharma, MBBS, BSSc, MPH1
Shanti Lail, MBBS2
ABSTRACT
Data on 1,226 women delivering 1,241 infants at the St. Catherine’s Hospitai,Kanpur, which is
one of the institutions participating in the Maternity Care Monitoring (MCM) programme
of the Christian Medical Association of India (CMAI) are reported. The standardized
and computerized system of the India Fertility Research Programme was utilised. Data
on sociodemographic characteristics, obstetric events, delivery, maternal and perinatal
mortality and morbidity, birth weight and postpartum fertility control acceptance are
described and discussed. MCM provides systematic feedback of reliable local data to
enable epidemiologic surveillance and peer review. MCM is a useful tool for programme
administrators as it assists in identifying priority problems and implementing costeffective measures to maximally benefit high risk groups of populations served.
INTRODUCTION
Maternity Care Monitoring (MCM) is a fast growing effort to design,test and adapt data
collection tools that can return information quickly to contributing centres and, in
doing so, help professionals in maternity care in developing countries to better manage
high risk mothers and infants before, during and after delivery (1). The Christian
Medical Association of India (CMAI) has undertaken a programme funded by the Church
World Service for implementing MCM in a sample of urban and rural institutions representing
all the major geographical zones in India. The India Fertility Research Programme
(India FRP) is monitoring and evaluating the project, This paper is a report from one
of the institutions included in the programme.
MATERIALS AND METHODS
Data on 1,226 women delivering 1,241 infants at the St. Catherine’s Hospital in Kanpur,
Uttar Pradesh, from February 1978 to December 1978 are reported. Data on sociodemographic
characteristics, obstetric history, management and outcome of delivery, antenatal complica
tions, complications of labour, delivery and puerperium and foetal/neonatal status
were recorded for consecutive deliveries using standard definitions and criteria nn
standard, single-page forms of the India FRP. ]For classifying antenatal conditions.
the 9th edition of the WHO International Classification of Diseases was used.
T----Director, Christian Medical Association of India Community Health & Family Planning Project,
Bangalore.
2
Medical Superintendent, St. Catherine’s Hospital, Kanpur, Uttar Pradesh.
124
Definitions and Criteria
All deliveries, regardless of outcome were included in the study. Induced and spontaneous
abortions with a foetus weighing less than 500 grams and gestation upto 19 weeks,
molar pregnancies and false labours were excluded. The duration of pregnancy was
estimated in completed weeks from the onset of the last normal menstrual period to the
day of the delivery. In the case of multiple antenatal and puerperal complications,
only the primary complications were reported. In the case of labour and delivery as
well as foetai/neonatal conditions both primary and secondary complications were reported.
Women with haemoglobin less than 10gm/100 ml were categorised as anaemic. For estimating
perinatal mortality rates, stillborn infants weighing 1000 grams or more and early
neonatal deaths were included. Neonatal death was defined as infant death prior to
discharge from the hospital. Fertility control acceptance as discussed in this study,
includes contraceptive methods planned and provided and, therefore, except in the case
of women undergoing concurrent sterilisation or IUD insertion there is no evidence
that the planned method was infact used. All statistical tests were performed using
a significance level (p value) of 0.05.
RESULTS
Sociodemographic Characteristics
The majority of the women attending this ceiitre for delivery were from urban (75.7%)
and urban slum (23.8%) areas; only 0.6 percent of the women were from rural areas.
The mean age of the women in this series was 25.4 years; 6.7 percent were below 20 and 4.3
percent were 35+ years of age. The mean number of living children was 1.2; 35.7 percent
had no living child and only 16.2 percent had three or more living children. The mean
educational achievement of these women was 9.6 school years; 39.9 percent had received
college education. Mean age at marriage was 19.1 years and mean duration of marriage was
6.7 years. The vast majority (92.9%) were booked cases. None of the cases were
admitted on an emergency basis (Table I).
Obstetric Events
The mean number of live births was 1.4. While 45.0 percent of the women had one to
two live births, 32,9 percent had no live births and only 18.5 percent had three or
more live births (Table II). The mean duration for which these women had breastfed
their infants was 11.7 months; about a third had breastfed their infants for more than
a year. In this series, 11.2 percent of the women reported infant losses. While 3.9
percent had experienced stillbirths, 15.3 and 2.5 percent respectively reported
spontaneous and induced abortions (Table II).
Antenatal Care
Only 7.2 percent of the women did not receive any antenatal care; 48.4 perceht had
one to three antenatal visits and 38.4 percent had four to seven antenatal visits
(Fig 1).
125
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 1,226 WOMEN DELIVERED AT THE ST CATHERINE’S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Sociodemographic Characteristics
Number
Percent
Age (Years)
4 19
20 - 24
25 - 29
30 - 34
35 - 39
40 +
Mean
82
535
424
131
52
2
6.7
43.6
34.6
10.7
4.2
0.1
Number of Living Children
0
1
2
3
4
5+
Unknown
Mean
438
358
187
107
60
32
44
Education (School years)
0
1-2
3-4
5-6
7-8
9 - 10
11 - 12
13 +
Unknown
Mean
153
5
20
137
173
248
180
309
1
Age at Marriage
<15
15 - 17
18 - 19
20 - 21
22 - 24
25 +
Unknown
Mean
93
334
333
265
145
53
3
Registration Status
Booked
Not booked
Referred by physician
25.4
35.7
29.2
15.3
8.7
4.9
2.6
3.6
1.2
12.5
0.4
1.6
11.2
14.1
20.2
14.7
25.2
0.1
9.6
7.6
27.2
27.2
21.6
11.8
4.3
0.2
19.1
1139
85
2
92.9
6.9
0.2
126
TABLE II
OBSTETRIC EVENTS .'OF 1,226 WOMEN DELIVERED AT THE ST. CATHERINE’S HOSPITAL,
KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Obstetric Events
Number
Percent
403
348
203
106
74
48
44
32.9
28.4
16.6
8.6
6.0
3.9
3.6
Live Births
0
1
2
3
4
5 4Unknown
Mean
1.4
Infant Deaths
0
1
2
34Unknown
Mean
1045
109
23
5
44
85.2
8.9
1.9
0.4
3.6
0.1
Stillbirths
0
1
2 4-
1177
41
8
Mean
96.0
3.3
0.6
0.05
Spontaneous Abortion
0
1
2 +
Mean
1038
139
49
84.7
11.3
4.0
0.2
Induced Abortion
0
1
2 4Mean
1195
24
7
97.5
2.0
0.5
0.03
127
50
Ef®!
38.4
c0)
o6
is
25
4-J
a0)
o
n
a)
Pm
6.0
7.2
0
0
1 -3
4-7
8+
Antenatal Visits
Fig 1
NUMBER OF ANTENATAL VISITS FOR 1,226 WOMEN DELIVERED AT THE ST. CATHERINE’S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
The Delivery
Mean duration of pregnancy was 39.2 weeks. Labour was spontaneous in 94.9 percent cases.
In 1.2 percent cases, labour was induced and 2.5 percent of the women did not go into
labour. While the presentation was vertex occiput anterior in the vast majority (95.3%)
of the cases, it was vertex occiput posterior in 1.2 and breech in 3.0 percent cases.
Delivery was spontaneous in 91.6 percent cases. Caesarian section was performed in
3.9 percent cases and breech presentation and forceps were employed in 2.8 and 1.5
percent cases respectively (Table III).
Caesarian section was performed for all cases with cephalopelvic disproportion and
placenta previa. However, it was performed only in 8.6 percent of the cases who had
prolonged obstructed labour. Most (70.8%) of the cases who had a previous history of
caesarian section underwent this procedure. Caesarian section was performed in 35.7
percent cases with foetal distress and 16.7 percent cases with toxemia. While all cases
with breech presentation were delivered vaginally, 42.9 percent with other malpresentations
underwent caesarian section. The majority (91.4%) of the cases with prolonged obstructed
labour and all cases with hypertensive disorders, diabetes, cord prolapse and premature
rupture of membranes were delivered vaginally (Table IV).
128
TABLE
III
TYPE OF LABOUR, PRESENTATION AND DELIVERY OF 1,226 WOMEN DELIVERED AT THE
ST. CATHERINE’S HOSPITAL, KANPUR, FEBRUARY 1978 TO
DECEMBER 1978
Number
Percent
Type of Labour
Spontaneous
Induced
No labour
Other
1122
15
30
15
94.9
1.2
2.5
1.3
Type of Presentation
Vertex occiput anterior
Vertex occiput posterior/transverse
Breech
Brow-face
Transverse lie
Other
1126
14
35
1
4
2
95.3
1.2
3.0
0.1
0.3
0.2
Type of Delivery
Spontaneous
Caesarian section
Breech extraction
Forceps
Manual rotation
1083
46
33
18
2
91.6
3.9
2.8
1.5
0.2
Labour/Presentation/Delivery
Note: Percentages are based on known cases only for this and all subsequent tables.
Data were not reported for 44 cases.
TABLE IV
INCIDENCE OF CAESARIAN SECTION AND VAGINAL DELIVERY AMONG CASES WITH INDICATION
FOR CAESARIAN SECTION FOR 1,226 WOMEN DELIVERED AT THE ST. CATHERINE'S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Indication
Previous caesarian section
Cephalopelvic disproportion
Placenta previa
Prolonged/obstructed labour
Breech presentation
Foetal distress
Malpresentation
Toxemia
Cord prolapse
Diabetes
Hypertensive disorders
Premature rupture of membranes
Other
No recorded conditions
TOTAL
Caesarian Section
No.
%
17
70.8
1
100.0
1
100.0
12
8.6
0
0.0
5
35.7
3
42.9
2
16.7
0
0.0
0.0
0
0.0
0
0
0.0
1
16.7
4
0.4
46
3.7
Vaginal Delivery
No.
%
7
29.2
0
0.0
0.0
0
127
91.4
34
100.0
9
64.3
4
57.1
10
83.3
100.0
1
100.0
1
4
100.0
100.0
31
83.3
5
99.6
947
1180
96.2
129
Maternal Morbidity
Antenatal complications were reported for 6.1 percent cases. Anaemia (2.8%) was the
most commonly reported complication. Pre-eclampsia and eclampsia were reported
for 1.1 and 1.0 percent cases respectively. Cephalopelvic disproportion and other
hypertensive disorders were each reported for 0.1 percent cases (Table V).
TABLE V
ANTENATAL COMPLICATIONS FOR 1,226 WOMEN DELIVERED AT THE ST CATHERINE'S HOSPITAL,
KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Antenatal Complications
Number
Percent
32
12
11
1
1
1
12
2.8
1.1
1.0
0.1
0.1
0.1
1.1
70
6.1
Anaemia
Preeclampsia
Eclampsia
Cephalopelvic disproportion
Other hypertensive disorders
Diabetes
Other
TOTAL
\
Note: Data were not reported for 85 cases.
The incidence of complications reported during labour and delivery was 19.9 percent.
Prolonged obstructed labour (12.0%) was, by far, the most frequently reported complica
tion. Haemorrhage and retained products were reported for 2.2 and 0.8 percent cases
and placental previa and cord prolapse were each reported for 0.2 percent cases
(Table VI).
TABLE VI
COMPLICATIONS OF LABOUR/DELIVERY REPORTED FOR 1,226 WOMEN DELIVERED AT THE
ST. CATHERINE"S HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Complications
Prolonged/obstrueted labour
Haemorrhage
Retained products
Placenta previa
Cord prolapse
Hypertonia uterine contractions
Other
TOTAL
Note: Data are not reported for 44 cases.
Number
Percent
142
26
10
2
3
1
51
12.0
2.2
0.8
0.2
0.2
0.1
4.3
235
19.9
Puerperal conditions were reported for 4<4 cases, The incidence of fever requiring
antibiotics was 4.1 percent. Bleeding requiring treatment was reported for 2 (0.2%)
cases and phelebitis for 1 (0.1%) case (Table VII).
TABLE VII
PUERPERAL CONDITIONS REPORTED FOR 1,226 WOMEN DELIVERED AT THE ST. CATHERINE’S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Puerperal Condition
Fever requiring treatment
Bleeding requiring treatment
Phlebitis
TOTAL
Numb er
Percent
49
2
1
4.1
0.2
0.1
52
4.4
Note: Data were not reported for 44 cases.
The incidence of antenatal complications was significantly higher for women of 35+
(21.3%) years of age than for those who were 18 to 34 (5.4%) years of age. Women below
18 years (12.5%) had a higher complication rate than those who were 18 to 34 years of
age but the difference was not statistically significant. Complication rates during
labour and delivery were higher for women under 18 years (22.2%) than for those who were
18 to 34 years (17.5%) and 35+ years of age (9.6%), but the difference was not statitically
significant. No puerperal conditions were reported for women under 18 years of age,
The incidence of puerperal conditions was similar for women in the 18 to 34 (4.5%) and 35+
years groups (3.8%) (Fig 2).
□
18-34
30
w
c
o
•H
0
□
22.2
35+
21.3
cQ
O
•H
<3
Maternal Age(Years)
< 18
15
12.5
9.6
a
o
OJ
Pm
5.4
4.5
0.0
IE
3.8
0
Antenatal
Complications
Complications of
Labour/Delivery
Puerperal
Condition
Fig 2
MATERNAL AGE BY COMPLICATIONS REPORTED FOR 1,226 WOMEN DELIVERED AT THE
ST. CATHERINE’S HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Antenatal complications rates were significantly higher among grandmultiparas (16.0%)
and multiparas (5.4%), Primiparas (27.9%) had significantly more complications during
labour and delivery than multiparas (12.0%). However, the difference in complication
rates during labour and delivery between multiparas (12.0%) and grand multiparas
(10.9%) were not statistically significant. The incidence of puerperal conditions
was significantly higher for primiparas (6.6%) than for multiparas (3.3%). However,
the difference in the incidence of puerperal conditions between grand multiparas (5.4%)
and primiparas (6.6%) was not statistically significant (Fig 3).
Primiparas
Muitiparas
30
2 7.9
□
w
C
o
Grand multiparas
•r4
aJ
o
ex
S
o
o
16.0
15
10.9
........ Sy////.------*zzzz>
a(D
6.1 ,5.4
o
’
<77775
a)
ex
ZZZZZZ
zzzzzz
ZZZZZZ
<<<<<<
Antenatai
Complica tions
0
’ZZZZ.
’ZZZZ.
’ZZZZ/
'ZZZZ>
’ZZZZ>
•ZZZZ/
ZZZ//
ZZZZ/
ZZZZ,
Complications of
Labour/Delivery
6 .6
I
5.4
3.3 r—
Puerperal
Condition:
Fig 3
PARITY BY COMPLICATIONS REPORTED FOR 1,226 WOMEN DELIVERED AT THE ST. CATHERINE’S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Neonatal/Foetai Conditions
Foetal/neonatal conditions were reported for 6.0 percent cases. Foetal distress during
labour and respiratory distress after delivery were reported for 3.0 and 0.5 percent
cases. Major malformations were reported for 4 (0.3%) and minor malformations for 3
(0.2%) infants (Table VIII). Significantly higher rates for foetal/neonatal conditions
TABLE VIII
FOETAL/NEONATAL CONDITIONS FOR 1,226 WOMEN DELIVERED AT THE ST. CATHERINE’S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Condition
Foetal distress during labour
Major malformations
Respiratory distress
Minor malformations
Trauma
Other
TOTAL
Number
Percent
36
4
6
3
1
21
3.0
0.3
0.5
0.2
0.1
1.8
71
6.0
132
were reported for grandmultiparas (12.7%) and multiparas (3.4%). The incidence was
higher for primiparas (8.4%) than for multiparas (3.4%) but the difference was not
statistically significant. The incidence of foetal distress during labour (3.0%)
was significantly higher for primiparas (5.6%) than for mulitparas (1.5%).
40
36^5
33.5
w
a
<4-J
-U
aa)
o
20
13.7
0)
fX|
9.7
4.5
2.0
0
r—<
V
<r
CM
OJ
I
I
co
I
co
I
+
o
o
o
Birth Weight
Fig 4
BIRTH WEIGHT OF 1,241 INFANTS DELIVERED AT THE ST. CATHERINE’S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Birth Weight
Mean birth weight for the study group was 2941.6 grams. In this series, 18.2 percent
of the infants weighed less than 2500 grams and 4.5 percent weighed less than 2000
grams (Fig 4). Mean birth weight was significantly lower for women below 18 years
of age (2458.9 grams) than for those who were 18 to 34 (2943.2 gms) and 35+ (2992.1 gms)
years of age (Fig 5). Mean birth weight of infants born to primiparas (2721.6 gms)
was significantly lower than of those born to multiparas (3001.9 gms) and grand
multiparas (3071.8 gms) (Fig 5).
133
■
3000
pm yy r.
'ZZZZ/
'Z^ZZ?
'zzzz/
'zzzz/
'ZZZZ/
w
S
’zzZz/
d
e
60
(D
2500
'Z//Z?
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
'ZZZZ/
7////
7/////
'/////
'/////
'/////
'/////
'/////
'/////
'/////
'ZZZ//
'/////
f/7/7
PQ
'/////
'■777
c
cd
(D
s
’/////
>/////
'/////
'/////
' zzzzz
t/ / / / /
'zzzzz
’/////
2000
'/////
'/////
7/////
'/////
'/////
iw
< 18
18 - 34
35+
0
1 - 4
' z zzz.
'ZZZZ.
'ZZZZ.
'ZZZZ.
-'Z zzz,
7////
7/7/
/////<
/////.
/////.
' / / / /.
/////.
'////.
/////.
/////.
/////.
/////.
/////.
7
//z
/////.
/////.
/////.
/////.
'////.
77/7Z
/////.
7////
//////.
/ / / /.
' / / //,
/////.
/////.
/////.
/////»
/////.
/////»
/////.
/////,
/ / / / /1
7//7/.
7/77
//////*
/////t
11 /11 <
5+
Parity
Maternal Age (Years)
Fig 5
MEAN BIRTH WEIGHT BY MATERNAL AGE AND PARITY FOR 1,224 WOMEN DELIVERED
AT THE ST. CATHERINE’S HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Neonatal deaths were reported for 11.1 percent of the low birth weight infants with
foetal distress in labour; only 1 (2.8%) weighing 2500+ grams died subsequent to
foetal distress during labour. The incidence of low birth weight (< 2500 gms) was
75.0, 68.2 and 16.0 percent for stillbirths, neonatal deaths and infants discharged
alive; the incidence of low birth weight (<2000 gms) was 50.0, 45.4- and 2.9 percent
respectively.
Mortality
There were two maternal deaths, The maternal mortality rate was 1.7 per 1000 live
births. There were 17 reported etillbirths; of these 16 deaths occurred during the
antepartum period and one during labour/delivery. The stillbirth and neonatal mortality
rates were 13.7 per 1000 infants delivered and 18.0 per 1000 live births respectively.
The perinatal mortality rate was 31.4 per 1000 infants delivered (Table IX).
134
TABLE IX
MORTALITY RATES REPORTED FOR 1,226 WOMEN DELIVERED AT THE ST. CATHERINE’S
HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
Mortality
Number
Percent
Maternal mortality
Stillbirths
Neonatal mortality
Perinatal mortality
2
17
22
39
1.7
13.7
18.0
31.4
Note: 1. Maternal and neonatal mortality rates are expressed per 1000
live: births arid the stillbirth and perinatal mortality rates
per 1000 infants delivered.
2. Neonatal mortality includes deaths before discharge to infants
born alive and perinatal mortality included neonatal deaths plus
stillbirths weighing at least 1000 grams.
After
Before
0.0
Female
Sterilisation
3.3
0.0
Vasectomy
1.1
3.1
0.4
11.9
1.7
34.9
Orals
IUD
5.6
26.7
Condom
Conventionals
1.8
26.7
82.9
None
Fig 6
CONTRACEPTIVE PRACTICE OF 1,226 WOMEN BEFORE AND AFTER DELIVERY AT THE
ST. CATHERINE’S HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
135
Postpartum Fertility Control
While 82.9 percent of the women had not used any method of fertility control before
delivery, 73.3 percent accepted a method after delivery. Oral contraceptives (34.9%)
and condoms (26.7%) were the most popular methods with this group; 3.3 percent of the
women and 1.1 percent of the husbands underwent sterilisation (Fig 6). In this series,
53.3 percent of the women stated that they did not desire additional children. However,
only 8 percent of the cases accepted a permanent method of fertility control; 59.7
percent accepted a temporary method, This focusses the need to concentrate efforts on
motivating this group of cases.
Mo ther^-in-law
Family Size
Husband
None
Pzzzzzzi
rzzzzzz,
r zzzzz/,
rzzzzzz
r/z/zzz
Irzzzzzz
•.W-’.W.V.'.V.".".
kzzz/zz
rzzzzzz
rzzzzzz
I 17.0%
69.0%
ZZZZZZ/
ZZZZZZz
ZZZZZZ/
ZZZZZZ/
IZZZZZZZ
ZZZZZZZ
ZZZZZZZ
ZZZZZZZ
ZZZZZZZ
w.'.w.v.v
Contracep tives
17.4%
13.6%
68.9%
13.7%
Fig 7
DISCUSSION OF FAMILY SIZE AND CONTRACEPTIVES BY 1,226 WOMEN DELIVERED AT THE
ST. CATHERINE’S HOSPITAL, KANPUR, FEBRUARY 1978 TO DECEMBER 1978
While 69.0 percent of the women reported having discussed family size with their husbands
17.0 percent discussed this with their mothers-in-law and 13.6 percent reported that
they did not discuss this with anyone. Methods of fertility control were discussed
with the husbands and mothers-in-law by 68.9 and 17,4 percent women respectively;
13.7 percent did not discuss contraceptive methods with anyone (Fig 7).
136
COMMENT
This analysis provides sociodemographic and clinial baselines for maternity care provided
at the hospital from which these data are drawn. The average woman who booked for
delivery at this urban institution, was young and of low parity. She was fairly well
educated and had received some antenatal care. Having married at the age of nineteen,
she has been married for an average of six to seven years and although, in most cases,
she had not used any method of fertility control before delivery, she generally
accepted a temporary method of contraception after delivery. This analysis identifies
the high risk groups of mothers and newborns, specifies the causes of maternal and
perinatal morbidity and highlights the centre’s policies for hospitalisation and for
electing caesarian section and other methods for delivery. Similar baselines will be
available for other CMAI institutions implementing MCM. With continued participation
in the programme, periodic epidemiological analyses to evaluate performance of
various participating institutions and to measure progress over time will become
available.
MCM has the potential for reversing the ’top-down’ planning process by stimulating
the active involvement of those who are responsible for service delivery through
peer review and discussion. It increases awareness, responsibility and accountability
of service providers and links services in a referral system to the various levels
of organized maternity care (2-3). By providing periodic, systematic feedback of
such data, MCM permits evaluation of health indicators within institutions (4) and
group of institutions (3,5,6) and when such feedback is periodic, the effect of
control measures on these health indices can be measured. Priorities may thus be
effectively assigned and reassigned based on scientific study of institutional data.
This system may also be used for making comparisons between maternity care programmes
operating in different parts of a country (3) and in different countries (1,2,7).
The authors propose to analyse data from several other CMAI institutions, Pooled
analyses of these data will provide an overview of programme performance, By comparing
results for similar institutions through this standardized system, differences in
performance- will be highlighted and the causes of such difference will be studied.
Comparisons will also be made between urban and rural institutions as well as those
in different geographical regions of the country. Continued epidemiologic surveillance
by MCM will enable programme planners and service providers to formulate and implement
measures for tackling priority problems to maximally benefit high risk groups served
by these institutions.
137
References
1, Bernard^ R.P.j Kendall, E.M. and Manton, K.G. International maternity care monitoring:
A beginning. In: Clinical Perinatology, 2nd ed., A. Aladjem, A.K. Brown and C. Bureau,
eds. St. Louis, Q V. Mosby & Co. p 521-559, 1980.
" E.^ Maternity care monitoring
2. Bernard, R.P., Kendall, E.M., Peng, J.Y. and Kessel,
at ''the IFRP/IGCC East and South East Asia Seminar on
(MCM): Where next? Presented
x----Regional Fertility Research, Bangkok, Thailand, July 18-20, 1979.
3. Pachauri, S. and Jamshedji, A. Maternity Care monitoring: A comparison of nine centres.
Scientific Papers of the India Fertility Research Programme, p 138-165,1980.
4. Bhatt, R.V., Pachauri, S. and Jamshedji, A. Maternity Care monitoring at the Baroda
Medical College Hospital. Fifth Transactions of Scientific Papers, India Fertility
Research Programme, p 78-92, 1979.
5. Rao, P. and Pachauri, S. Maternity profile: A comparison between a teaching, hospital
and a non-teachning hospital in the same area. Fifth Transaction of Scientific
Papers, India Fertility Research Programme, p 118-121, 1978.
6. Pachauri, S. and Jamshedji, A. Maternity care monitoring: An illustration from-India.
Scientific papers of the India Fertility Research Programme, p 104-122, 1980.
7. Bernard, R.P. International maternity care monitoring: Postpar turn family size
expectation and contraceptive behaviour/service in Asia. Presented at IPAVS Fourth
International Conference, Seoul, South Korea, May 7-10, 1979.
138
MATERNITY CARE MONITORING ; A COMPARISON OF NINE CENTRES
Saroj Paehauri,
DPH3
Armzn Jcons'hedjij MA
o
ABSTRACT
This paper describes the concept, scope and utilisation of the system for Maternity
Care Monitoring (MCM) in service programmes. Data from nine centres are displayed
on the abacus in a ranked manner, to show inter-centre differentials and to demonstrate
associations between interrelated variables. Sociodemographic characteristics,
mortality, morbidity, birth weight and postpartum fertility control acceptance are
described. In the context of limited resources in developing countries, priorities
must be clearly defined to ensure the appropriate allocation and optimal utilisation
of available resources. This requires that an efficient monitoring system be built
into service programmes so that present needs can be adequately assessed and future
trends anticipated and planned for thorough continuous measurement and evaluation.
The scope of MCM as a managerial and research tool for service providers and programme
planners and as a means for providing referral linkages and staff supervision and
training is discussed.
INTRODUCTION
In developing countries today, problems of high priority that need urgent attention
are those related to the reduction of maternal and perinatal mortality and morbidity.
To effectively combat these problems with limited available resources, it is imperative
that programme priorities be clearly defined, evaluated and redefined, on a continual
basis. An essential pre-requisite for this is an efficient system of monitoring which
establishes sociodemographic and clinical baselines and provides periodic examination
of indices of maternal and infant health. The standardized and computerized system for
Maternity Care Monitoring (MCM) developed by the International Fertility Research Program
(IFRP) in association with the International Federation of Gynecology and Obstetrics
(FIGO) has been extensively pretested and is operational in several countries. Results
to date indicated its potential internationally as a management tool (1-3).
The International Federation for Family Health (IFFH) is assisting its member countries
to incorporate MCM within their service programmes. MCM enables the evaluation of
maternity services and provides regular, systematic feedback of pertinent information
to service providers and programme planners to enable them to implement appropriate
and effective, measures for improving maternity services on a continual basis. By providing
sensitive indices which highlight important gaps in service delivery, MCM enables
identification of priority areas for action at various service levels. This concept
has the potential for stimulating peer review and discussion by service providers and,
thereby, creating initiative for planning of service strategy by those responsible
for providing services.
MCM is presently operational in more than thirty five institutions in India. In this
paper data are reported from nine institutions with the objective of demonstrating the
scope and utilisation of MCM within a country and documenting the methodology recommended
by Bernard et al for comparing the service performance of various institutions (4).
^Prelect Director,
Hyderabad.
3^Research Assistant, International Maternity Care Monitoring Project,
139
MATERIALS AND METHODS
Data are reported on 14,043 women delivering 14,364 infants at nine centres in
India from January 1977 to December 1978. All these institutions utilised the
computerized and standardized MCM system of the India Fertility Research Programme
(India FRP). Data on sociodemographic characteristics, obstetric history, antenatal,
inLranatal and postnatal status of the mother, management and outcome of delivery and
neonatal status were recorded using standard definitions and criteria on standard,
single page forms of the India FRP.
Definitions and Criteria
All deliveries, regardless of outcome were included in the study. However, induced
and spontaneous abortions (with a foetus weighing less than . 500 grams and gestation
upto 19 weeks), molar pregnancies and false labour were excluded. The duration of
pregnancy was estimated in completed weeks from the onset of the woman’s last normal
menstrual period to the day of delivery.
In cases with multiple complications, only the primary complication was reported.
Women with haemoglobin less than 10 grams per 100 ml were categorized as anaemic.
For defining low birth weight, 2500 grams and 2000 grams were taken as cut-off points.
For estimating mortality rates, stillbirths weighing 1000 grams or more and early
neonatal deaths were included. Neonatal death was defined as infant death prior to
discharge from the hospital. Mean postdelivery hospitalisation at the study centres
ranged from 3.4 to 7.0 nights. Reported rates are lower for centres where women were
discharged before 7 days of delivery and so the reported perinatal mortality rates
do not include all deaths within 7 days of birth.
Except in the case of women who underwent sterilisation or IUD insertion during
their hospital stay, postpartum contraception as reported in this paper, reflects
the couples’ intention to contracept and not the actual use of the contraceptive
me thod.
Methodology
I.
■
As recommended by Bernard et al, the authors have utilised the abacus to show the
results of MCM at the study centres and have displayed the findings in a ranked
manner (4). This method is recommended for evaluating and comparing centre performance
as it provides a simple means for highlighting inter-centre differences. As these
differences are seen by the service providers, peer review and discussion are stimulated
and consequently recommendations for action are initiated from within the group that
is responsible for service delivery. The centres from which data are reported
in this paper were not essentially similar in character or locale as is frequently
reflected in the findings. However, the objective of this paper is not to report
the findings per se but to illustrate the methodology.
140
In this paper, the authors have further extended the use of this methodology by
utilising the abacus to not only show the inter-centre differentials, but also to
demonstrate associations between two or more variables. To do this, one variable,
generally the independent variable is first ranked in descending order, by centre.
When this is done, the range of this variable as well as the high and low ranking
centres are immediately visualised. Next, the corresponding values for the dependent
variable are plotted for each centre. A consistent association between variables
plotted on the abacus is suggestive of a statistically significant correlation. In
this analysis, apparent associations observed on the abacus, were statistically
validated. The correlation coefficients for the corresponding variables were found
to be statistically significant in the vast majority of the cases. The significant
level (p value) of 0.05 was used.
RESULTS
Sociodemographic Characteristics
Generally young (mean age 25.7 years), low parity (mean 1.2) women attended these
institutions which drew their clientele from urban and rural areas in the ratio of
3:2. Age and parity differentials between centres were minimal (Table I and Fig 1).
A similar pattern of increasing parity with increasing maternal age was seen at all
centres. Parity increased from 0.2 - 0.5 at < 19 years, to 1.5 - 3.4 at 35 - 39
years, and 0.0 - 4.0 at 40+ years. In one centre, however, higher parity levels were
noted for each age group; 4.9 at 35 — 39 years and 6.3 at 40+ years (Fig 2). Uiis
difference was probably due to the fact that this centre derived its clientele pre
dominantly from rural areas. The educational level of women delivering at these
centres differed widely and ranged from 1.4 to 13.1 mean school years (Table I).
TABLE I
MEAN AGE, PARITY AND EDUCATION OF WOMEN DELIVERED AT NINE CENTRES
IN INDIA, JANUARY 1977 TO DECEMBER 1978
Centres
No. of Cases
Mean
Age
Mean
Parity
Mean
Education
Bombay (1)
Bombay (2)
Bombay (3)
Bombay (4)
Bombay (5)
Baroda
Manipal
Delhi
Calcutta
2874
1673
1234
729
907
3388
1851
904
483
25.4
25.4
26.4
25.3
26.9
25.0
27.0
24.9
25.6
1.2
1.2
1.3
1.2
0.8
1.4
1.7
1.3
1.1
1.4
4.4
8.7
3.4
13.1
4.6
5.7
4.7
8.3
Note: In the figures these centres are designated as follows: Bombay 1-5 as
B1-B5, Baroda as Bd, Manipal as M, Delhi as D and Calcutta as C.
TABLE II
PRESENT AND PAST MATERNAL AND PERINATAL LOSSES FOR WOMEN DELIVERED
AT NINE CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
Perinatal
Mortality
Rate/1000
Stillbirth*
Infant Mortality*
Rate/1000
Rate/1000
Rate/1000
Rate/1000
Neonatal
Mortality
Rate/1000
Bombay
3.6
24.8
18.8
44.4
10.7
11.6
Bombay2
1.9
27.3
39.0
65.2
13.5
21.5
Bombay
1.7
15.3
15.5
30.6
12.0
6.0
Bomb ay 4
0.7
16.2
33.0
48.7
18.6
23.8
Bombay 5
0.8
11.0
4.5
15.4
18.9
46.8
Baroda
7.8
67.0
48.0
111.9
19.8
45.5
Manipal
1.7
26.7
14.8
41.1
28.4
33.9
Delhi
0.9
29.5
0.0
31.7
16.5
28.4
Calcutta
2.2
30.4
41.8
70.9
17.0
15.1
Centres
Maternal Mortality
Stillbirth
Note: 1. Maternal and neonatal mortality rates are expressed per 1000 live births and the stillbirth and perinatal
mortality rates per 1000 infants delivered.
2. Neonatal mortality includes deaths before discharge to infants born alive and perinatal mortality includes
neonatal deaths plus stillbirths weighing at least 1000 grams.
* These rates pertain to past deliveries,
deliveries.
The stillbirth and infant mortality rates are expressed per 1000
142
Mortality
While there were wide mortality differentials between centres, most of the centres
that had a higher incidence of maternal deaths also had a higher incidence of still
births and neonatal deaths (Table II and Fig 3). However, although the maternal
mortality and stillbirth rates correlated ( r +.90) significantly, these variables
did not correlate significantly with the neonatal death rate.
A positive association was observed for prior infant deaths and stillbirths (Fig 4),
however, the correlation coefficient (r +.64) was not statistically significant.
While infant mortality rates varied considerably between centres (6.0 -46,8 per 1000
deliveries), the stillbirth differentials were not so marked (10.7 - 28.4 per 1000
deliveries) (Table II and Fig 4).
Morbidity
There was a wide variation in the incidence of antenatal (4.4% - 57.5%) and intranatai
complications (7.4% - 23.7%) between centres. The incidence of postnatal complications
ranged from 0.5% to 11,1%. Centres reporting a higher incidence of antenatal
complications also reported a higher incidence of intranatal and postnatal complications
(Table III and Fig 5). However, the correlation coefficient (r +.80) was significant
for intranatal and postnatal complications. Figure 5 shows a positive association
for perinatal mortality and maternal morbidity. The correlation coefficients for
perinatal mortality rate and antenatal (r +.62), intranatal (r +.26) and postnatal
(r +.07) complication rates were, however, not statistically significant.
TABLE III
MATERNAL MORBIDITY RATES REPORTED FOR WOMEN DELIVERED AT NINE CENTRES IN
INDIA, JANUARY 1977 TO DECEMBER 1978
Percent Complications
Centres
Bombay (1)
Bombay (2)
Bombay (3)
Bombay (4)
Bombay (5)
Baroda
Manipal
Delhi
Calcutta
Antenatai
Intranatai
Postnatai
18.9
14.9
4.4
6.3
57.5
52.1
12.7
7.0
34.1
7.7
4.8
7.4
6.6
23.7
11.5
15.6
17.2
19.8
2.8
1.6
1.5
0.5
8.8
2.4
3.1
2.5
11.1
Note: In the case of multiple antenatal, intranatai and postnatal complications
only the primary complications are reported.
143
35+
5+
-34
4
-29
3
ft)
CD
(D
OD
hd
CD
C
<D
s
H-
-24
2
-19
1
15
0
M
B5
B3
C
Bl
B4
Bd
B2
D
Fig 1
MEAN MATERNAL AGE AND PARITY FOR WOMEN DELIVERED AT NINE CENTRES
IN INDIA, JANUARY 1977 TO DECEMBER 1978
£
7.0
3.5
£
£
0
19
20-24
25-29
30-
Maternal Age (Years)
Fig 2
MATERNAL AGE BY MEAN PARITY FOR WOMEN DELIVERED AT NINE CENTRES IN
INDIA, JANUARY 1977 TO DECEMBER 1978
145
70
o
o
o
ft
35
’"•4
0J
3
^4
K.
i
o
■■■■■I !■■■■■
Bd
C
D
B2
M
Bl
B4
■■■■
J
B3
B5
Fig 3
MATERNAL AND NEONATAL MORTALITY RATES AND STILLBIRTH
RATES REPORTED FOR WOMEN DELIVERED AT NINE
CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
i
i
146
60
4?
%
X
o 30
o
o
0)
>
—
4J
OJ
'i
StUl
b^tfl
-"Nt
0
B5
Bd
M
D
B4
B2
c
Bl
B3
Fig 4
PREVIOUS INFANT MORTALITY RATES AND STILLBIRTH RATES REPORTED BY
WOMEN DELIVERED AT NINE CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
147
80
100
60
40
•-d
CD
K
c
o
3
03
U
rf
0)
Q-
s
u
o
o
0)
11
p4
aa)
o
a)
50
0
I
PL<
(D
G
20
o
o
o
* I
o
T
0
0
B5
>4
rost7^
'I'
Bd
"ifi,
C
Bl
■■■■if
b2
M
//G
: 1 .f
D
B^
co
0
B3
Fig 5
MATERNAL MORBIDITY RATES AND PERINATAL MORTALITY RATES FOR WOMEN
DELIVERED AT NINE CENTRES IN INDIA, JANAURY 1977 TO DECEMBER
1978
148
60
VV.
K
U)
c
o
aJ
o
$
30
•A
CU
e
o
u
c
o
o
0)
PU
0
B5
Bd
C
B1
B2
M
B4
i
D
b3
Fig 6
ANTENATAL COMPLICATION RATES REPORTED FOR PRIMIPAROUS AND
MULTIPAROUS WOMEN DELIVERED AT NINE CENTRES IN INDIA,
JANUARY 1977 TO DECEMBER 1978
I
149
50
■ V
c
o
d
o
t
a
6
o
u
25
ni
aj
C
aJ
N
5-4
■U
a
n
4-»
a
.....
•t
<D
u
0)
...
^Urii
• I»11111
0
B5
M
C
D
Bd
b4
B1
b3
b2
Fig 7
INTRANATAL COMPLICATIONS REPORTED FOR PRIMIPAROUS AND MULTIPAROUS
WOMEN DELIVERED AT NINE CENTRES IN INDIA, JANUARY 1977 TO
DECEMBER 1978
1
150
70
K
II
> F
V'
d
oe
-5
*
35
c
O
0)
Pu
D
b2
1
Fig 8
INCIDENCE OF ANAEMIA IN PRIMIPARAOUS AND MULTIPAROUS WOMEN DELIVERED
AT NINE CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
151
20
<D
(D
>
(D
Q
k
Q0)
O
*
-
o
P-t
*
'c
V
o
U
(V
cn
C
wf-
05
10
03
w
o
05
O
C
0)
O
3-4
0J
PU
0
C
85
b3
Bd
M
81
84
82
D
Fig 9
THE INCIDENCE OF CAESARIAN SECTION AND FORCEPS DELIVERIES FOR
WOMEN DELIVERED AT NINE CENTRES IN INDIA, JANUARY 1977
TO DECEMBER 1978
!lS(
j
152
60
3100
x.
£
%
4V
X.
cn
<D
W
2
(D
Pi
5
W
1/
<3 30
4-»
a
0)
2800
fD
H*
OQ
o
0)
PH
z
A
X
K
Tri
.. r“r'4>~$
■■■mi in
■ Hill
0
Bd
b2
B4
Bl
D
C
B3
M
2500
B5
Fig 10
MEAN BIRTH WEIGHT AND PERCENTAGE OF LOW BIRTH WEIGHT INFANTS
DELIVERED AT NINE CENTRES IN INDIA, JANUARY 1977 TO
DECEMBER 1978
I
153
3000
■M
60
<D
2500
■■■■in
PQ
C
CD
S
2000
b5
M
b3
C
D
Bl
B4
Bd
B2
Fig 11
MEAN BIRTH WEIGHT FOR PRIMIPAROUS AND MULTIPAROUS WOMEN DELIVERED
AT NINE CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
154
3000
GO
0)
42
2500
6
nJ
0)
S
2000
B5
M
b3
D
B1
b4
b2
Bd
C
Fig 12
MEAN BIRTH WEIGHT FOR ANAEMIC AND NON-ANAEMIC WOMEN DELIVERED
AT NINE CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
J
155
3000
110
►
n>
K
H«
3
0)
0)
rs
rt
CO
K
M)
2800
80
%
U
rr
PQ
ss
TJ
(D
ri
o
o
o
0
2400
b5
M
b3
D
b4
C
Bl
B2
Bd
Fig 13
MEAN BIRTH WEIGHT AND PERINATAL MORTALITY FOR WOMEN DELIVERED
AT NINE CENTRES IN INDIA,* JANUARY 1977 TO DECEMBER 1978
156
100
1001
rt>
K
CU
K
W
co
(U
co
OJ
u
50
50
X.
c
r?
XJ
O
5^
0)
o
o
o
cu
X
r%.
"•Ki
Lliii
I
0
x:
Birth Weigh <-
Bd
I
B2
I " Z(j00 8ms
Bl
C
B4
D
B3
M
B5
Fig 14
THE INCIDENCE OF LOW BIRTH WEIGHT AND PERINATAL MORTALITY FOR
INFANTS DELIVERED AT NINE CENTRES IN INDIA, JANUARY 1977
TO DECEMBER 1978
0
157
80
: -
Vx
%
0)
oco
40
c
0)
o
(V
P-.
.4
Sterilisa :ion
11111 11111 inn
..
o.... .
■&> • 111111
0"
e
kA
0"
top
I
0
B5
C
Bd
B3
D
Bl
b2
M
b4
Fig 15
POSTPARTUM ACCEPTANCE OF PERMANENT AND TEMPORARY
METHODS OF FERTILITY CONTROL AND NON-ACCEPTANCE
OF FERTILITY CONTROL METHODS BY WOMEN WHO HAVE
COMPLETED THEIR DESIRED FAMILY SIZE AT NINE
CENTRES IN INDIA, JANUARY 1977 TO DECEMBER
1978
I
158
20.0
w
co
nJ
o
0)
■u
10.0
G
O
o
PU
0
b3
B2
M
Bl
Bd
C
B4
B5
D
Fig 16
FEMALE AND MALE STERILISATION ACCEPTED BY WOMEN DELIVERED AT
NINE CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
159
¥
IUD
Condom
____
0
25
Percent Cases
50
0
25
Percent Cases
50
0
25
Percent Cases
Orals
0
25
Percent Cases
No Contraceptive Acceptance
0
50
Percent Cases
100
Fig 17
POSTPARTUM ACCEPTANCE OF THE CONDOM, STERILISATION, ORAL CONTRACEPTIVES
AND IUD AND NON-ACCEPTANCE OF FERTILITY CONTROL METHODS AT NINE
CENTRES IN INDIA, JANUARY 1977 TO DECEMBER 1978
50
160
The incidence of antenatal complications was similar among primiparas and multiparas
(Fig 6). However, the incidence of intranatal complications was consistently higher
for primiparas at all study centres (Fig 7). The incidence of anaemia was higher
for multiparas than for primiparas (Fig 8). Although the incidence of caesarian
section and forceps delivery varied markedly between centres there was a statistically
significant positive correlation (r +.79) between these two methods of delivery (Fig 9).
Birth Weight
Mean birth weight ranged from 2527.9 grams to 2915.4 grams and the incidence of low
birth weight infants ranged between 3.6% and 11.0% for<2000 grams and from 5.4% to
42.5% for < 2500 grams at the study centres (Fig 10). As expected, highly significant
negative correlations were noted for mean birth weight and incidence of low birth
weight infants of < 2000 grams (r -.92) and < 2500 grams (r -.98) (Fig 10). Mean
birth weight of infants born to primiparous women was lower than that of infants born
to multiparous women (Fig 11) and mean birth weight for infants of anaemic women was
lower than that for infants of non-anaemic women (Fig 12). These differentials were
consistently evident at all centres.
Reported perinatal mortality rates ranged from 15.4 to 111.9 per 1000 infants delivered
at the various centres. A statistically significant inverse correlation (r -.79)
was demonstrated between perinatal mortality rates and mean birth weight (Fig 13).
Similarly, centres with a higher incidence of low birth weight infants reported higher
perinatal mortality rates (Fig 14); the correlations with perinatal mortality were
highly significant for'infants weighing < 2500 grams (r -.75) and <2000 grams (r -.86).
Postpartum Contraceptive Acceptance
There were wide variations in the acceptance of postpartum contraception (21.0% to
74.9%) at various centres. The proportion of couples who stated that they had completed
their desired family size but who did not accept any method of fertility control ranged
from 0.0 to 33.3 percent at various centres (Fig 15). The percentage of couples
accepting temporary methods ranged from 20.3% to 74.0%. While sterilisation acceptance
was similar at most centres (Fig 15), female sterilisation was accepted more frequently
than male sterilisation at all centres (Fig 16). Figure 17 shows that condoms were
accepted by 0.0 to 26.5%, IUDs by 0.0 to 28.6% and oral contraceptives by 2.6 to 35.1
percent couples at the various centres. The percentage of couples who did not accept
any method of fertility control ranged from 15.1 to 69.0 at the study centres (Fig 17).
DISCUSSION
Strategies for service deliveryxmust vary in different countries as well as in different
regions within the same countryt To provide maximal benefits, local priority needs
must be identified and services geared to first meet the needs of those who are at
high . risk. The priority accorded to each element of maternity care and the strategy
for its delivery within primary health care, should be based on assessed local needs,
socio-cultural characteristics of the population and available resources. Priorities
should be determined in the light of criteria such as the magnitude and severity, as
well as the health and social consequences of the problem; feasibility, cost and
effectiveness of the health action; and demands for care and acceptance of services
by the community.
161
MCM as a Managerial Tool
While there is an urgent need in developing countries to clearly define priorities
for action in order to ensure the rational and optimal utilisation of limited resources,
there is, unfortunately a paucity of reliable health and service statistics in these
countries which makes it difficult to evaluate services for defining local priorities.
MCM aims to bridge this gap by utilising the action-oriented or applied research
approach for the collection of accurate local data on sociodemographic and clinical
variables at all service levels and also provides a simple and reliable tool for
evaluating these data and monitoring programme impact. A broad range of factors
governing high risk groups, management and outcome of delivery as well as intervention
to improve outcome can be evaluated and epidemiological comparisons can be made
between the biological and socio-environmental factors which operate interactively
to influence pregnancy outcome. Thus, MCM provides a managerial tool for the assess
ment of alternative approaches and priorities in the delivery of maternity services
and, thereby, enables appropriate allocation and reallocation of resources for
improved population coverage and effective implementation of integrated maternity
and family planning services.
MCM as a Tool for Service Providers and Programme Planners
The present analysis focuses on inter-centre comparisons of key indices with the
objective of evolving a simple to apply, and easy to use methodology for ranking
the performance of different maternity centres by commonly defined indices. This
analysis highlights characteristics^ such as age, parity and education, of women
delivering at these centres. Positive health indices such as birth weight, and
negative health indicators such as the morbidity and mortality rates are also described.
It also depicts trends and associations between patient characteristics, maternity
services and pregnancy outcome. The findings are displayed on an abacus in a ranked
manner sd that the results can be easily interpreted and utilised by service providers
for defining priorities. A national abacus, may similarly be used by programme
planners for reviewing programme performance at the national level. A regional abacus
wduld provide a comparison of programme performance between different geographical
regions of the country. This method can thus be used by programme planners at the
regional and national levels for developing programme strategy. It can also be used
at the local level for programme implementation. Thus MCM provides a tool to enable
programme planning and implementation based on reliable local data. The present
analysis serves as an example to illustrate this. This analysis not only describes
the type of women delivered at the study centres, her obstetric background and her
morbidity and mortality experience, but highlights the causes of maternal and perinatal
mortality at these centres and demonstrates the multiple interactions between the
various causative factors. Such feedback especially when available on a periodic basis,
can be effectively utilised for identifying priority problems, implementing
appropriate health measures to combat them and evaluating such measures.
The present analysis shows that the sociodemographic characteristics of the women
delivering at the study centres were similar. These women were generally young,
of low parity and varying educational background. Several different clinical patterns
were seen. While there were wide morbidity and mortality differentials between centres,
the morbidity and mortality patterns were consistent within centres. This indicates
that certain aetiological factors were operational within certain institutions causing
162
high complication rates in the antenatal, intranatal, postnatal and neonatal periods
and resulting in high maternal and perinatal losses. By examining the data, some
causative linkages were established. Parity, anaemia, morbidity experience, gestational
age and birth weight were identified as the key factors influencing pregnancy outcome.
Centres with infants of lower mean birth weight showed higher perinatal losses. In
turn, standards of birth weight at various centres were determined by several factors.
Thus, mean birth weight was lower for infants born to anaemic women than for those
born to non-anaemic women, indicating the need for implementing antenatal care programmes
that emphasize the prevention and treatment of anaemia at these centres. Primiparous
women clearly constituted a high risk group. Intranatal complications were consistently
higher, and mean birth weight was consistently lower for primiparous women than for
multiparous women at all centres. The fact that more than a third of the women delivering
at these centres were primiparous, further emphasized the need for special services
for this group. Another high risk group identified through this analysis were women
exposed to the risk of unwanted pregnancy. The need for emphasizing postpartum contra
ceptive programmes at centres with a high proportion of non-acceptors and especially
at centres with a high proportion of women who have completed their desired family
size but do not accept any method of fertility control,was highlighted.
MCM at Various Levels of Maternity Care
For MCM to be effectively utilised, it should be incorporated within the framework
of existing maternity health care services of the country. Standard record systems,
that can be practically utilised by personnel at various service levels, should be
implemented. These record systems must, neccessarily vary in complexity depending on
the category of personnel for whom they are meant. The type of feedback provided
through this system must also be specifically designed for the user so that personnel
at different service levels can effectively interpret data and translate results into
appropriate and effective health measures.
A sophisticated, computerized system may be considered for teaching institutions to
enable investigators to conduct scientific, indepth studies on various aspects of
maternity care and seek answers to the many unknowns in maternal health. While such
studies, undoubtedly, have considerable merit, in developing countries the greatest
need for MCM exists at the peripheral service levels—in district hospitals, and
peripheral health centres (PHCs) where deliveries are conducted primarily by trained
midwives, and even more so, at the traditional birth attendant (TBA) level as the
vast majority of the deliveries in these countries are conducted by TBAs.
The present analysis is based on a system of MCM that is designed for large maternity
institutions. This system has been modified for use at PHCs, where pertinent data
on selected key variables can be obtained by the midwife for monitoring maternity
services at this level. However, since the problems of maternity care in developing
countries relate primarily to service provided by TBAs, high priority should be assigned
for developing simple, cost-effective and practical systems of MCM at this service level.
MCM as a Research Tool
MCM may be used as a research tool to scientifically explore areas of special interest
such as causes of maternal or perinatal morbidity and mortality, epidemiology of low
birth weight (5,6), related aspects of postpartum contraceptive acceptance (7,8),
obstetrical problems (9) and a host of other unknowns in maternity care. Feedback
through this system permits evaluation of health indicators within institutions (10)
163
or group of institutions (11,12) and when such feedback is periodic, the effect
of control measures on these health indices can be measured. In addition to
periodic evaluation within and between institutions, MCM may be used for making
comparisons between maternity care programmes operating in different parts of a
country (8) and also in different countries (2,13).
MCM for Providing Referral Linkages
Within a country, MCM should eventually be operational at all the three service
levels including the large maternity institutions, the peripheral hospitals and PHCs
and also the non-institutional level where deliveries are conducted by TBAs. For
services to be effectively coordinated at these levels, there should be a referral
chain which extends from the periphery (TBAs) to the hospitals via the PHCs. For
the system to be effective, the referral centre, whether a large maternity
institution or a PHC must, provide feedback to the referral source. MCM provides
a linkage for two-way communication between the various service levels and thus,
assists in establishing greatly needed, referral systems. It provides a means for
systematically chanelling data to regional and central levels and feedback to
peripheral levels. While institutional MCM provide important clues to programme
planners for developing service strategy, the regular feedback of data to the
peripheral levels assist service providers in assigning and when needed, reassigning
priorities for programme implementation.
MCM for Staff Supervision and Training
Although basic education and training for health personnel is needed at all service
levels, in-service training and continuing education must receive priority in
maternity care programmes. Regular feedback made available through MCM, can be
effectively utilised as a tool for inservice training of field personnel. Problem
solving and joint evaluation of specific interventions and service coverage, can
be effectively used for imparting training. The added benefit of this approach is
that it can be used locally and does not require staff to stay away from work,
which is a common impediment in implementing training programmes.
CONCLUSIONS AND RECOMMENDATIONS
In developing countries, the overwhelmingly high incidence of maternal and infant
mortality and morbidity are causes of top national concern. Service strategies
for meeting the challenge of minimizing maternal and perinatal losses must be
based on careful evaluation to determine what approaches are most effective in
various settings and what methods are best suited to meet the specific needs of the
high risk groups. In the context of limited resources in developing countries,
priorities must be clearly defined to ensure the appropriate allocation and optimal
utilisation of available resources. This requires that an efficient monitoring system
be built into service programmes so that present needs can be adequately assessed
and future trends anticipated and planned for thorough continuous measurement and
evaluation. Maternity Care Monitoring (MCM) provides a managerial tool for the
assessment of alternative approaches and priorities in the delivery of maternity
services. It assists service providers in determining priorities for action and
programme planners in developing programme strategy, based on reliable local data.
164
To be effectively utilised at the national level, MCM should be incorporated within
the framework of existing service programmes, at all three service levels including
large maternity institutions, peripheral hospitals and health centres, as well as
non-institutional deliveries conducted by TBAs. Hie system utilised for MCM must,
necessarily, vary in complexity depending upon the service level at which it is
implemented so that the feedback through this system can be correctly interpreted
by the user and then effectively translated into appropriate health measures.
Thus, by establishing a standardized system of data collection and analysis and
providing regular and systematic feedback in a meaningful and cost-effective manner,
MCM facilitates improvements in maternity care. Feasible and effective methods of
service delivery, adapted to the socio-cultural and environmental needs, can thus
be implemented to extend health coverage to the vulnerable groups of the population
through the optimal utilisation of local resources.
National health programmes may utilise consultant services offered by the International
Federation for Family Health (Federation) to design and implement systems for MCM
relevant to meet their specific needs. The Federation will assist in developing
Country Projects for implementing MCM which may be eligible for financial support
from the United Nations Fund for Population Activities (UNFPA) and other donor agencies.
ACKNOWLEDGMENT
The authors gratefully acknowledge the following contributors to the India Fertility
Research Programme who have carefully recorded the data from which this paper is
drawn: Drs. S.K. Banerjee, R.V. Bhatt, C.L. Jhaveri, M. Kochhar, A.C. Mehta,
S.P. Mehtaji, V.N.Purandare, D. Patel and Padma Rao.
References
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1977.
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monitoring: A beginning. In: Clinical Perinatalogy3 2nd ed.; A. Aladgem, A.K. Brown
and C. Surean (eds). St. Louis; C.V. Mosbu & Co., v 521-559; 1980.
3. Bernard^ R.P^ Kendall; E.M. and Manton; K.G» International maternity care
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Int. J. Gynecol Obstet 17: 24-39; 1979.
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and predictors of low birth weight.
The incidence; complications
Int. J. Gynecol Obstet 16: 24-27; 1978.
165
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11. Basu3 S. Maternity care in India: An analysis of maternity cases in ten selected
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12. Rao, P. and Pachauri, S. Maternity profile - A comparison between a teaching
hospital and a non-teaching hospital in the same area. Fifth Transaction of
Scientific Papers, India Fertility Research Programme, p 118-121, 1978.
13. Bernard, R.P. International maternity care monitoring: Postpartum family size
expectation and contraceptive behaviour/service in Asia. Presented at IPAVS
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166
FERTILITY CONTROL PRACTICES AMONG 15,221 WOMEN UNDERGOING
HOSPITAL DELIVERY
Saroj Pachauri3 MDy DPH, PhD1
.
2
Armin Jamshed.ji^ MA
ABSTRACT
Data on 15,221 women delivering 15,424 babies at hospitals participating in the Maternity
Care Monitoring Programme of the India Fertility Research Programme (India FRP) are
reported. The majority of the cases were young, married,' low parity women with varying
levels of education. About sixty percent were urban residents. The mean age of the
youngest living child for the series was 3.2 years. Reported rates for induced and
spontaneous abortions and stillbirths were 7.2, 69.4 and 24.0 per 1000 pregnancies.
The Bean number of children desired was 3.4. Desired family size as related to age
and number of living children is discussed, The maternal and perinatal mortality rates
were 1.3 and 47.9 per 1000 deliveries.
While 88.8 percent of the couples had not used any method of fertility control prior to
the present delivery, only 34.8 percent did not agree to accept any fertility control
method after delivery. Female sterilisation (17.3%), oral contraceptives (15.7%) and
condoms (14.1%) were the most popular methods; IUDs were accepted by 10.2 percent cases.
Acceptance of fertility control methods correlated positively with age and number of
living children and inversely with desire for additional children. While oral (18.8%)
and conventional (17.4%) contraceptives were the methods of choice among the younger
couples (wife’s age <19 years), sterilisation (43.8%) was the method of choice among
the older couples (wife’s age 30+ years), Most (62.0%) of couples with four or more
living children selected sterilisation, /Postpartum fertility control acceptance in
relation to age, living children and desired family size is discussed.
INTRODUCTION
In recent years in India as in other countries facing population pressures, there has
been an emphasis on organizing postpartum programmes for hospitals. It is hypothesized
that the postpartum period presents a unique opportunity to provide family planning
services since it brings the potential client in contact with health personnel who can
provide her with an appropriate method for spacing or limiting family’size -at -a time
when she is more likely to be motivated to accept fertility control methods. This
report discusses the sociodemographic characteristics, reproductive history and postpartum
fertility control acceptance among women undergoing delivery*.
MATERIALS AND METHODS
This is a pooled analysis of data on 15,221 women delivering 15,424 babies at selected
hospitals in India during the period January 1976 to January 1978. Data on all cases were
recorded on the single-page maternity record of the India FRP. At these institutions,
maternity services are being concurrently monitored by the Maternity Care Monitorings
system of the India FRP. This system is designed for concurrent computerized monitoring
and evaluation and ensures rapid feedback of results to enable hospital administrators to
suitably modify policies for the management of programmes for maternity care and oostDatrum
postpartum fertility control,
^■Research Director, o Research Assistant, India Fertility Research Programme, Hyderabad.
*Paper published in the Indian Journal of Preventive and Social Medicine, Vol. 10, 63-68,
June 1979.
167
Fertility control acceptance as discussed in this study, includes contraceptive
methods planned and provided and, therefore, except in the case of women undergoing
concurrent sterilisation or IUD insertion there is no evidence that the planned
method was infact used.
Standard definitions were used for all rates and events reported, Neonatal and
perinatal mortality rates reported in this study include stillbirths and infant
deaths prior to discharge from the hospital.
RESULTS
Sociodemographic Characteristics
The study group comprised predominantly of young (mean age 25.9 yeace), low parity
(mean parity 1.5) women with varying levels of education (mean number of school years
6.2). In this series, 26.5 percent of the women were primiparas (Table I). There wasa sharp increase in mean parity with increasing age (Fig 1). While 62.2 percent of
the women were from urban areas, 33.9 percent,, were from rural areas and 3.7 percent were
from slum areas (Table I).
5.0
•H
2.5
—
CTJ
PM
C
(U
E
0
I
I
-I
< 19
20 - 29
30 +
Maternal Age (Years)
Fig 1
MEAN PARITY BY MATERNAL AGE FOR 15,221 WOMEN
UNDERGOING HOSPITAL DELIVERY IN INDIA,
JANUARY 1976 TO 1978
168
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 15,221 WOMEN UNDERGOING HOSPITAL
DELIVERY IN INDIA, JANUARY 1976 TO 1978
Charac teris tics
Number
Percent
133
851
5944
5107
2210
838
121
17
0.9
5.6
39.1
33.6
14.5
5.5
0.8
0.1
Age (Years)
< 17
18 - 19
20 - 24
25 - 29
30 - 34
35 - 39
40 +
Unknown
Mean
25.9
Parity
0
1
2
3
4
5+
Unknown
Mean
34.3
26.5
18.2
10.4
5.4
5.0
0.3
5215
4027
2768
1589
815
767
40
1.5
Living Children
0
1
2
3
4
5+
Wteown
Mean
Sex Ratio
36.0
26.4
17.4
9.2
4.4
3.7
2.9
5481
4015
2647
1404
669
565
440
1.3
99.7*
Age of Youngest Child
< 1
1
2
3
4
5+
No children
Unknown
Mean
2.0
6.0
23.0
13.4
5.9
6.2
31.8
11.7
312
910
3509
2033
899
942
4840
1776
*Sex Ratio = Number of males per 100 females.
3.2
169
TABLE I (CONTD)
Characteris tics
Numb er
Percent
1527
302
769
986
972
812
783
530
8540
10.0
2.0
5.0
6.5
6.4
5.3
5.1
3.5
56.1
Patient’s Education
(School Years)
0
1 - 2
3 - 4
5 - 6
7 - 8
9 - 10
11 - 12
13 +
Unknown
Mean
6.2
Marital Status
Never married
Currently married
Formerly martied/other
Unknown
56
14640
498
27
0.4
96.2
3.3
0.2
9472
5161
560
28
62.2
33.9
3.7
0.2
Residence
Urban
Rural
Slum
Unknown
Reproductive History
The mean age of the youngest child was 3.2 years; it was 2 years in about a fourth
of the cases and 4+ years in 12.1 percent cases (Table I).
The live birth rate was 899.4 per 1000 pregnancies. Reported rates for induced and
spontaneous abortion were 7.2 and 69.4 per 1000 pregnancies respectively, The
stillbirth rate was 24.0 per 1000 pregnancies (Table II).
Desired Family Size
The desired family size was 3.4 children, For women below 20 years of age it
was 2.9 children; for those at 20 - 29 years and above 30 years it was 3.3 and
5.0 children respectively (Fig 2). As the number of living children increased from
one to four. the desire for additional children declined sharply—Figure 3 shows a
170
TABLE II
PREVIOUS REPRODUCTIVE HISTORY OF 15,221 WOMEN UNDERGOING HOSPITAL DELIVERY
IN INDIA, JANAURY 1976 TO 1978
Reproductive History
N umber of Events
Rate/1000 Pregnancies
----------- -—i_______________
Induced abortion
Spontaneous abortion
Stillbirth
Live birth
Unknown
205
1963
678
25436
55
7.2
69.4
24.0
899.4
0.8
a steeply rising curve which plateaus off after four living children, While 32.1
percent of the women with one living child wanted one more child, 64.7 percent of
these women wanted two or more additional
-- children.
------- - About sixty percent of the
women with two living children wanted another child
----- and
--- 15.8
--- 1 percent wanted two
or more additional children. While 39.2 percent of the women with three living
children wanted another child, 16.9 percent with four living children desired one
more child (Fig 3),
6.0
5.0
n?
•s
0)
p
<D
N
3.3
3.0
cn
2.9
$$$
§
Pa
C
oJ
0)
S
0
<19
20-29
30+
Maternal Age (Years)
Fig 2
MEAN TOTAL DESIRED FAMILY SIZE BY MATERNAL AGE
FOR 15,221 WOMEN UNDERGOING HOSPITAL DELIVERY
IN INDIA, JANUARY 1976 TO 1978
171
No Additional Children Desired
One Additional Child Desired
Tw° or More Additional Children Desired
100
w
(D
CD
05
o
50
a(D
O
i-i
a)
p-l
0
1
2
3
4
5
6
7
8
9
10+
Number of Living Children
Fig 3
NUMBER OF LIVING CHILDREN BY ADDITIONAL CHILDREN DESIRED
FOR 15,221 WOMEN UNDERGOING HOSPITAL DELIVERY IN INDIA,
JANUARY 1976 TO 1978
Mortality Rates
There were 20 maternal deaths in this series; the maternal mortality rate was
1.3 per 1000 deliveries. The stillbirth and neonatal mortality rates were 30.5
and 21.1 per 1000 deliveries respectively. The perinatal mortality rate for the
series was 47.9 per 1000 deliveries (Table III).
172
TABLE III
MORTALITY RATES FOR 15,221 WOMEN UNDERGOING HOSPITAL DELIVERY IN INDIA,
JANUARY 1976 TO 1978
Mortality
Maternal mortality
Stillbirths
Neonatal mortality*
Perinatal mortality
Number
Rate/1000 Deliveries
20
470
315
739
1.3
30.5
21.1
47.9
^Deaths before discharge to infants born alive.
Acceptance of Fertility Control Methods
While 88.8 percent of the couples had not used any method of fertility control prior to
the present delivery, only 34.8 percent did not agree to accept any fertility control
method after delivery.. /"
After delivery, there was an increase in the acceptance of all
methods of fertility control except conventional contraceptives.. Female sterilisation
(17.3Z), oral contraceptives (15.7%) and condoms (14.1%) were the most popular methods;
IUDs were accepted by 10.2 percent cases (Fig 4).
Before This Delivery
0.0
Other
] 2.8
2.0
)ther Conventionals
1.5
5.3
I
14.1
Condom
0.0
Vasec tomy
0.0
Tub ectomy
17.3
2.6 [
Orals
3] 15.7
,
IUD
□
0.7
88.8 [
After This Delivery
None
I31
10.2
34.8
Fig 4
CONTRACEPTIVE ACCEPTANCE BEFORE AND AFTER DELIVERY FOR 15,221 WOMEN
UNDERGOING HOSPITAL DELIVERY IN INDIA, JANUARY 1976 TO 1978
173
IUDs
Orals
Sterilisation
C onventionals
Other
■■■■■IB ■■I
16%
24%
4%
_________________________ |
31%
24%
0
50
100
Percent Cases
Fig 5
POSTPARTUM FERTILITY CONTROL ACCEPTANCE BY METHOD FOR 15,221 WOMEN UNDERGOING
HOSPITAL DELIVERY IN INDIA, JANUARY 1976 TO 1978
Figure 5 shows that among couples accepting fertility control, about a fourth selected
oral and conventional contraceptives and 31.5 and 15.8 percent respectively selected
sterilisation and IUDs. Among couples accepting sterilisation, the.majority desired
female sterilisation (84.7%); 81.5 percent of the women accepting sterilisation underwent
concurrent sterilisation. Among the conventional contraceptive acceptors, the vast
majority (90.6%) accepted the condom.
Postpartum Fertility Control Acceptance by Age, Living Children and Additional Children
Desired
Acceptance of fertility control methods correlated positively with age (Table IV and
Fig 6) and number of living children (Table V and Fig 7) and inversely with desire for
additional children (Table VI and Fig 8).
TABLE IV
PREVALENCE OF FERTILITY CONTROL METHODS BY MATERNAL AGE FOR 15,221 WOMEN UNDERGOING
HOSPITAL DELIVERY IN INDIA, JANUARY 1976 TO 1978
Maternal Age (Years)
20 - 29
30 +
N=11016
N=3162
Fertility Control
Method
<19
N=982
IUD
Orals
Sterilisation
Conventionals
Other
10.6
18.8
1.4
17.4
4.1
11.2
17.5
15.5
17.3
2.9
7.3
8.8
43.8
9.3
2.2
TOTAL
52.3
64.4
71.4
174
c
CD
d
•cd
I
o
•rl
CD
g
I—I
<19
S M
3ccJ
CD
O
cn
u o
s
at Suf
> <D
C rC
O 4J
CD
G
o
N=982
CD
d
CD
P*
20-29
N=11016
bO
s
0)
4J
30+
N=3162
tsusss >1
JS
0
■■■■■■■J. ■■
50.0
Percent
■
100.0
Cases
Fig 6
a
PREVALENCE OF FERTILITY CONTROL METHODS BY MATERNAL
AGE FOR 15,221 WOMEN UNDERGOING HOSPITAL DELIVERY
IN INDIA, JANUARY 1976 TO 1978
While oral (18.8%) and conventional (17.4%) contraceptives were the methods of
choice among the younger couples (wife’s age <19 years), sterilisation (43.8%) was
the method choice among the older couples (wife’s age 30+. years). At 20 to 29 years
of age, oral (17.5%) and conventional (17.3%) contraceptives and IUDs (11.2%) were
the most prevalent methods (Table IV and Fig 6).
TABLE V
PREVALENCE OF FERTILITY CONTROL METHODS BY NUMBER OF LIVING CHILDREN FOR 15,221
WOMEN UNDERGOING HOSPITAL DELIVERY IN INDIA, JANUARY 1976 TO 1978
Number of Living Children
Fertility Control
< 3
N=11802
4+
1N=2589
IUD
Orals
Sterilisation
Conventionals
Other
11.7
18.0
11.9
18.3
3.1
4.3
7.2
62.0
4.6
2.0
TOTAL
63.0
80.1
Me thod
175
When the number of living children was three or less the prevalence of oral
contraceptives was about 18 percent in each case and that of IUDs and sterilisation
was about 12 percent in each case. Most (62.0%) of couples with four or more living
children selected sterilisation (Table V and Fig 7). Sterilisation (63.7%) was the
method of choice among couples who did not desire additional children, However, 12.0
percent of these couples did not accept any method of fertility control, Acceptance
rates for methods were similar among couples desiring one or two additional children
(Table VI and Fig 8).
w
c
o
C
o
d .
•rl
H
c
W
<D
§
nJ
l-l
C
w
d
o
0J
<D
>
a
cn
o
o
4J
0)
X
4J
■
o
0)
C
o
I
x:
o<3
60
a
N=11802
>
•H
U-l
O
1^
4+
N=2589
<D
1
0
1
I
50.0
Percent Cases
Fig 7
100.0
PREVALENCE OF FERTILITY CONTROL METHODS BY NUMBER OF LIVING
CHILDREN FOR 15,221 WOMEN UNDERGOING HOSPITAL DELIVERY
IN INDIA, JANUARY 1976 TO 1978
TABLE VI
PREVALENCE OF FERTILITY CONTROL METHODS BY NUMBER OF ADDITIONAL CHILDREN
DESIRED FOR 15,221 WOMEN UNDERGOING HOSPITAL DELIVERY IN INDIA,
JANUARY 1976 TO 1978
Additional Children Desired
1
2+
N=5627
N=4493
Fertility Control
Me thod
0
N=4779
IUD
Orals
S terilisation
Conventionals
Other
7.6
7.9
63.7
6.5
2.3
22.3
0.7
22.3
2.7
13.9
25.2
0.7
27.9
6.8
TOTAL
88.0
61.7
74.5
13.7
176
I
C
CD
•H
05
o
C
o
nJ
CD
w
g
TJ
(D
0
%
1
7/
•rl
c0)
w
nJ
O
>
(1)
(D
C
a x:
-P O
oo o
z
(U
U
cn
N=4779
•H
CD
<D
Q
C
(D
ki
.
N=5627
•H
XI
O
nJ
CJ
o
kxxxl
2+
| N=4493
•H
•H
<5
1
0
50.0
Percent
100.0
Cases
Fig 8
PREVALENCE OF FERTILITY CONTROL METHODS BY ADDITIONAL
CHILDREN DESIRED FOR 1'5,221 WOMEN UNDERGOING HOSPITAL
DELIVERY IN INDIA, JANUARY 1976 TO 1978
DISCUSSION
Studies show that there is «an increase
*
' acceptance of fertility control methods
in the
after menstrual regulation (1,2) abortion (3,4) and delivery (5,6).. fSeveral Ii0<p<ttals
organize programmes for providing contraceptive information
and servicesj to women in
the postabortion and postdelivery period on the assumption that women are likely to
be receptive to methods for limiting family size or spacing future children.
In this analysis, the authors have attempted to isolate factors which determine fertility
control acceptance for women undergoing hospital delivery in India. The results of
this analysis indicate that in this group of relatively young, low parity women
representing both urban and rural areas, there was a marked increase in fertility
control acceptance. Six out of every ten women chose a method after delivery even
though nine out of ten had not used any method of fertility control before delivery.
However, a little over a third of this group did not agree to accept any method of
fertility control. These were predominantly the younger, low parity women desiring
additional children. Contraceptive counselling programmes should aim to motivate these
women to accept spacing methods. Oral contraceptives and condoms were the methods of
177
choice among couples who wished to space their future children and female sterilisation
was the method of choice among those who had completed their desired family size.
While one out of every six couples who had completed their families selected
sterilisation for control of fertility, there remained a hard chore of 12 percent,
couples who did not agree to accept any method even though they had completed their
desired family size. More intensive contraceptive counselling is needed for this
group of cases.
o__- women desire smaller families and that the
This analysis indicates that younger
desired
number of additional children C------- is inversely related to the number of living^
■ the
’ sex■ of the living children is not examined. While
children. The association with
mortality experience of the study population are provided in this report,
data on the
1
attempt
has
been made to evaluate the effect of previous pregnancy outcome on the
no
decision to use contraceptive methods. In a subsequent analysis, the authors propose
to test the hypothesis that women experiencing
more favourable pregnancy outcome are
( „
children
and
accept
fertility control methods.
more likely to desire fewer
ACMOWLEDGMENT
The authors gratefully acknowledge the contributors to the India Fertility Research
Programme who have carefully recorded the data from which this paper is drawn.
References
1. Pachauri, S. and Fortney, J. Menstrual regulation - An international oyervzew.
Proceedings of second International Seminar on Maternal and Perznatal Mortality,
Pregnancy Termination and Sterilization, Bombay, India, p 512-537, 1975.
2. Mullick, B., Dawn, C.S., Pachauri, S., Bernard, R.P. and Kessel, E, Menstrual
requlation - A community service in Howrah District, India. Presented at e
Conference on Menstrual Regulation, University of Hawaiv, USA, December 18, 19
.
3. Margolis, A., Rindfuss, R., Coghlan, P. and Ro chat, R^ Contraceptron after Abortion.
1974^ 56-60.,
Family Planning Perspective, Vol. 6, No. 1, Winter
1’4. Hogue. C.J., Kleinbawn, D.G., Omran, A.B., Gruber, F.J. and Freeman, D.H. Idle zmpaet
of personal characteristics on postabortion contraceptive acceptance. 102nd Annual
Meeting of the American Public Health Association, New Orleans, Louisiana, October
20-24, 1974.
* India.
" • CovernmeYit of India, Ministry of
5. Year Book. Family Welfare Programme in
Health & Family Welfare, Department of Family Welfare, New Delhi, 1975-76.
study of the delivery ratio and postpartum
6. Sadashiviahy K. A
A retrospective
i
sterilisation in Mission hospitals in India., The Journal of Family Welfare,
Vol. XXII, No. 3, March 1976.
178
PRETEST OF THE MATERNITY CARE MONITORING CORE QUESTIONNAIRE FOR
PERIPHERAL HEALTH CENTRES
P.V. Bhatt, MD, DCH1
Saroj Pachauri^ MD^ DPH, PhD^
ABSTRACT
This is a report of a pretest of the Core Questionnaire recommended for Maternity
Care Monitoring (MCM) at peripheral health centres. Data on 100 maternity cases
attending the Padra Primary Health Centre in Baroda District were recorded by
medical interns. High maternal morbidity and perinatal mortality rates and low birth
weight are reported. Recommendations are made to improve the record. It should'be
pretested by midwives on a larger series of cases.
INTRODUCTION
The major goal of Maternity Care Monitoring (MCM) is to assist in establishing a
standardized system of data collection and analysis which provides systematic feedback
of programme performance and highlights priorities for action at various levels of
maternity care provided through hospitals, peripheral health centres and traditional
birth attendants (TBAs). In response to the need expressed by several developing
countries, a standardized system for monitoring maternity care at hospitals, was
conjointly developed and pretested by the International Fertility Research Program
(IFRP) and the International Federation of Gynaecology and Obstetrics (FIGO).
While there are obvious advantages in using internationally standardized record
systems, it is nevertheless, most important to ensure that they are designed to meet
specific local needs. The International Federation for Family Health (Federation) is
presently assisting its member countries to consititute national Task Forces
for MCM. The Task Force for each country will review the experience of local
investigators with the international record systems and modify them for Ideal
use. While this will ensure adherence to standard definitions and comparability
across countries, it will also make it possible to specifically adapt the system for
the needs of each country.
The record system for MCM at hospitals is standardized and computerized and has been
extensively pretested (1-5). There is, however, an urgent need to develop and pretest
record systems for the peripheral health centre'-and TBA levels of maternity care
as in developing countries the vast majority of the deliveries
---- --- ; are not conducted in
hospitals.
After carefully reviewing the internationally standardized hospital record
record system,
system.
members of the^Federation, FIGO, and national Task Forces from several countries
recommended a Core Questionnaire for peripheral health centres (Page 179) . This record
will be pretested by member countries of the Federation, This is a report of a pretest
of the Core Questionnaire which was conducted in Baroda, India.
iprofessor and Head, Department of Obstetrics and Gynaecology, Baroda Medical College,
Baroda.
^Project Director, International Maternity Care Monitoring Project, Hyderabad.
179
MATERNITY CARE MONITORING RECORD
Please circle appropriate choices and fill in boxes and blanks.
PATIENT IDENTIFICATION:
2. Admission date
1. Maternity service
day
Husband's Name ------
3. Patient's name
year
month
4. Address
STUDY IDENTIFICATION
5. Center name---------------
THE NEWBORN
22. Birthweight in grams.
(888 if referred before delivery)
and number.
8 0
6. Study number:
1
7-11
7. Patient order number:
ia-v
8. Delivery date:
day
month
year
PATIENT CHARACTERISTICS
9. Patient's age: (completed years)
ai-aa
10. Patient's education: (school year completed) 0) 0
1)1-2 2)3-4 3)5-6 4)7-8 5)9-10 6)11-12
7) 13-14 8) 15+
as
|
11. Patient's height in cm:
PAST OBSTETRIC HISTORY
12. Total live births:
13. Children now living:
number of males
(8 or more = 8)
number of females
14. Number of stillbirths: (8 or more « 8)
15. Number of infant deaths: (less than 12 completed
months; 8 or more
8)
16. Outcome of last pregnancy. 0) not previously pregnant
1) live birth, full term, still living 2) live birth, full term,
deceased 3) live birth, premature, still living 4) live
birth, premature, deceased 5) stillbirth 6) induced
abortion 7) spontaneous abortion 8) other
ar>aa
at
sa
I
I*3
|
|M
25. Status of fetus/newborn: 0) living 1) died before
admission 3) died after admission-ante/intrapartum
|
5) died postpartum 8) other |
••
|
24. Primary fetal/neonatal condition: 0) normal, or stillbirth
with no apparent pathology 1) fetal distress during
labor 2) malformation 4) respiratory distress
syndrome 7) trauma 8) other For codes 2), 7). 8).
specify -------- ------------------- -- ------------ ---------------------
THE MOTHER
,
26. Primary puerperal condition: 0) normal 1) fever requiring
treatment 2) bleeding requiring treatment 7) death
j
(complete Death Report) 8) other
|
70
SPECIAL STUDIES
27. Source of referral
73
28. Appropriateness of referral
74
29. Risk assessment score
75
33
3#
37-35
CURRENT PREGNANCY AND DELIVERY
18. Number of antenatal visits: (8 or more - 8)
40
19. Estimated duration of pregnancy: (menstrua! age in
completed weeks)
45-47
21. Attendant at labor/delivery. 0) none 1) nurse 2) qualified
midwife 3) student nurse/midwife 4) auxiliary/TBA
5) medical student 6) general physician 7) OB/GYN
physician 8) other
_ _______
I
|
23. Sex of infant(s) born at this delivery:
number of males
(write number of each)
number of females
30
17. Number of months since last pregnancy ended.
(98 or more = 98}
20. Type of delivery: 0) spontaneous 1) outlet forceps
2) vacuum extractor 5) breech extraction 6) cesarean
section 7) destructive procedure 8) other
1 I M*0-”
FAMILY PLANNING
COMPLETE THESE ITEMS AT TIME OF DISCHARGE
30. Female sterilization: 0) none 1) before this delivery
2) at cesarean section 3) immediately after delivery
4) same day 5) 1-2 days later 6) 3-4 days later
7) 5-9 days later 8) 10 or more days later
31. Number of additional children wanted: (8 or more = 8)
32 Oontrateptive method planned or provided: 0) none
1HUD 2) orals/injectables 3) female sterilization
4) male sterilization 5) condom 6) withdrawal/rhythm
7) foam/diaphragm/jelly 8) other
1 50
Recorder's name
Please mail to
54
MAT601—kki093
55
75
1/80
180
MATERIALS AND METHODS
Data
Data on
on 100 maternity cases attending the Padra Primary Health Centre in Baroda
District, India between November 1979 to January 1980 were recorded by medical
Data
were obtained
interns on the Core Questionnaire. L
-- ---- - ’ on .patient
" characteristics,
obstetrical events, antenatal care, delivery, foetal/neonatal status, puerperal
status, desire for additional children and postpartum fertility control.
Definitions and Criteria
All deliveries conducted at the health centre, regardless of outcome were included.
Induced and spontaneous abortions (with a foetus weighing less than 500 grams and
gestation upto 19 weeks), molar pregnancies and false labours were excluded, The
duration of pregnancy was estimated in completed weeks from the onset of the
last normal menstrual period to the day of the delivery.
For estimating the perinatal mortality rate, stillborn infants weighing 1000 grams
or more and early neonatal deaths of infants were included. Neonatal death was
defined as infant death prior to discharge from the health centre.
RESULTS
Sociodemographic Characteristics
The average woman delivering at this centre, was 27.7 years of age, 156.4 centimetres
tall and had 1.4 years of school education. Ten percent of the women were below
19 years, 60.0 percent were between 20 to 29 years and 30.0 percent: were above 30
38.0 percent were
years of age. The majority (74.0%) were 150—159 cms tall. While
I—
illiterate, 50.0 percent had 1 to 2 years of formal education (Table I).
Obstetric History
While 15.0 percent of the women were nulliparous, 30.0 percent had 1 to 2’.live
births and 55.0 percent had 3+ live births. Mean parity was 2.9; 53.0 percent had
2 to 3 living children, 20.0 percent had 4 or more living children and 17.0 percent
" '. The sex ratio for the study group was 122.8. Stillbirths
had2 no 11
living child.
and child loss were experienced by 18.0 and 20.0 percent of the women respectively
(Table II).
Outoome of Previous Pregnancy
The last pregnancy ended in a live birth, stmoircn
.„, 7.0 and 13.0
stillbirth ana
and suuilwu
abortion in —
68.0,
percent of the cases respectively
respectively.. Among the livebirths, 46.0 percent were fullterm
deliveries and 22.0 percent were premature deliveries. Twelve percent of the women
had not experience a prior pregnancy (Table III).
181
TABLE I
SELECTED PATIENT CHARACTERISTICS OF 100 WOMEN ATTENDING THE PADRA PRIMARY
HEALTH CENTRE IN BARODA DISTRICT, BARODA, NOVEMBER 1979 TO JANUARY 1980
Patient Characteristics
Percent Cases
Age (Completed years)
< 17
18 - 19
20 - 24
25 -r 29
30 - 34
35 +
Mean
6.0
4.0
34.0
26.0
27.0
3.0
27.7
Education (School years)
0
38.0
50.0
11.0
1.0
1.4
1 - 2
3-4
5-6
Mean
Height (Cms)
< 149
150 - 155
156 - 159
160 +
Mean
5.0
31.0
43.0
21.0
156.4
50
49.0
ZZZ/
a
e
£
29.0
ZZZz
ZZZ/
zzzz
25
•M
✓ z/z.
zzzz,
zzzz.
zzzz.
zzzz.
zzzz,
■zzzz.
zzzz.
zzzz.
c
a)
o
o
zzzz.
22.0
ZZZZ,
0
0
>
'^7//
V///.
7///'
•7/7/.
///,,
1
3
4-7
Number of Antenatal Visits
Fig 1
NUMBER OP ANTENATAL VISITS REPORTED FOR 100 WOMEN ATTFNDTNC m
PADRA PRIMARY HEALTH CENTRE IN BARODA DISTRICT, BARODA^NOVEMBER
1979 TO JANUARY 1980
182
TABLE II
OBSTETRIC HISTORY OF 100 WOMEN ATTENDING THE PADRA PRIMARY HEALTH
CENTRE IN BARODA DISTRICT, BARODA, NOVEMBER 1979 TO JANUARY 1980
Obstetric History
Percent Cases
Parity
0
1-2
3-4
5 +
Mean
15.0
30.0
47.0
8.0
2.9
Number of Living Children
0
1
2
3
4 +
Mean
17.0
10.0
27.0
26.0
20.0
2.7
Sex ratio >
122.8*
Stillbirth
0
1
2
82.0
16.0
2.0
Child loss
0
1
2
80.0
19.0
1.0
^Number of males per 100 females.
TABLE III
OUTCOME OF PREVIOUS PREGNANCY FOR 100 WOMEN ATTENDING THE PADRA
PRIMARY HEALTH CENTRE IN BARODA DISTRICT, BARODA, NOVEMBER 1979
TO JANUARY 1980
Outcome
Never pregnant
Full-term live birth still living
Premature live birth still living
Premature live birth deceased
Stillbirth
Induced abortion
Spontaneous abortion
Percent Cases
12.0
46.0
12.0
10.0
7.0
1.0
12.0
183
Antenatal Care
Twenty two percent of the women in the study group received no antenatal care;
49.0 percent had 1 to 3 antenatal visits and 29.0 percent had 4 to 7 antenatal visits
(Fig 1).
Labour and Delivery
Mean duration of pregnancy was 39.3 weeks. Delivery was spontaneous in 90.4 percent
cases. Breech extractors and forceps were used in 5.3 and 4.2 percent cases
respectively (Table IV). There were no multiple deliveries. In this series, 56.4
percent of the deliveries were conducted by a nurse and 12.8 percent by a midwife.
Student nurses and midwives conducted 21.3 percent and only 3.2 percent cases were
delivered by a general physician, No assistance was available during pregnancy
in 5.3 percent cases (Table IV).
TABLE IV
ATTENDANT AT DELIVERY AND TYPE OF DELIVERY FOR 94 WOMEN DELIVERED AT THE PADRA
PRIMARY HEALTH CENTRE IN BARODA DISTRICT, BARODA, NOVEMBER 1979 TO JANUARY
1980
Attendant at
Delivery
Type of Delivery
Spontaneous
Outlet Forceps
No.
%
No.
7O
Breech Extractor
No.
%
Total
No.
%
52
61.2
0
0.0
1
20.0
53
56.4
Student nurse/
midwife
18
21.2
0
0.0
2
40.0
20
21.3
Qualified midwife
10
11.8
0
0.0
2
40.0
12
12.8
Medical student
0
0.0
1
25.0
0
0.0
1
1.1
General physician
0
0.0
3
75.0
0
0.0
3
3.2
None
5
5.9
0
0.0
0
0.0
5
5.3
85
100.0
4
100.0
5
100.0
94
100.0
Nurse
TOTAL
Note: As six cases were referred to a hospital, data on 94 cases are reported in
this and all subsequent tables.
Birth Weight
The male-female sex ratio was 224.1. Mean birth weight of the infants in this series
was 2379.5 grams. Mean birth weight of male infants (2580.3 gms) was significantly
higher than that of female infants (2421.9 gms). However, the percentage of low birth
weight (< 2500 gm) was not significantly higher among female infants (55.2%) than
among male infants (35.3%) (Fig 2).
184
Male
60
Female
30
29.2
56.9
w
(D
CO
O
C
0)
u
CD
Ph
13.8
6.1F5SI
0
<1999
2499
2999
3000
Birth Weight
Fig 2
BIRTH WEIGHT BY SEX OF 94 INFANTS DELIVERED AT THE PADRA
PRIMARY HEALTH CENTRE IN BARODA DISTRICT, BARODA,
NOVEMBER 1979 TO JANUARY 1980
Complications and Referrals
Postpartum complications were reported for 16 (17.0%) women. Fever requiring treatment
(11.7%) was the most commonly reported puerperal complication. Urinary tract
woman developed mastitis and another
infection was reported for 3 (3.2%) cases. One
(
developed phelebitis (Table V). Six women were referred to the district or to the
general hospital. The
reasons for referral were placenta previa, cord prolapse,
r.-- ------ecclampsia, antepartum haemorrhage and shoulder presentation with hand prolapse.
Perinatal Mortality
There were no maternal deaths but high perinatal losses, There were 2 (2.1%) foetal deaths
before admission and 8 (8.5%) after admission. The stillbirth rate was 106.4 per
1000 pregnancies. The neonatal and perinatal death rates were 95.7 and 202.1
per 1000 pregnancies respectively (Table VI).
185
TABLE V
PRIMARY POSTPARTUM COMPLICATIONS REPORTED FOR 94 WOMEN DELIVERED AT THE
PADRA PRIMARY HEALTH CENTRE IN BARODA DISTRICT, BARODA, NOVEMBER 1979
TO JANUARY 1980
Postpartum Complications
Number
Percent
Fever requiring treatment
Urinary tract infection
Mastitis
Phelebitis
11
3
1
1
11.7
3.2
1.1
1.1
16
17.0
TOTAL
TABLE VI
MORTALITY RATES REPORTED FOR 94 WOMEN DELIVERED AT THE PADRA PRIMARY
HEALTH CENTRE IN BARODA DISTRICT, BARODA, NOVEMBER 1979 TO JANUARY
1980
Mortality
Number
Maternal mortality
Stillbirth
Neonatal mortality*
Perinatal mortality**
0
10
9
19
Rate/1000 Deliveries
0.0
106.4
95.7
202.1
^Deaths before discharge to infants born alive
**Neonatal deaths plus stillbirths4
Desire for Additional Children and Postpartum Fertility Control Acceptance
The majority (71.6%) of the women in this study wanted additional children. While
40.0 percent wanted one additional child, 8.4 percent wanted 3 more children
(Table VII).
More than half (57.5%) of the women in the series did not accept any method of
fertility control after delivery. However, 23.4 percent underwent postpartum
sterilisation. Four (4«2^) accepted IUDs and 9.6 and 2.1 percent of the husbands
respectively accepted the condom and sterilisation (Table VII).
TABLE VII
NUMBER OF ADDITIONAL CHILDREN WANTED AND PLANNED CONTRACEPTIVE METHOD FOR 94 WOMEN DELIVERED AT THE PADRA PRIMARY
HEALTH CENTRE IN BARODA DISTRICT, BAORDA, NOVEMBER 1979 TO JANUARY 1980
IUD
None
Number of Additional
Children
Orals
Female
Ster ilisation
No.
7O
Male
Sterilisation
No.
%
Condom
To tai
No.
%
No.
7.7
0
0.0
26
100
0
0.0
5
13.2
38
100
0.0
0
0.0
4
18.2
22
100
0
0.0
0
0.0
0
0.0
8
100
22
23.4
2
2.1
9
9.6
94
100
No.
%
No.
%
No.
%
0
1
3.8
0
0.0
1
3.8
22
84.6
2
1
29
76.3
3
7.9
1
2.6
0
0.0
2
18
81.8
0
0.0
0
0.0
0
3+
7
87.5
1
12.5
0
0.0
TOTAL
55
57.5
4
4.2
2
2.1
00
187
COMMENT
The present pretest of the Core Questionnaire highlighted the following aspects.
. The analysis results showed extremely high stillbirth and neonatal
mortality rates prevailing in this area. The women included in the pretest
reported high pregnancy wastage and foetal loss. The incidence of postpartum
complications reported for this group was considerably higher (17.0%) than
that reported in a pooled analysis of data from several centres (2.5%) in
India (6) and was also higher than that reported (3.1%) from a rural area (7).
Mean birth weight was lower and percentage of low birth weight (< 2500 gms)
infants was higher for this series than for other series (6,7). Thus, high
levels of mortality and morbidity were demonstrated despite the small sample
pretested indicating the immense potential of the Core Questionnaire as a
monitoring tool. However, inorder to scientifically evaluate the quality of
feedback and to finalize the record, a pretest of a larger series is suggested.
. This analysis provided data on the incidence of perinatal mortality which
was found to be very high in this series. However, data on causes of death
were not available. To obtain this important information, the PHC doctor must
complete the Perinatal Mortality Record for all stillbirths and neonatal
deaths and the Death Report for all Maternal deaths.'
. For effective, continued use at the PHC, the Core Questionnaire should be
in the form of a register.
. Training in data recording is : necessary to ensure that data are completely
and accurately recorded by health personnel.
. An instruction manual is needed to facilitate accurate recording of data and to
ensure adherence to standard definitions and uniformity in data recording.
• A suitable referral record with clear instructions is needed for reporting
referrals from the PHC to the district or other hospitals.
. Addition of items ,should be considered for recording data on method of last
delivery, antenatal conditions and complications of labour/delivery.
. As this record is intended to be used by the nurse and midwife, it should
be translated into the local language. In the present pretest, the record
was not translated and data were recorded by the medical intern. It is
recommended that another pretest be conducted after translating the record
to evaluate its practicability when it is used by the nurse and midwife.
188
References
1. Bernard, R.P.,, Kendall, E.M. and Manton, K.G. International maternity care
monitoring: A beginning. Clinical Perinatalogy, Second Edition, S. Aladjem,
A.K. Brown, and C. Bureau, eds. St. Louis: C.V. Mosby & Co., 1980 p 521-559.
2, Bernard, R.P. Introducing maternity care monitoring in Egypt. Presented at the
4th Annual Conference , Egyptian Fertility Control Society, Egypt Fertility
Research Programme Session, Cairo, Egypt, June 25, 1977.
3. Caceres, E.M., Stewart, K.R. and Goldsmith, A. The incidence, complications
and predictors of low birth weight. Int. J. Gynecol. Obstet. 16: 24-27, 1978.
4. Bernard, R.P., Kendall, E.MX, Peng, J.Y. and Kessel, E. Maternity care monitoring
(MCM): Where next? Presented at the IGCC/IFRP East & South East Asia Seminar
on Regional Fertility Research, Bangkok, Thailand, July 18-20, 1979.
5. Basu, S. Maternity care in India: An analysis of maternity cases in ten selected
hospitals. Fifth Transaction of Scientific Papers, India Fertility Research
Programme, p 106-110, 1978.
6. Pachauri, S. and Jamshedji, A. Maternity care monitoring: An illustration from
India. Scientific papers of the India Fertility Research Programme, p 104-122,
1980.
7. Pachauri, S. and Jamshedji, A. Maternity care monitoting: A comparison of nine
centres. Scientific Papers of the India Fertility Research Programme p 138-165,
1980.
189
PREGNANCY TERMINATION WITH THE BATTELLE HAND PUMP - STUDIES IN INDIA
Saroj Pachaurij MD, DPH3 PhD^-
Elizabeth John3 MSc^
ABSTRACT
A hand pump was developed by Battelle in the USA with the objective of providing
equipment for rural areas which is safe, effective and efficient, is easy to use,
repair and maintain, and does not require the use of electrical energy. The results
of studies conducted by the India Fertility Research Programme (India FRP) indicate
that the Battelle Hand Pump can be used safely, effectively and efficiently for
terminating first trimester pregnancies, The design of the hand pump has been
replicated locally and this equipment will be now manufactured in the country soon.
INTRODUCTION
For the successful implementation of rural programmes for termination of pregnancy,
it is necessary to equip rural health centres providing these services with equipment
which not only satisfies the criteria of low cost, safety and effectiveness but is
also easy to use, maintain and repair and most importantly, is such that it does not
require the use of electrical energy, With these criteria in mind, a hand pump was
developed by Battelle in the USA. This is a report of studies conducted by the
India FRP at five centres with the objective of evaluating the safety, effectiveness
and technical efficiency of the Battelle Hand Pump for terminating first trimester
pregnancies.
MATERIALS AND METHODS
Data on 878 pregnancy termination procedures performed with the Battelle Hand Pump
at five centres in India from August 1976 to April 1978 were reported on standard
forms of the India FRP.
Definitions and Criteria
Physically healthy women with pregnancies upto 10 weeks’ gestation were included
in the study. Gestational age was calculated as the number of completed weeks from
the first day of the patient’s last normal menstrual period to the day her pregnancy
was terminated. Technical failure was defined as a case in whom the uterus could
not be successfully evacuated with the hand pump technique and another method had
to be used for completing the abortion. Procedure time was the time from the first
insertion to the last removal of the speculum and cannula time was the time from the
first insertion to the last removal of the cannula. Cannula obstruction was defined
operationally by the number of times it was removed from the uterine cavity. Compli
cations and complaints were categorised into the immediate and follow-up categories.
Immediate complications and complaints were defined as those occurring from the time
the procedure was initiated to the time the patient was discharged, Follow-up
complications and complaints were defined as those occurring between the patient’s
discharge and her follow-up contact 2 to 4 weeks after pregnancy termination. Blood
Research Director, 2 Research Assistant, India Fertility Research Prn?raiwR
Hvdpi-aharl
190
loss during the procedure was estimated by the operator from the aspirated uterine
contents. Blood loss of 100 ml or more was defined as excessive.
The equipment was evaluated using the following criteria:
1. Procedure and cannula time
2. Incidence of technical failures and difficulties.
3. Frequency of cannula obstruction.
4. Incidence of complications and complaints
The recommended period of follow-up was from 2 to 4 weeks after the procedure.
In this study 94.6 percent cases returned for follow-up history and examination.
All statistical tests were performed using a significance level (p value) of 0.05.
The Abortion Procedure
The procedures were performed without anaesthesia at all except one centre where
paracervical block anaesthesia with 10 ml of 1 percent xylocaine was used for
terminating pregnancies of 6 to 10 weeks’ gestation. At one of the centres no
analgesia or anaesthesia was used. At the other three centres, however, analgesia
was used. At one centre premedication in the form of 100 mg of pethidine and 0.6 mg
of atropine was administered intramuscularly half an hour prior to the procedure.
At another, the patient received 5.0 to 7.5 mg of intravenous diazepam and 500 mg
of analgin.
Cold sterilisation was used for sterilising the equipment. The patient was placed
in the dorsal lithotomy position and draped. A pelvic examination was performed
and the vulva was cleansed. A Sim’s speculum was introduced to retract the
posterior vaginal wall and the cervix was grasped with a tenaculum or volsellum.
The uterus was sounded and the length of its cavity was measured to determine the
degree of cervical dilatation and the size of cannula needed. The cervix was then
dilated upto the required size and the appropriate size of cannula was introduced
into the uterus while the hand pump was kept precharged. The cannula was then
connected to the hand-operated vacuum pump assembly. The pinch valve was released,
the cannula was gently rotated through 180° and gradually withdrawn to the middle
of the uterine cavity. Aspiration was considered complete if air bubbles appeared
in the cannula. After aspiration, a check curettage was routinely performed.
Prophylactic antibiotics were routinely administered at 4 centres. The material
collected in the flask was first visually examined and was then sent for histo
pathological examination. A detailed description of the Battelle Hand Pump and
its operating mechanism has been reported in an earlier publication (1).
RESULTS
Sociodemographic Characteristics
The mean age of the women undergoing abortion was 26.8 years. Their mean
parity was 2.2; 12.2 percent had no live births. Their mean education was 9. 0
school years; 57.7 percent had 10 or more years of school education (Table I)
191
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 878 WOMEN UNDERGOING FIRST TRIMESTER ABORTION
WITH THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976 TO APRIL 1978
Numb er
Percent
Age (Years)
< 19
20 - 24
25 - 29
30 - 34
35 +
Mean
42
292
286
169
89
4.8
3 3.3
32.6
19.2
10.1
Parity
0
1 - 2
3-4
5-6
Mean
107
539
180
52
Patient’s Education
(School Years)
0
1 - 3
4-6
7-9
10-12
13 +
Mean
75
27
125
144
353
154
Sociodemographic Characteristics
26.8
12.2
61.4
20.5
5.9
2.2
8.5
3.1
14.2
16.4
40.2
17.5
9.0
Gestational Age
Pregnancy was terminated at 5 to 6 weeks’ gestation in 49.3 percent, at 7 to 8
weeks’ gestation in 39.7 percent and at 9 to 10 weeks’ gestation in 10.9 percent
cases (Fig 1).
Procedure Time and Hospitalisation
There was an increase in procedure time with increase in gestation^ it was 4.7,
5.8 and 6.4 minutes at 5-6, 7-8 and 9-10 gestational weeks respectively. (Table II)
and Fig 2). These differences were not statistically significant. Mean cannula
time was similar for varying periods of gestation; it was 2.4, 3.1 and 3.3 minutes
for gestations of 5-6, 7-8 and 9-10 weeks respectively (Table III and Fig 2).
All pregnancy termination procedures were performed on an outpatient basis,
women who underwent concurrent sterilisation were hospitalised.
Only
192
50
49.3
39.7
■
1
>
w
CD
CO
d
o 25
c
0)
u
CD
Ct!
10.9
0
■
5-6
7-8
9-10
Gestation (Weeks)
Fig 1
GESTATIONAL AGE OF 878 WOMEN UNDERGOING FIRST TRIMESTER ABORTION
WITH.THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST
1976 TO APRIL 1978
TABLE II
PROCEDURE TIME BY GESTATION FOR 847 WOMEN UNDERGOING FIRST TRIMESTER ABORTION WITH
THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976 TO APRIL 1978
Procedure Time
(Minutes)
< 1
2-3
4-5
6-7
8 +
Mean
5-6
N = 416
No.
__ 7O
4
1.0
201
48.3
67
16.1
43
10.3
101
24.3
4.7
Note: Data not reported for 31 cases.
Weeks1 Gestation
7-8
N = 336
_____ No.
__ %
1
0.3
91
27.1
67
19.9
49
14.6
128
38.1
5.8
10
N = 95
No.
__ %
0
0.0
21
22.1
11
11.6
17
17.9
46
48.4
6.4
9
193
Procedure Time
8
Cannula Time
6.4
5.8
co
(D
3
C
4.7
S
OJ
e
4
3.1
3.3
H
a
2.4
nJ
777
/,////
/ /// /
7777
// / / /
7777
// // ////
//
ZZZZZ,
/zzzz,
0)
s
0
'ZZZZ'
777.
7777/
77 7
777/
'////.
777/
»’zzzz>
/■zzzz,
/////.
r / / / /.
/'////'.
/ / / /.
/ s//s
//s //
"///
// / //
'//S/t
7
5-6
9 -10
8
Gestation (Weeks)
Fig 2
GESTATION BY PROCEDURE AND CANNULA TIME FOR 847 WOMEN UNDERGOING
FIRST TRIMESTER ABORTION WITH THE BATTELLE HAND PUMP AT FIVE
CENTRES IN INDIA, AUGUST 1976 TO APRIL 1978
TABLE III
CANNULA TIME BY GESTATION FOR 847 WOMEN UNDERGOING FIRST TRIMESTER ABORTION WITH
THE BATTELE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976 TO APRIL 1978
Cannula Time
(Minutes)
< 1
2 - 3
4 - 5
6-7
Mean
5-6
N = 416
No.
%
169
165
16
66
40.6
39.7
3.8
15.9
2.4
Note: Data not reported for 31 cases.
Weeks’ Gestation
7-8
N =336
____ No.
7O
81
144
32
79
24.1
42.9
9.5
23.5
3.1
9-10
N = 95
No.
%
19
44
9
23
20.0
46.3
9.5
24.2
3 .3
194
26.3
25
25.0
S
<u
CO
w
22
U-l
o
OJ
e
o
>
c
co
CD
S
19.2
19
18
1
2
3
4+
Number of Times Cannula Inserted
Fig 3.
NUMBER OF TIMES CANNULA INSERTED BY MEAN VOLUME OF ASPIRATE FOR 847
WOMEN UNDERGOING FIRST TRIMESTER ABORTION WITH THE BATTELLE HAND
PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976 TO.APRIL 1978
Technical Difficulties
Technical difficulties were reported for 8.8 percent cases. Leakage of air (5.4%)
and blockage of the cannula (1.5%) were the most frequently reported technical
difficulties (Table IV).
Technical Failutes
There were 7 (0.9%) technical failures; pregnancy could not be successfully
terminated with the hand pump and a second procedure was used to evacuate the
uterine contents. Five of these technical failures were due to leakage of air and
unsatisfactory vacuum. In one case incomplete abortion was diagnosed at the
follow-up visit and in another the reason for technical failure was not reported.
1^3
I
TABLE IV
TECHNICAL DIFFICULTIES REPORTED FOR 878 WOMEN UNDERGOING FIRST TRIMESTER ABORTION
WITH THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976 TO APRIL 1978
Technical Difficulties
Leakage of air
Blockage of cannula
Valve not functional
Pinch valve broken/dislocated
Material aspirated in shorter plastic
tube
Cannula came out of os
Push button adapter faulty
Dislocation of tube
Ring replaced
Gauge not showing pressure
Tube slipped from bottle
Connecter seal replaced
TOTAL
Number
Percent
47
13
5
3
2
5.4
1.5
0.6
0.3
0.2
2
1
1
1
1
1
1
0.2
0.1
0.1
0.1
0.1
0.1
0.1
78
8.8
Cannula Obstruction
The cannula had to be reinserted in over 60 percent cases. The rates of cannula
obstruction were similar at various gestational ages (Table V). The number of
times the cannula was reinserted increased with increase in the volume of aspirate
(Table VI and Fig 3).
TABLE V
NUMBER OF TIMES CANNULA INSERTED BY GESTATION FOR 878 WOMEN UNDERGOING FIRST
TRIMESTER ABORTION WITH THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA,
AUGUST 1976 TO APRIL 1978
Number of Times
Cannula
Inserted
1
2
3
4
Mean
5
6
N=433
No.
%
31.4
38.3
22.6
7.6
136
166
98
33
2.6
Gestation (Weeks)
7-8
N=349
No.
7O
37.5
22.6
26.6
13.2
131
79
93
46
2.7
10
9
N=96
No.
%
35.4
26.0
17.7
20.8
34
25
17
20
2.7
196
TABLE VI
NUMBER OF TIMES CANNULA INSERTED BY VOLUME OF ASPIRATE FOR 847 WOMEN UNDERGOING
FIRST TRIMESTER ABORTION WITH THE BATTELE HAND PUMP AT FIVE CENTRES IN
INDIA, AUGUST 1976 TO APRIL 1978
Volume
of
Aspirate (ml)
<
10 15 20 25 +
Mean
9
14
19
24
Number of Times Cannula Inserted
4+
2
3
N=94
N=271
N=182
No.
No.
%
No.
%
1
N-300
No.
%
40
53
29
39
139
3
11
8
13
147
6.6
18
15.5
42
13.7
37'
17.7
48
46.5
126
21.1
13.3
17.7
9.7
13.0
46.3
19.2
1.6
6.0
4.4
7.1
80.8
25.0
%
1.1
0.0
1.1
7.4
90.4
1
0
1
7
85
26.3
Note: Data not reported for 31 cases.
Complications
’ " percent cases.. Blood loss (more than
Immediate complications were reported for 1.3
100 ml) was reported for 9 (1.0%) cases. Uterine perforation occurred in 2 (0.2%)
and cervical laceration in 1 (0.1%) case (Table VII).
TABLE VII
COMPLICATIONS REPORTED FOR 878 WOMEN UNDERGOING FIRST TRIMESTER ABORTION WITH
THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976 TO APRIL 1978
Complications
Immediate:
Blood loss
Uterine perforation
Cervical laceration
Total
Early Postoperative:
Bleeding/spo tting
Bleeding requiring curettage
Fever requiring antibiotics
Total
Number
Percent
9
2
1
12
1.0
0.2
0.1
1.3
39
15
4.5
1.8
0.1
6.4
55
197
The incidence of follow-up complications was 6.4 percent. Bleeding requiring
curettage was reported for 15 (1.8%) and fever requiring antibiotics for 1 (0.1%)
case. In this series 4.5 percent of the women reported bleeding and/or spotting
at the follow-up visit (Table VII).
Complaints
The incidence of early and follow-up complaints was 3.8 and 2.5 percent respectively.
Abdominal pain (1.9%) and vomiting (1.0%) were the most commonly reported immediate
complaints. Abdominal pain (1.3%) was the most frequently reported complaint at
the follow-up visit (Table VIII).
TABLE VIII
COMPLAINTS REPORTED FOR 878 WOMEN UNDERGOING FIRST TRIMESTER ABORTION
WITH THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976
TO APRIL 1978
Complaints
Numb er
Percent
Immediate:
Abdominal pain
Vomiting
Vasovagal attack
Vertigo
Chest pain
Backache
Depression
To tai
17
9
2
2
1
1
. 1
33
1.9 '
1.0
0.2
0.2
0.1
0.1
0.1
3.8
Early postoperative:
Abdominal pain
Weakness
Leucorrhoea
Backache
Tender fornix
Discharge per vagina
Mic turition
Total
11
4
2
2
1
1
1
22
1.3
0.5
0.2
0.2
0.1
0.1
0.1
2.5
Fertility Control Acceptance
While 75.6 percent of the women had not used any method of fertility control three
months prior to the procedure, 64.7 percent accepted a method after termination of
pregnancy. In this series, 28.0, 16.6 and 8.1 percent of the women accepted IUDs,
oral contraceptives and sterilisation respectively and 3.1 percent of the husbands
accepted sterilisation (Fig 4).
Postprocedure
Preprocedure
4.0
Unknown
2] 3.8
0.2
Other
] 1.6
Conventional
3 3.0
J 3.1
13.7
Male Sterilisation
0.5
Female Sterilisation
0.1
00
CTs
75.6 [
4.4
E
Orals
1.5
[
IUD
None
8.1
116.6
28.0
35; 3
Fig 4
CONTROL ACCEPTANCE BY 878 WOMEN UNDERGOING FIRST TRIMESTER ABORTION
PRE AND POST PROCEDURE FERTILITY
_
WITH THE BATTELLE HAND PUMP AT FIVE CENTRES IN INDIA, AUGUST 1976 TO APRIL 1978
199
DISCUSSION
Pregnancy termination with vacuum aspiration is a widely accepted procedure as
it has been extensively documented to be safe and effective (2-5). With this
procedure, several variations in the type of cannula (6,7), source of vacuum,
and vacuum pressure (8) have been evaluated. However, its application in deve
loping countries has been limited essentially to urban institutions because of
its dependence on electricity. For large-scale use in rural areas, equipment
which can be operated efficiently without electrical power is needed.
Studies with the Battelle Hand Pump indicate that it can be used safely, effectively
and efficiently for terminating first trimester pregnancies. The incidence of compli
cations following pregnancy termination with the prototype equipment was low. .
Technical difficulties reported by workers testing this equipment were mostly minor.
Certain improvement in the equipment have been suggested, such as modification of the
adapter system to permit more cannula rotation without leakage of air (9). In order
to make the equipment widely available, it was recommended that this design be repli
cated locally with suggested improvements. A hand pump of the same design is
presently being developed in India.
References
1. Mullick, B., Seal, S.C. and Basu, S. 7
°
Termination
of pregnancy with the hand pump
in 200 cases at the Calcutta Welfare Hospital. Fourth
~
Transactions of Scientific
Papers, India Fertility Research. Programme, 9-16, 1977.
2. Arya3 R.D. and Paij D.N. Vented versus ruon-vented suction cannulae for first
trimester abortion. 7^
The Sixth Asian Congress of Obstetrics and GynaecologyKuala
Lumpurj Scientific Sub-Committee> 382-388, 1974.
3. Edelman^ D.A. and Brenner, W.E. An overviewLof the results of menstrual regulation
studies. Presented at the Menstrual Regulation Conference, Honolulu, Hawaii,
December 1973.
4. Pachauri, S., Kessel■, E. and Gordon, J. Menstrual regulation - Results of early
studies. 7
Proceedings of the First Scientific Conoress in Family Planning. Family
Planning Association of Sri Lanka, 194-208
’
-
•
-
.
19?5^
5. Lilaram, D., Basu, S., Khan, P.K. and Das Gupta, S. Evaluation of the safety and
efficacy of menstrual regulation and first trimester termination of pregnancy at
the Calcutta Medical Research Institute and Hospital. Third Transactions of Scientific
Papers, India Fertility Research Programme, 1-14, 1977.
6. Andolsek, L., Miller, E., Bernard, R. A comparison of flexible and non-flexible
plastic cannulae for performing first trimester abortion. Int. J. Gynecol. Obstet.
14: 199-204, 1976.
7. Moghadam, S.S., Vakilzadeh, J. and Miller, E.R. A comparison of metal and plastic
cannulae for performing vacuum aspiration during the first trimester of pregnancy.
J. Reprod. Med. 17: 181-187, 1976.
8. Mullick, B., and Pachauri, S. A cornparison of different vacuum pressures with metal
and plastic cannulae for vacuum aspiration. Fifth Transactions of Scientific Papers,
India Fertility Research Programme, 5-11, 1978.
9. Bhatt, R.V., Pachauri, S., Chauhan, L.N. and Jamshed;]i, A. Pregnancy termination
with the Battelle Hand Pump - Baroda experience. Journal of Obstet. Gynaec. of
200
STUDY OF A POSTPLACENTAL INTRAUTERINE DEVICE AT THE
NOWROSJEE WADIA MATERNITY HOSPITAL
D.N. Patel, MD, POPS, PICS1 T'
" " '
V. Walvekar,
MV, DGO, DFP2
H.B, Nariman, MBPS, DGO^
ABSTRACT
This is a preliminary report of 50 postplacental insertions of the sutured copper T-200.
No complications were reported. The expulsion rate of 6.0 percent with this device
was considerably lower than that reported in literature. These results indicate
that the chromic catgut sutures attached to the device provide an effective anchor to
prevent the expulsion of the device in the immediate postpartum period. Larger
studies are needed to document expulsion rates of the sutured Copper T-200.
INTRODUCTION
.
As the intrauterine device (IUD) requires one time motivation it is a suitable contracep
tive for developing countries. Motivation for accepting contraception is high in the
immediate postpartum period. However, the high rate of expulsion associated with postpartum
IUD insertion has been a limiting factor in making this highly effective method
available to women in postpartum programmes. Recent modifications of the IUD have
been made with the idea of increasing retention by physiological embedding of the
device in the endometrium. One such method is to provide chromic catgut sutures
as biodegradable extensions for hingiilg the IUD to the endometrium. This study was
undertaken to evaluate the effectiveness of the sutured copper T-200 when inserted
immediately after placental expulsion.
MATERIALS AND METHODS
This is a preliminary report of 50 postplacental insertions of the sutured copper T—
200 IUD in women delivering at the Nowrosjee Wadia Maternity Hospital in Bombay from
June 1979 to February 1980. Informed consent was obtained from women who requested a
spacing method and were willing to participate in the study.
The IUD was inserted within two hours of placental expulsion. In 47 (94.0%) cases
the device was inserted by hand and in 3 (6.0%) cases the inserter was used for
inserting the device into the uterus. In all cases care was taken to ensure that
the device was placed at the uterine fundus. Postnatal care provided was similar
to that for any normal case. The woman was re—evaluated prior to discharge on the
fifth day after delivery and was requested to return for a follow-up visit 20 days
after delivery and every three months thereafter. While all the study cases were
examined five days after delivery, 84.0 percent were examined 20 days after delivery
and 50.0 percent were examined at the three months follow-up visit.
1
n
Dean & Consulting Honorary Obstetrician & Gynaecologist, ^Assistant Honorary
Obstetrician & Gynaecologist, ^Medical Officer, India Fertility Research Programme,
Department of Obstetrics & Gynaecology, Nowrosjee Wadia Maternity Hospital, Bombay.
201
RESULTS
Sociodemographic Characteristics
More than half of the IUD acceptors were primiparous and were 21 to 25 years of age.
While 20.0 percent of the women in the study group were illiterate, 52.0 percent had
completed six to ten years of schoool education. The majority (94.0%) of the acceptors
were Hindus (Table I).
TABLE I
SOCIODEMOGRAPHIC CHARACTERISTICS OF 50 WOMEN UNDERGOING POSTPLACENTAL INSERTION
OF THE COPPER T-200 AT THE NOWROSJEE WADIA MATERNITY HOSPITAL, BOMBAY,
JUNE 1979 TO FEBRUARY 1980
Sociodemographic Characteristics
Number
Percent
Age (Years)
< 20
21 - 25
26 - 30
31 +
12
27
9
2
24.0
54.0
18.0
4.0
Parity
1
2
3
4
27
13
9
1
54.0
26.0
18.0
2.0
Education (School years)
0
1 - 5
6-10
11 - 15
16 +
10
4
26
9
1
20.0
8.0
52.0
18.0
2.0
Religion
Hindu
Muslim
Parsee
47
2
1
94.0
4.0
2.0
)
Expulsions
The device was expelled in three cases. Thus the expulsion rate was 6.0 percent.
In one case the device was expelled within three days of insertion. In the other
two cases it was expelled within two weeks of insertion. T|le reTnaining 47 women
continue to wear the IUD,
202
Complications and Complaints
The only complaint reported was^ the
This complaint
(24?0%) cases and was due to the presence of the nylon thread of the device in the
This symptom disappeared when the string was cut shor
CONCLUSIONS
After reviewing our experience with IUD insertions m/his and previous studies
conducted at this institution we feel that postplacental IUD insertion is easier
than subsequent insertion. However, motivation prior to insertion is difficult
as the concept of postpartum IUDs is still new to the women attending this
institution.
insertions with the multiload, Cu-250, postpartum T and Lippes
evaluated at our institution, the expulsion rate was 40.0 percent.
preliminary respite of
this stedy
showed that
that the
the expulsion
expulsion rate
rate »a. significantly
of this
study showed
lower
The expulsion rate
with this
this device
device was
was also
also 1much
lower than that reported
' i with
--- —
i:“herXrO,2>. It
It appears
appears that
that the
the catgut
sutures are
ar. effect vo for anchoring
catgut sutures
the device to the endometrium and prevent its expulsion in the postpartum
period
Larger studies are needed to document the effectiveness of the sutured
SS
u..,«««.
Copper T-200.
ACKNOWLEDGMENT
■ - to> the India Fertility Research Programme
The authors wish to express their gratitude
for sponsoring the situdy and providing the devices.
References
experience in postpartum family
1. Zatuehni, G.I. Overview of program: Two year . Edited by G.I. Zatuchni> McGraw
planning: A report of the International program
Hill Book Company, Hew York, 1970.
Apelo, R^ Ramos, R., and Thomas, M.. The LEM device in an immediate postpartum
contraception program. Per til. Steril, Vol. 279 No. 5, May 1976.
203
MATERNAL AND NEONATAL MORBIDITY AND MORTALITY WITH PREMATURE
RUPTURE OF MEMBRANES - THE ROLE OF PROPHYLACTIC ANTIBIOTICS
M. Kochhar, DGO3 FRCOG, FRSCE
7
Manjit Kochhar^ MD
9
ABSTRACT
This study was conducted to study the incidence of neonatal and maternal mortality
and morbidity following premature rupture of the membranes and to evaluate the ro e
of prophylactic antibiotics in preventing maternal and neonatal infection in sue
cases.
The neonatal and maternal mortality rates for the study group were 4.0 and 2.4 percent
respectively. The incidence of neonatal and maternal infection increased with time
after the rupture of membranes. For maternal infection rates these differences were
statistically significant. The incidence of neonatal infection was lower by 20 5
" ' cases who did
percent and that of maternal infection was lower by 10-20 percent for
receive antibiotics as compared to those who did. This suggests that prophylactic
antibiotics are not indicated in these cases.
INTRODUCTION
Although premature rupture of membranes is a common obstetrical complication, its
potential as a maternal and foetal hazard generally tends to be overlooked and
which have been proposed for determining the presence or absence of mf
. ^°U
be used as valuable screening devices for the early detection of this potentia y
hazardous condition which can be treated effectively.
This study was undertaken to: (1) determine the incidence of infection in the mother
and the newborn based on bateriological and/or histopathological evidence and
(2) evaluate the role of prophylactic antibiotics in preventing maternal and neonatal
infection.
MATERIALS AND METHODS
Case Selection and Categorization
Data are reported on 125 women who delivered at the Kasturba Hospital in Delhi from
August 1977 to January 1978 with uncomplicated rupture of membranes and no other
obstetrical complications. The study cases were categorised into the following groups.
Medical Superintendent, 2General Duty Medical Officer, Department of Obstetrics
and Gynaecology, Kasturba Hospital, Delhi.
204
Group I
- Group I was the control group which consisted of 25 cases in whom
started within 12 hours of rupture of membranes.
Group II
- Group II consisted of 50 cases in whom membranes had ruptured 12 to 24
hours prior to the onset of labour. This group was further subdivided
into Group II-A and Group II-B each consisting of 25 cases.
labour
Group Ill - Group III consisted of 50 cases in whom the membranes had ruptured 24
hours or more before the onset of labour. This group was further sub
divided into Group III-A and Group III-B each consisting of 25 cases.
Antibiotics were administered to both the mother and the newborn in
Groups II-A and III-A but not to those in groups II-B and III-B. To
achieve a random pattern in as far as possible, every alternate mother
and newborn received prophylactic antibiotics. The mother received
0.5 gm of streptomycin with 4 lac units of penicillin intramuscularly for 7
days (after a test dose). The newborn received one lac units/kg of body weight
of crystalline penicillin 12 hourly after a test dose and 5 mg/kg of body
weight of garamycin intramuscularly, 8 hourly for 7 days.
Infection Criteria:
Infection in the mother was detected by the following methods:
1. Culture of a high vaginal swab for aerobic and anerobic organisms, In case of
a positive culture, an antibiotic sensitivity test was put up against the
isolated organism.
2. Histopathological examination of the umbilical cord, placenta and membranes.
Leucocytic infiltration was considered as histopathological evidence of infection.
Infection in the newborn was detected by the following methods:
1. Culture of the venous blood (taken from the femoral vein) for aerobic and
anerobic organisms.
2. Culture of the gastric aspirate.
3. Cell count of the gastric aspirate, A smear was considered to be positive
when there were 5 or more polymorphs per high power field.
Both the mother and newborn were followed up for seven days after delivery, The
criteria for maternal infection was a temperature of 38°C or more at any time
and/or local infection in the form of a foul smelling lochial discharge. The
criterion of neonatal infection was the presence of any sign or symptom of septicemia
within the first seven days of birth.
All statistical tests were performed using a significant level (p value) of 0.05.
205
RESULTS
Neonatal Mortality and Morbidity
There were five neonatal deaths; of these 4 were from group II-A and one was a control
case. The neonatal mortality rate for the series was 4.0 percent. Neonatal mortality
increased with increase in time after rupture of membranes and was highest after
24 hours when the incidence was doubled.
The incidence of neonatal infection for the series was 26.4 percent. Infection rates
for Groups I, II and III were 20.0, 26.0 and 30.0 percent respectively (Table I and
Fig 1). However, the differences were not statistically significant*
The
neonatal infection rate was higher for infants who received prophylactic antibiotics
than for those who did not (Fig 2).
TABLE I
INCIDENCE OF NEONATAL INFECTION IN VARIOUS GROUPS AT THE KASTURBA HOSPITAL,
DELHI, AUGUST 1977 TO JANUARY 1978
Group
Infection
Number of Cases
No.
%
I - Control Group
25
5
20.0
II - Rupture of membranes
within 12 to 24 hours
50
13
26.0
III - Rupture of membranes
after 24 hours
50
15
30.0
TOTAL
125
33
26.4
Maternal Mortality and Morbidity
There were 3 deaths in this series; all 3 cases belonged to group III A.
mortality rate was 2.4 percent.
The maternal
The incidence of maternal infection for the series was 22.4 percent. Infection was
documented bacteriologically in only 7 cases. The incidence of of maternal infection
increased by time; it was 12.0, 16.0 and 34.0 percent in Groups I, II and III
respectively (Table II and Fig 2). There was a significant difference in the incidence
206
30.0
30
■
■
26.0
sW
■
■ iO;
■
■
■
20.0
w
0)
CD
05
U
15
a
CD
O
xW:::::
s
III
W::;
<D
PU
0
Control
12-24
24 +
Group Rupture of Membranes
(Hours)
Fig 1
INCIDENCE OF NEONATAL INFECTION BY TIME IN VARIOUS
GROUPS AT THE KASTURBA HOSPITAL, DELHI,
AUGUST 1977 TO JANUARY 1978
TABLE II
INCIDENCE OF MATERNAL INFECTION IN VARIOUS GROUPS AT THE KASTURBA HOSPITAL,
DELHI, AUGUST 1977 TO JANUARY 1978
Group
Infection
Number of Cases
No.
7.
I- Control Group
25
3
12.0
II- Rupture of membranes
within 12 to 24 hours
50
8
16.0
III- Rupture of membranes
after 24 hours
50
17
34.0
125
28
22.4
TOTAL
/
207
Antibiotics
NEONATAL
MATERNAL
No Antibiotics
48.0
44.0
•:W
sssss
40
WS?
ms
32.0
EW!
cn
CD
cn
nJ
u
C
CD
O
28.0
iW:-::
Bl
ft:::::::::;::
20.0
20
77^
✓z
11 "///,
7,
<D
P-<
11 7' / / S
/s//
11 Jzzzzz
7,,,,
■
■
Os
11
Bi
16.0
&& ,
0
IB
11 ''77
111 ''<<<
12
- 24
Bl ”
:11s
9^^
1B
■I
Bl
11 777
•11 ',7,7,
20.0
SSI
zzzz
<ZZZ
11
••S:
’SS 4.0
X’XvXv
24 +
12 - 24
//////
S 7////,
•Xv.’.w zzzz
SSSx
zzzz
^7//A
>
s/ / /
SSSS /.
/ //////
SSSx z/zz
Y//.
XwJvX zzzzZ?
ryfzzzzz/
/
Z
‘ ■ • //
’//
24 +
Rupture of Membranes (Hours)
Fig 2
INCIDENCE OF NEONATAL AND MATERNAL INFECTION WITH AND WITHOUT ANTIBIOTICS
BY TIME IN THE STUDY GROUPS AT THE KASTURBA HOSPITAL, DELHI, AUGUST
1977 TO JANUARY 1978
of infection in groups II and III (Table II and Fig 3). The incidence of maternal
infection was significantly higher for women who received antibiotics than for
those who did not (Fig 2).
.
208
40
34.0
'////.
/////.
' / s/s.
'////<
////'.
/////,
////'.
'////.
'////,
CD
0)
CD
05
o
' s / / s.
'///'.
'////.
20
16.0
a
CD
O
12.0
0)
777^
0-4
//✓✓/
/✓✓✓/
•////»
•////.
0
/////
//////
// //
7777‘
//'//.
/////.
'////.
'////.
' s / / s.
7/77/
77/.
777'
‘
'/ / / s •
7777/
'/s ///
f////.
f/ / / /4
»////.
•////.
'////.
'////.
•////.
•////.
'////.
'////.
'////.
f// / /.
7///,
7/77
////*
'///s.
/s.
’////.
’////.
’////.
Control
1 2-24
24 +
Group Rupture of Membranes (Hours)
Fig 3
INCIDENCE OF MATERNAL INFECTION BY TIME IN VARIOUS
GROUPS AT THE KASTURBA HOSPITAL, DELHI,
AUGUST 1977 TO JANUARY 1978
DISCUSSION
A review of available literature, shows a considerable variation in opinion regarding
risks related to premature rupture of membranes and to the management of this
condition. Spontaneous rupture of membranes often heralds the onset of normal
labour, but when the membranes rupture without prompt onset of labour, an entirely
different set of consequences results.
In this study, the incidence of neonatal infection was found to be independent of
time after rupture of membranes. Similar observations were made by Habel et al (1).
The neonatal morbidity rate (26.4%) for the present series was lower than that
reported by Pyrles et al (31.0%) (2) but was considerably higher than that
reported by Taylor et al (4.3%) (3) and Habel et al (3.0%) (1). When the membranes
ruptured before 24 hours, the neonatal infection rate was 30.0 percent in this series,
In this study, there was a 10 to 20 percent higher rate of infection among infants
who received prophylactic antibiotics than among those who did not. While Pryles
et al (2) made a similar observation, Calkins (4) observed a reduction in the
incidence of foetal infection when penicillin was administered prophylactically.
Equivocal results were reported by other workers (1, 5).
209
This study showed an increase in neonatal mortality with increasing time after
rupture of membranes, especially after 24 hours when the mortality rate doubled.
Burchell also showed a doubling of neonatal mortality after 24 hours, and a second
doubling was reported during the next 24 hours (6). Breese (7) observed a three
and a half times increase and Eastman (8) observed a three fold increase in neonatal
mortality 48 hours after the membranes ruptured. Other workers also showed an
escalation in the neonatal death rate every 12 hours (9-11). Bishop (12), however,
observed a slight decrease in both stillbirth and neonatal death rates in cases of
premature rupture of the membranes.
In this study, prophylactic antibiotic therapy did not decrease neonatal mortality.
Similar results were reported by Breese (7) and Kent et al (13). Lebherz et al (14)
showed very little difference in the mortality rates of patients who received or
did not receive antibiotics.
In this series. the incidence of maternal infection was seen to increase as the time
between the rupture of membranes and onset of labour increased. Similar reports
were made by other researchers. In contrast to this, Lebherz et al showed that
maternal morbidity did not increase significantly with premature rupture of membranes
(15). Woltz observed that there was no maternal morbidity within 24 hours of
rupture of membranes and after 24 hours, there was no definite relationship between
duration of rupture of membranes and maternal morbidity (16).
In this study, the incidence of maternal infection was found to be significantly
higher in patients who received prophylactic antibiotics as compared to those who
did not, suggesting that prophylactic antibiotic therapy is not warranted in these
cases. Similar observations were made by other workers who showed similar maternal
morbidity rates for patients who received antibiotics and those who did not (6, 7,
16, 17). The maternal mortality rate (2.4%) in this series was higher than that
reported by Schulze (18), who reported no maternal mortality, but was lower than
that reported by Bishop (5.1%) (12). The study suggested that prophylactic antibiotics
do not prevent maternal and neonatal infection in uncomplicated cases of premature
rupture of membranes.
References
1. Babel, A.L., Sandor, G.S., Conn, B.K. and McCrae, W.M. Premature rupture of
membranes and effects of prophylactic antibiotics. Archives of Dis. of Childhood,
47, 401, 1972.
2. Pryles, C,V.3 Stelg^ N,H.j Nazr^ S.± GeltzsS.S. and Tenney3 B..A controlled
study of the influence on the new born of prolonged rupture of membranes, and/or
infection in the mother. Raed. 31, 608, 1963.
3. Taylor, B.S., Morgan, R.L., Burns, P.D. and Drose, V.E.
membranes.
Spontaneous rupture of the
Am. J. Obstet. Gynec. 82, 1341, 1961.
4. Calkins, L.A. Premature spontaneous rupture of the membranes.
Gynec. 64, 871^ 1952.
5. Bound, J.P., Butler, N.R. and Spec ton, W.G.
Am. J. Obstet.
Classification and causes of perinatal
mortality Part II. Factors in pregnancy and labour influencing perinatal mortality
Br. Med. J. 2, 1191 and 1260, 1956.
210
Am. J. Obstet,
6, Burchellj R.C, Premature spontaneous rupture of membranes.
Gynec. 64, 871, 1964.
7. Breese3 M.W. Spontaneous premature rupture of the membranes.
81, 1086, 1961.
Am. J. Obstet. Gynaec.
8. Eastman, N.J. Unpublished discussion of article by Roth, L.G. Management of
ruormal pregnancy labour and puerperium, early rupture of membranes. Significance,
aetiology and prognosis. Obstet. Gynec. Survey, 10, 14, 1966.
9. Both, L.G. Early rupture of membranes.
Obstet. Gynec. 4, 87, 1954.
Significance, aetiology and prognosis.
10. Embrey, M.P. Premature rupture of membranes.
LX, 37, 1953.
J. Obstet. Gynaec. Brit. Emp.
11. Webster, A. Management of premature rupture of membranes.
Survey, 24, -485, 1969.
Obstet. Gynec.
12. Bishop, E.H. The prognosis and management of premature rupture of the membranes.
Am. J. Obstet. & Gynec. 48, 45, 1944.
13. Kent, S.P. and Widerman, G.L. Prophylactic antibiotic therapy in infants bom
after premature .rupture of membranes. J. of Am. Med. Assoc. 171. 1199. 1959.
14. Lebherz, T.B., Hellmen, L.P., Modding, H., Anchit, A. and Aye, S.L. Double
blind study of premature rupture of membranes. Am. J. Obstet. Gynec. 87,
218> 1963.
15. Lebherz, T.B., Boyce, C.R. and Huston, J.W.
Am. J. Obstet. Gynec. 18, 658, 1961.
Premature rupture of membranes.
16. Woltz, J.H.E., and Zintel, H.A. The transmission of penicillin through the
placenta. Am. J. Obstet, Gynec. 49, 663, 1948.
17. Sanqalong, G.A.
930, 1957.
IB. Schulze, M.
Premature rupture ' of membranes.
Dry labour.
Am. J. Obstet. Gynec. 83,
Am. J. Obstet. Gynaec. 17, 20, 1929.
211
DESIGN OF THE COMMUNITY-BASED PROJECT
FOR SOUTH KANARA DISTRICT
,7
T. Rcandas M. Pai, MBPS'
ABSTRACT
I
The project design for a community-based programme of contraceptive distribution
and family planning surgical services for South Kanara District is described.
Oral contraceptives will be provided through 301 distribution outlets spread over
the district. The role of depot workers and supervisors in the programme is
explained. Menstrual regulation and other services will be provided at minimal
charge by* trained rural medical practitioners. It is envisaged, that after the
initial inputs, the programme will become a self-supporting distribution system.
INTRODUCTION
The project is designed for community—based distribution of oral contraceptives
and for provision of family planning surgical services to eligible couples in the
South Kanara District. It aims to supplement the ongoing programmes and to saturate
the area with family planning services by popularizing the use of IUDs, condoms,
menstrual regulation (MR), oral contraceptives, and medical termination of
pregnancy.
This project will be funded for 3 years by the Family Planning Foundation,
will be implemented by the Kasturba Medical College, Manipal and will be monitored
and evaluated by the Jan Mangal Samastha.
The South Kanara District has coastal, hilly and forest areas and thus provides
a wide range of conditions for testing the system for future large-scale replication
in the country. While 18.5 percent of the couples in this state are protected
by sterilisation, only 1.3 percent use IUDs and 0.8 percent use other methods
including oral contraceptives.
According to the 1971 census the population of this district was 1,939,315. It is
expected to increase by 19.4 percent in 1981 when it will be 2,315,000. There are
8 taluks, 18 towns and 663 villages in this district which has two medical schools,
15 hospitals, 76 dispensaries and 20 primary health centres with a total bed
strength of 2,934.
This Project aims to establish a self-sustaining distribution system for:
1. social marketing of oral contraceptives through trained community workers
by using marketing management technique supported by reasonable cash sales
commissions and
2. provision of family planning surgical services, specifically for MR through
trained local medical practitioners who will receive fees which are within
the capacity of the beneficiaries .
*Medical Director, Kasturba Medical College Hospital, Manipal.
212
PROJECT ORGANIZATION
Community-Based Distribution of Contraceptives
Through this project, 301 distribution outlets will be established to cover the entire
project district. Each outlet will cover a population of 5,000 in sparsely populated
areas and 10,000 in densely populated, coastal areas. Trained local women will serve
as depot workers incharge of these outlets. These depot workers will register all
eligible women in their areas. In low density areas, the depot workers will receive
Rs. 0.75 per couple registration and Rs. 0.75 as sales commission for each pill cycle
distributed. In the high density coastal areas, the depot workers will receive Rs. 0.50
per couple registration and Rs, 0.60 per pill cycle distributed. The monthly income
of the depot worker from the sale of pills is estimated to be Rs. 283.00 in coastal
areas and Rs. 177.00 in other areas.
There will be one supervisor to supervise ten depot workers, The supervisor will
receive a monthly salary of Rs. 250.00 plus Rs. 100.00 for travel. He will also receive
Rs. 0.05 to Rs. 0.10 (coastal/rural areas) as commission on sale of pills, It is
estimated that the monthly income of the supervisor will be Rs. 486.00. At a later stage.
sale at cost or with subsidy will be considered for other contraceptives such as condoms
and foam tablets and for simple medicines used to treat common ailments. While the
depot worker will receive two weeks training in family planning methods, marketing and
record-keeping procedures, the supervisors will be trained for one week in family
planning methods, marketing and management. Orientation training in the field will
be provided to these personnel every six months.
Community-Based Services for Menstrual Regulation
MR services will be provided in the district through 75 rural medical practitioners
who will be trained in family planning methods and specifically trained to perform the
MR procedure. They will also be supplied with MR kits. These practitioners will receive
a moderate remuneration for performing MR and MTP and for inserting IUDs. An expert
medical team from the Kasturba Medical College Hospital will visit them periodically
to ensure that they receive adequate medical support from the Government health agencies
and also from enlisted medical practitioners.
Headquarters Office
The Medical Director of the Kasturba Medical College will be the Project Director.
Other staff of the Headquarters Office will include a project manager, an assistant
manager, a secretary, accounts assistant, typist, attendant and driver. There will be
two technical advisory committees—A Biomedical Committee and a Marketing Committee—
represented by senior members from the appropriate professions in the district and also
government health representatives.
CONCLUSION
As it is privately managed, this project will have considerable flexibility. It is
envisaged that by complementing present services in the district, this project will
saturate the area with family planning services and will, thereby, assist in reaching
as yet unreached rural populations in the district.
213
MONITORING AND EVALUATION OF A COMMUNITY-BASED DISTRIBUTION
PROGRAMME
S. Basu, MPH1
ABSTRACT
The monitoring and evaluation system based on the Community-based Distribution (CBD)
Programme for oral contraceptives in Howrah District in West Bengal is described.
A simplified record keeping system is recommended. Data may be evaluated using manual
and/or computer analysis to produce performance measures needed for assessing programme
achievement.
INTRODUCTION
The monitoring and evaluation system for a programme for the community-based distribution
(CBD) of oral contraceptives (OCs) described in this report is based on the record-keeping
system designed and pretested by the India Fertility Research Programme (India FRP).
This system generates routine service statistics necessary for the management and
evaluation of CBD programmes. These service statistics can be produced by using a
combination of manual and computer analyses and provide programme administrators with a
simple and efficient means of producing the performance measures necessary for assessing
the success of the programme in meeting its specific goals.
THE RECORD SYSTEM
In 1977, a pilot CBD programme of oral contraceptives (OCs) was conducted in the District
of Howrah in West Bengal. Based on the evaluation results of this programme, a
simplified system of record-keeping has been developed by the India FRP. This system
requires the depot holder to maintain only two records—the Couple Contact Register for
registering all couples contacted and an Issue Sheet for recording pill cycles distributed
during the month. The Issue Sheet which comprises of the Admission and Follow-up
Issue Sheets is the basic form used for programme evaluation. The following is
a description of the record system recommended by the India FRP for monitoring and
evaluation of CBD programmes.
The Issue Sheet
The depot holder completes the Admission and Follow-up Issue Sheets and submits them
to the Project Office each month. Appendix I provides a sample of these forms and
the instructions for completing them.
The Admission Issue Sheet is completed only for new acceptors starting OCs during the
month. Data recorded for each new acceptor include her pill card number (a number
assigned serially to acceptors),day of visit and number of pill cycles provided. Upto
a maximum of three client characteristics such as age, parity and present contraceptive
T-------
Study Coordinator, India Fertility Research Programme, Calcutta.
•
214
practice can also be recorded on this form. Specific client characteristics
can be selected. In accordance with the legal requirements, the acceptor signs
against each pill cycle received.
The Follow-up Issue Sheet is completed for all old cases who return for a resupply
of OCs or are readmitted into the programme. The data recorded on this form include
pill card number, day of visit, number of cycles supplied and the date of next visit.
The pill card number is preprinted serially on the Follow-up Issue Sheet to enable
the depot holder to detect clients who fail to visit the clinic on their due date
during any specific month. Acceptors who fail to visit the clinic for a resupply
of OCs within the month have blanks against ’day of visit’, ’no. of cycles supplied’
and ’the due date of next visit’. At the end of the month, the follow-up Issue
Sheets are examined to note preprinted pill card numbers with blank data.
Thus,
the drop-outs can be identified. These constitute the priority group of cases who
should be followed up by tbe depot holder. By matching their pill card numbers,
these cases can be traced back on previous Issue Sheets to confirm the dates of their
last visits and the due dates of their next visits. The depot holder makes home visits
to contact cases who are overdue for a depot visit to motivate them to continue OCs.
For clients who discontinue OCs, the reason for discontinuation is recorded by the
depot holder on the Code Csrd (Appendix II).
Information on the stock of oral contraceptives are recorded by the depot holder
on the lower, section of the Follow-up Issue Sheet to account for supplies received.
The contact number of the last eligible couple contacted by the depot holder is also
recorded in this section of the Follow-up Issue Sheet.
The Couple Contact Register
“
A Couple Contact Register is indexed alphabetically
likej a telephone directory, so
that couples contacted can be traced by name. This register is maintained by the
depot holder to record particulars of all eligible couples (14 - 35 years) contacted.
Information recorded in this register includes the name and address of the couple,
their contact number and three client characteristics. The Pill Card Number is
recorded only-in case the woman accepts OCs (Appendix III).
The Pill Acceptor Card
A Pill Acceptor Card is provided by the depot holder to each new acceptor and is
kept with the acceptor. It serves as an identity card which she is expected to
produce each time she visits the depot for a resupply of pills. The depot holder
- -'
, the acceptor’s
records identification information, including
the
pill card -number,
of visit and the
name, and her husband’s name and address on this card. The date
--- -Instructions
to take the pill
due date of her next visit are also recorded. Z
—-------- on
-- how
are printed on the Pill Acceptor Card (Appendix IV).
The depot holder completes the Couple Contact Register for all couples that he/she
contacts. If neither the husband or the wife have been sterilised and if the wife is
not using OCs or the IUD, the depot holder motivates her to use OCs. If the woman
accepts the method and has no contraindications to OCs, the depot holder requests
her to visit the depot during her next menstrual period or at the earliest possible
in the event that she has lactational amenorrhoea. She is assigned a pill card
number when she visits the depot for her first supply of OCs. This number is also
215
recorded in the Couple Contact Register. After disbursement of a cycle of OCs, the
depot holder completes the Admission Issue Sheet and prepares a Pill Acceptor Card
in duplicate. The client is advised the due date for her next visit in accordance
with the visit calendar (Appendix V). Visits to the depot by old continuing cases
or readmission cases for resupply of pills are recorded on the Follow-up Issue Sheet.
The following is a description of records maintained at the Project Office fori the.
systematic monitoring of the CBD programme:
The Control Card
The Control Card,a key record for monitoring, summarizes the progress of the depot
and shows at a glance, the various statistics of records and supplies as well as payments
made to and revenue collected from the depot. The upper section of this card provides
detailed particulars on the geographical location of the depot, its identification
by state and district, opening date of the depot and hours the depot operates. The
lower section of the card provides summary information on the cumulative number of
couples contacted, number of new, continuing, readmission and discontinuing acceptors,
stock of pills received and balance in hand, and accounts of payments and revenue
(Appendix VI).
The Data Control Slip
Data Control Slip is attached to the Issue Sheets submitted by the depot holder and
is completed every month at the Project Office to verify and note the number and
types of records submitted by the depot holder (Appendix VII).
The CBD Records Flow Sheet
When documents are received at the Project Office for data processing and filing,
the Records Flow Sheet is completed to log by Depot Number, all incoming sets of records
during the month and to take note of those depots that fail to submit their records
(Appendix VIII).
The Document Sheet
The Document Sheet when completed and tallied at the end of each month shows the total
number of OC cycles distributed and the number of new acceptors for all depots included
in the programme (Appendix IX).
216
PERFORMANCE MEASURES
The following performance measures are used to evaluate programme achievements:
The Monthly Progress Report
This report shows the cumulative number of couples contacted each month and the
cumulative and monthly number of new acceptors and OC cycles distributed at all depots
included in the programme. It provides statistics on the current status of the
programme and compares it to achievements of past months (Appendix X).
Prevalence Rate
The prevalence rate specifies what proportion of the eligible women contacted are
continuing OCs at given time intervals of programme operation. The prevalence rate
after ’n’ months of programme operation is calculated by dividing the number of
continuing acceptors by the total number of eligible couples registered after ’n’
months of programme operation.
Continuation Rate
The continuation rate indicates for a given point in time, what proportion of women
in the programme are continuing OCs among women who ever accepted OCs. The continuation
rate is calculated for each depot in the programme after 3, 6, 12, 18 and 24 months
of operation.
Graphs for Programme Monitoring
The following six graphs are maintained at the Project Office to measure progress of
the programme at the depot, thana and the district levels:
1. New and discontinuing acceptors of OCs by month and year for each depot.
2. Continuing users of OCs by month and year for each depot.
3. New and discontinuing acceptors of OCs by month and year for each thana.
4. Continuing users of OCs by month and year for each thana.
5. New and continuing acceptors of OCs by month and year for each district.
6. Continuing users and prevalence of use of OCs by month and year for each district.
The Monthly Programme Performance Indices (PPI) Record is maintained by state, district,
thana and depot number (Appendix XI). This record enables calculation of monthly prevalence
217
rates and continuation rates and plotting of the above-mentioned graphs, The
information on the PPI form is derived every month from the Issue Sheets.
If funds are available, the processing of the Issue Sheets may be computerized
to produce monthly PPIs for each depot and the various performance rates. However,
the Issue Sheet can also be processed by hand. In this event the Follow-up
Issue Sheet is perforated beyond the column for ’Due Date of next visit’. It
can be torn off from here to remove the columns for ’Day of visit’ and ’Number of
cycles supplied’. These columns are pasted against the appropriate Pill Card
Number on the Acceptor Follow-up Chart (Appendix XII). The number of continuing,
discontinuing and new acceptors can be calculated each month from the Acceptor
Follow-up Chart. Thus, the various performance measures can be generated by
computer or .manually for programme monitoring and evaluation.
APPENDIX I
HEW ADMISSION ISSUE SHEET
(To be ocapletod for Hew Aaoeptore only)
State
<
Mn.
Depot
i
r^-n
I i ;
A
Qfolae
Pill Card Day of «PJ>*
Ht>.
v^al ,
i.
Coople
Charaotegiatlca
None A UAfua/
AsooBtor’a akanatoye
mu mrum k^^ch piiogkahms
CBD PaOGRAMMK
State
Jto.
Diet.
No.
Month
Tm*
FCLIDW-OT ISSWS SHSMf
PU1 Cavd
Na.
Due Date
few next
▼left
j&ooptor's Slgnaturo
Sato of
thia
visit
Cyolea aoppllod/
reaeon far
dlaeontlnoatlon
i
stock ar oiul pxu
A. It atart of nonth
B. aaoelvad thia month
C. Total thia month (A+B)
Oral Pillo
• ••••
a. aiatributod thia month
& Balance at end of month
The Last Contact 30* aaaignod thia montt^
ooftpletod couple oontaota In area
............. ..... ........*....
c=
V
Date
r
APPENDIX II
...
■ ■•
■
■■ •:
:
"
.
r
INDIA fektilhy rkeargh programme ,.
Community .-J^SQ.d ^istribut'ipn of' Con^aeptiveb
f
; v";/ ■
•
': <O.r
for'
’
-
/
fieasjons for discontinuatiofc of pill
I
^W<'
*
Reasons for dig continuation
CodQ No.
. •
1
Unplanned Pregnancy
2
Menatrual Side effeots including, pain -
3
Other medical reasons
4
Planning
Planning Pregnancy
Pregnancy - ^$<FFP
- iV . t. 3
5
Personal reasona/husband away from home -
♦
- ‘'^r^a
v
*-
iJSsw.y^KlW*.
(7?IW
s®)w
6
Moved from arha
7
k of pins,
Programme Specific reasons(lack_of
pills, cost ooff pills,
sProblems with services) .^x^'
.
\5^T^
■'^W"
- ^'rr^-^n'^TA-jr ^ar^NT^Si ’XTthW^
8
Switched to another method
— --
9
Unknown
.„.-■
\5-TT
<W
*2^
V.
>i
£*4
1
W^TX?
<UpReeo^
w
^S-rW^
i
4
C ^4^07
5rt
f issue she-e-tT^ sggfeffW
ck no^s ?;n Cc.r& NoX^ygp^
< Prww Sodus’’
-9,5* 1N irniter VHl C^el&s Su.pf>tt*d ’
1 o \ W^CFT^
1
■■-4.S'-
1
!
^a,F,R.P,/CBD gro,jec4r/ Followup-.Visit Calendar/1979.
\3
1
2
3
I MON
*J1
j TUES
5
M26
•6
7
A23 F<jr21
J148
9
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4
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1 .PRI
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FJ
MJ
' SUN
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F4
1 MON
I-------J TUES
J8
J9
WED
8
11
12
13
.14
NJ...
^3
13
310
Sil
N6
D4
JI
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J2
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SI? Octll
^8
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J5
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Agl7
S14 Oct 12
N9
17
J4
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A28 Hy26
Ju2J
Jy21
Agl8
S15 OotlJ-
N1O
re
J5
M4
*A1
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Ju24
Jy22
Agl9
S16 0ctl4
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B9
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Jy25
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S17 Oct 15
N12
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J7
F6
M6
AJ
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Jy24
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Oct 16
NIJ
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M
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321
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| SUN
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1^6
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| SUN
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Ag7
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Oct2 Oct 30
N27
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M21
Al©
Myl6
Jul 3
Jyll
As6
95
OctJ OctJi
N28
D26
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A19
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Jyl2
Ag9
36
Cct4 *f?l
N29
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M2 3
A20
Myl8
Jul5
Jyi3
Agio
S7
Oct 5
N2
NJO
D28
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38
Oct6
N3
♦DI
?»9
J26
FRI
SAT
J27 F24
M24
A21
Myl9
J28 F25 M25
*J-Januaiy, F-February
A22
My20
| SUN
Jul 6
Jyl4
^3
Agll
1
J1O
FRI
1
16
J28
Jul7 JyiS Agl2 S9
D2
D30 J2T
N4
M-Maroh, A-April, Uy-May, Ju-June, Jy-July, Ag-August, S-September,
Oot-October, N-Navember, ]>»December.
APPENDIX III
HOU yKHTILITY HES&uiGH HlOGUmg
OSD raOGRANMB
coons COMTAOT REGISTKK
DISTRICT
MPor so.
yas THS MO»ra.
Maa> aM Addyaa
r
Ooupia
Coutaot
»«
nu
Patlaat
CtaagaotartaUqa
—sa_
Cazd
Marta*
Day o£
Oon>
APPENDIX IV
India mmm HEsi*ocn. pK0GrA>3
CBD PHOGliAMME
:ILL ACC1T?® CARD
PHI CARD NO.
»
»
CCOUPLK CONTACT NO,
♦
•
Husband*0 Naae
Wife’s Nawei
Address
Depot Name
&
Address
Depot No.
Clinic Hours
Name of Depot Holder
Instruction cn Pill Usei
Instruction for Follow-up Visit!
follow-vp visrr
Today’s
■ato
No. of
Cycles
Hemaric
Due Date
for next
—
Today’s
Date
No. of
Cycles
liemark
Due Aits
for next
-------
APPENDIX V
ranw &&& ^5
Rm 1
:■
, 9
1
2
MON
* JI
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M26
A23
^21
juia
Jyl6
I TUES
—
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A24
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Jyl7
AgU
| WED
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JJl
F28
M28
A25
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'THURS
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*F1
*M1
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Ny?4
! FRI
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F2
M2
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SAT
J6
5*5
MJ
MJl
I SUN
J7
*4
M4
MON
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F5
T.UEB
J9
; WED
35
4
35
7
6
8
10
11.
12
j(14
15
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t l£
16
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315
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M.Y25
JU22
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S14
Oct 12
N9
17
J4
A28
My26
Ju2J
Jy21
Agl8
S15
OotlJ
N1O
IB
J5
*A1
A29
Ny27
Ju24
jy22
Agl9
0ctl4:
Nil
M5
A2
AJO
Mfr 28
Ju25
Jy25
Ag2O
S!7
Dotl5
N12
DIO
J7
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_ ________________________________
*J-Janua.ry, F-February, M-Maroh, A-April, &V-Mayf Ju-Jun©, Jy-July, Ag-August, S-Septembei*,
Oct-October, N-November, D-December.
i SUN
■
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INDIA TEKTILHY... RESEARCH PROGRAMME
Community -Based Distribution qf Contraqe.ptives
. *1:’ •7 • I •CODE WJ
‘
;
FOB "" ;
?
Reasons for discontinuatioil ®f pill
Codp No.
Rflaqpng fpy discontinuation
1
Unplanned Pregnancy
2
^.fenstrual Side effects including pain •
5
Other medical reasons
4
Planning Pregnancy -
5
Personal reasons/husband away frpm heme
6
Moved from arba
7
Programme Specific reasons(Lack of pills, cost of pills,
Problems with services)
8
Switched to another method -
9
Unknown -
•-
.
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APPENDIX VI
INDIA FERTILITY RESEARCH PROGRAMMj/COMMUNITY BASED DISTRIBUTION OF CONTRACEPTIVES/CONTROL CARD
Di•Pill Diatbn.started
State
!
D ot Holder
P.O
19
i
m
Clinic Hrs
m to
Bly. Stn<
Dist.
Au^ress
Bus Route
Closed on.
Day
G
An
ress.••••••••••
Th
Dist.• Depot No. « T
Pay Reve
Cumu.Couple
PILL STOCK
ACCEPTOR
ment nue
contacted Uontg.
1
| DisStart
Bal- to DH to CBD
L_te till this last New Re^ Total con- Conti of Rece
Month Adm. Adm. Accep tng. -nuing Mnth ived Total Dish.ance This this
Mth/Yr month
month month Remarks
APPENDIX VII
mix nRTn.xrr research prooramme
DATA COnBOL SUP
BATCB 10.
Ta
T
I
T
T
ncwsous
sun io.
1. Total So. Bw Adalsaioa
ZMmo Sbaato
DISTRICT 80.
2. Total So. ItoUokKup
laaoa Shaeta
DEPOT SO.
job xoan OF
' <
APPENDIX V^II
DISTRICT
STATE
Cea- Cum.
tee
Few
x»3U mrxxjTT rwamh mxam
OGXBDC FLOW S»m3
TtooJ
Couples Oto
Cpntd. to» <to»
toti| toa
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c
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APPENDIX IX
arOA F^tflLITT O51MCH PKUGiUmS
CBD WOEKaiT 3Bg*g
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c«tttse ■MHMV •
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1
2
3
4
5
6
7
8
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2
3
4
9
6
7
8
9
o
APPENDIX X
CBD PROGRAMME
MONTHLY PROGRESS REPORT
Month
pin Cumulati
no. of
Cumulati- _ PILL ACCEPTORS
Distri ve Pills
ve CR com-’ New aooe- Cumula
Centres
buted
distribu
tive
opened
pleted
ptors
ted till
acoptrs.
this
till this till this this
this month
month
month
this monlh Month
month
I
CBD PROGRAIIME (HOWRAH)
PROGRAMME PERFORMANCE INDICES
State J Dist.
Thana
Depot
Ct
1977
July
A
S
0
N
D
1978
J
F
II
A
M
APPENDIX XI
J
J
A
0
S
N
D
1979
J
F
M
A
M
J
A
M
J
Couple Registration
Old Contng.
Re-Adm.
ACCEPTORS
New Acceptors
Total
Acceptors dis cont ini', li'7
Continuing Acceptor;?
I
Prevalence of Use
State
Bist.
Thana |
Depot
1977
July
A
S
0
N
D
1978
J
F
M
A
M
Couple Registration
Old Ccntng.
ACCEPTORS
Re-Adm.
Nevz Acceptors
Total
Acceptors discontinuing
Continuing Acceptors
Prevalence of Use
1
1
I
I
I
J
J
A
S
0
N
D
1979
J
F
M
--
■
•
-..,44
APPENDIX XII
State
Bist. ’Thana
Depot
ACCEPTOR FOLLOW-UP CHART
i
Calender Month
Pill Card
No.
Page -
C7R7
No.
j—
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