Acceptability and Continuation Rates of 2 Monthly Injectable Contraceptive Norethisterone Enanthate
Item
- Title
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Acceptability and Continuation Rates of 2 Monthly
Injectable Contraceptive Norethisterone Enanthate - extracted text
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Final Report of the Project
Acceptability and Continuation Rates of 2 Monthly
Injectable Contraceptive Norethisterone Enanthate
Protocol Amendment - DEXA Study
(Funded by Department of Family Welfare, MOHFW, Govt, of India)
Project Co-ordinators
Pervin Meherji, Officer-in-charge
Chander Puri, Former Director
Principal Investigator
Shanta Chitlange, Scientist 'F'
Senior Statistician
Donta Balaiah, Scientist 'F'
Co-ordinating Centre
National Institute for Research in
Reproductive Health (ICMR)
2
NATIONAL INSTITUTE FOR RESEARCH IN REPRODUCTIVE HEALTH
(Indian Council of Medical Research)
Jehangir Merwanji Street
Parel, Mumbai 400 012.
1
Site Investigators and Participating Centres
Site Investigators
Participating Centres
1.
Shanta Chitlange
Kamal Hazari
Lalita Saverdekar
NIRRH (ICMR), Mumbai
2.
Dr. V Salvi,
Prof., Dept. ofObst. & Gynae.
Dr. K Mathur,RO
KEM Hospital & G.S.
Medical College,
(ICMR unit), Mumbai
3.
Dr. H Saini, Prof. & Head,
Dept, of Obst. & Gynae.
Dr. J Kashyap, RO, HRRC, ICMR
S.S.G.S. Medical College,
(ICMR unit), Baroda
4.
Dr. D Kalavalli
Superintendent & Prof,
Dept. ofObst. & Gynae
Dr. Christe, RO, HRRC, ICMR
RSRM Govt. Hospital,
(ICMR unit), Chennai
5.
Dr. J J Mallick, Prof. & Head,
Dept. ofObst. & Gynae.
Dr. S Nayak, RO, HRRC, ICMR
S.C.B. Medical College,
(ICMR unit), Cuttack
6.
Dr. A Bhargava, Prof & Head,
Dept. ofObst. & Gynae.
Dr.M Gupta, RO, HRRC, ICMR
S.M.S. Medical College,
(ICMR unit), Jaipur
7.
Dr. T K Ghosh, Prof. & Head,
Dept. ofObst. & Gynae.
Dr. A Chanda, RO, HRRC, ICMR
IPGMCR & SSKM
Hospital, (ICMR unit),
Kolkata
8.
Dr. C Doifode
Dr. C. Sarodey
Prof. & Head, Dept. ofObst. & Gynae.
Govt. Medical College,
Nagpur.
9.
Dr. S. Salhan, Prof. & Head,
Dept. ofObst. & Gynae.
Dr. H S Gaikwad, RO, HRRC, ICMR
Safdarjung Hospital,
(ICMR unit), New Delhi
}
2
Table of Contents
Description
Page No.
Acknowledgement
4
Summary
5
Introduction and Rationale
8
Objectives of the Study
10
Formulation and Injection Schedule
10
Study Design
11
Enrollment and Follozu-up Procedures
12
Database Management and Statistical Analysis
13
Results
14
Menstrual Pattern Among Injection Net-En users
16
Changes in Body Weight observed during Injection Use
17
Women's Attitudes/Perceptions toivards Injectable Contraceptive
19
Return of Fertility following Drug Discontinuation
20
Counselling Issues & Management of Irregular Menstrual Bleeding 22
Information to the Participants and Informed Consent
28
Protocol Amendment - DEXA Study
31
DEXA Study Findings
33
Conclusion of the Study
33
Acknowledgement
34
References
35
List of Tables and Figures
37
Tables and Figures
39-69
3
Acknowledgement
We sincerely acknowledge the Department of Family Welfare, Ministry of Health
and Family Welfare, Government of India, for providing financial support
to conduct this study. We sincerely thank Dr. M S Jayalakshmi, Deputy
Commissioner from the Ministry for having considered the extension of the study.
We are grateful to Dr. Harbansing Juneja, Dr. Chander Puri, former Directors, and
Dr. Pervin Meherji, Officer-in-Charge, National Institute for Research in
Reproductive Health, for their continuous support and encouragement in
conducting the study. We express our gratitude to Dr. S S Agarwal,
Dr. Usha Krishna, Chairpersons and Dr. Kamal Hazari, Member Secretary of the
Institute's Ethics Committee (IEC) and all the members of IEC for their valuable
inputs in defining and monitoring to ensure the conduct of this study with regard
to the ethical issues. We thank all the site investigators for their continuous
co-operation throughout the study. Lastly we thank all the study participants
who accepted injectable method and continued to give valuable information.
4
Summary
The Family Planning Programme of India offers limited contraceptive choices like
IUCD, oral pills, male condom, tubal ligation and vasectomy. There is substantial
unmet need of 13% for contraception of which about 50% is for spacing methods
(NFHS 3, 2005-06). It is essential to increase the range of contraceptive choices to
fulfil this unmet need. Long acting injectable Contraceptives viz. 2 monthly -
Norethisterone Enanthate (Net-En) and 3 monthly - Depot Medroxyprogesterone
Acetate (DMPA) are available in Indian market since 1993, but have not been
introduced in the National programme because of opposition from women's
health group. In view of this, at the initiative of the Government of India, the
Institute had carried out a multi centre study to obtain more recent data on
2 monthly injectable contraceptive (Net-En). A total of 1209 healthy women aged
between 20-40 years with proven fertility and at least having one living child were
enrolled across India. The objectives were: i) to assess acceptability/continuation
rates of Net-En; ii) to evaluate the incidence of side effects like menstrual
irregularities and weight gain; iii) to study women's attitude/perceptions towards
injectable and iv) to study return of fertility following discontinuation of injection.
The injections were offered under cafeteria approach giving balanced information
about all the contraceptive methods available in the National Family Welfare
Programme (NFWP). The major emphasis in this study was on good counselling
by qualified staff providing quality contraceptive services, ensuring informed
choice and consent. The duration of injection Net-En in this study was two years.
At discontinuation of the injection, women were interviewed to know their
perceptions towards this method. Women who desired pregnancy following
discontinuation of injection were followed up for 1 to 2 years for return of fertility.
The observations based on 17268 women months of injection use show cumulative
continuation rates of 65%, 53.6% and 48.3% at the end of 12,18 and 24 months
respectively. The major discontinuations were due to personal reasons, lost to
follow-up and migration because of floating population. The method related
discontinuations like menstrual disruptions; weight gain and pregnancies were
observed in 15.5% of women at the end of study period of two years. The method
was found to be very effective since there were only three pregnancies reported
during 2 year of injection use. About 89% women said that injections should be
made available through National programme, since the method is more
convenient compared with daily intake of oral pills, does not have effect on breast
5
milk, offers a wider choice of Family Planning (FP) methods etc. The method was
well accepted by majority of the women, thus can fulfil the unmet need for
contraception. Over 79% were satisfied with the use of this method and also
recommend this method to their friends and relatives. About 39% requested to
provide them further injections after completion of the study. Based on these
study findings, the Government of India will consider introducing injectable in the
programme.
A total of 150 women desired to conceive following discontinuation of injection.
Of these, 75.33% conceived within 9 months whereas 24.67% conceived between
10 to 23 months respectively after the washout period of the drug. There were 135
full term deliveries with healthy newborns at birth, 12 women underwent
pregnancy termination with tubal ligation and 3 women had first trimester
spontaneous abortion.
Injectable and Bone Mass Density (BMD):
Some recent reports have shown that the bone mineral density (BMD) decreased
in adolescent women aged 14 to 18 years who used the 3 monthly injectable
contraceptive - Depot medroxyprogesterone acetate (DMPA). However, after
stopping the injection, BMD increased (Arch Pediatr Adolesc Med. 159(2): 139-44,
2005). It is not yet known whether bone loss due to use of DMPA leads to
osteoporosis and risk of fracture in later life. Based on these reports, Pfizer
Company, manufacturer of injection DMPA in agreement with USFDA inserted
‘Black Box’ warning label on the use of injection DMPA in November 2004. The
warning suggests that the use of DMPA causes a significant loss in BMD, which is
greater with increasing duration of drug. Therefore, injection DMPA should be
used as a long-term birth control method (more than two years) only if other birth
control methods are inadequate/ unacceptable and in this case the woman should
be evaluated while taking the drug long term.
In May 2005, the issue of ‘Black Box’ warning with DMPA use was raised by the
"All India Democratic Women's Association" and was communicated to the
Health Secretary and also in the media. In view of this an urgent meeting of the
Institute's Ethics Committee (IEC) was held on 17th May 2005. The ethics
committee discussed all these issues and available literature reports on BMD,
6
which mainly reported on injection DMPA. The committee also emphasized that
the duration of injection Net-En use in the study is for 2 years. The committee
approved the following plan of action:
i.
The additional parameter of DEXA for assessing bone density be carried out
as soon as possible in all the women who are still using injection Net-En.
ii.
The DEXA investigation will be repeated every six months during injection
Net-En use and one year after stopping.
iii.
These amendments were for all the participants at all the centers where
DEXA was done locally.
Though the baseline levels of the BMD in these women (prior to initiation of
injection Net-En) are not available, this will reassure the women about their bone
density status.
Accordingly, a total of 142 women still using injection Net-En underwent BMD
evaluation by DEXA at hip and lumbar spine. Of these, 73 women underwent
repeat DEXA scan at 6 months interval after receiving 3 more injection. Similarly,
109 women had DEXA scan done one year after stopping the injection.
Healthy women (n=59), who did not use hormonal contraceptives and were
matched with respect to age and parity comprised the control group for DEXA
study. The findings showed that with the increasing use of injection there was no
decrease in mean BMD. Similarly; there was no significant change in mean BMD
observed among injection users compared with control group. These findings are
reassuring.
The findings of this study have shown that skilled counseling by qualified staff,
quality of services in the family planning clinics helped clients to continue
injections in spite of menstrual disruptions. There were inter-centre variations in
continuation rates of injections. There was no significant decrease in BMD
observed among injection users compared with control group. The other factors
like Body Mass Index (BMI) had significant effect on BMD as observed in the
study.
7
Introduction and Rationale:
Contraception is an integral part of ser\ Ices provided to improve the health of the
family. Although, the contraceptive prevalence rate has increased in the recent
years, there is however a substantial unmet need of 13.2% for contraception,
of which about 50% is for spacing methods among eligible couples (NFHS-3,
2005-06). The fact that annually 78% conceptions are unplanned and 25% are
unwanted is the good indicator of this unmet need. About 18% maternal
morbidity/ mortality is related to the induced abortions. All efforts should be
made to meet the unmet need of contraception of the eligible couples by
expanding the contraceptive choices in our National Family Welfare Programme
(NFWP). It is necessary to maximize access and quality of services to increase
contraceptive use to make the programme more effective.
At present, in the cafeteria approach within the NFWP, the spacing contraceptive
methods offered are intra-uterine contraceptive device (CuT 380), combination
oral pills and male condoms. Injectable contraceptives like 3 monthly, Depo
medroxyprogesterone acetate (DMPA) and 2 monthly Norethisterone Enanthate
(Net-En), have been registered in 179 and 91 countries respectively. Globally,
about 32 millions of women are using injectable contraceptive (Population
Reports: Series K, Jan-Feb. 2007, Fig.l).
The Indian Council of Medical Research (ICMR) had generated considerable data
on these injections in mid 1970s and early 1980s. Both these injectables (DMPA &
NET-EN) are available in the Indian market since 1994 after USFDA approved
injection DMPA for contraceptive use in the United States in 1992. At present
some of the private sectors and social marketing agencies provide 2 monthly and 3
monthly injections to women at subsidized cost. These injections have not been
introduced into our NFWP due to the issues raised by women's health group.
In view of prevailing concerns, a workshop was jointly convened by the Institute
and Government of India in December 1998. The objective of the workshop was to
review the status of injectables (2 monthly and 3 monthly) in the neighboring
Asian countries vis-a-vis that in India and to debate the pros and cons of their
introduction into the NFWP. A majority of the delegates were in favour of
introducing injectables into the NFWP. However, in the Indian context it was
emphasized that injectables should be introduced gradually in a phased manner
8
with emphasis on good clinical practices and counseling issues, suitably in well
equipped centers.
A Chinese study (Lei Zhen-WU 1996) has shown that structured counseling
before initiation of injectable contraceptive substantially increased the
continuation rate of the method as shown in the following figure.
Term ination rates of DM PA (Chinese study)
100 -i
c
0)
90
80
70 -
E
o
5 60
w—
O
o
-Q
E
3
z
Routine counseling group
50
40
30
20
10 /
0th—
Baseline
-■-Structured counselling group
Month 3
Month 6
Month 9
Month 12
Cumulative termination rates - 11% (23/204) and 42% (92/217)
respectively (p< 0.0001), Source: Contraception. 53, 1996
The idea of offering injectable contraceptive as a method of contraception is to
widen the choices of contraceptives available for women. None of the available
contraceptives is 100% effective, or completely free from side effects. However the
side effects are more of an inconvenience than life threatening. The risk of
morbidity and mortality associated with unwanted pregnancies must always be
weighed against the side effects of contraceptive methods, which are much less.
Injectable contraceptives can be used as a long-term or short-term (2-3 months)
method. They can be of use to women whose spouses visit them for short
duration. They can be ideal contraceptive after vasectomy when contraception is
required for 2 to 3 months till husband's sperm count becomes zero. Women who
are breast-feeding, and cannot take oral pills or use intrauterine contraceptive
devices can use injectable contraceptives.
9
With this background information, at the initiative of the Government of India, the
Institute had undertaken a multicentre study on "Two monthly injectable
contraceptive Norethisterone Enanthate (Net-En)". The major emphasis of this
study was on counseling by qualified staff.
The objectives were:
i.
To assess user acceptability/continuation rates of injectable contraceptive
NET-EN
ii.
To evaluate the incidence of menstrual irregularities and other side effects
iii.
To assess user's attitudes/perceptions towards injectable contraceptive
iv.
To study return of fertility in eligible women
Formulation and Injection Schedule:
Norethisterone Enanthate (Net-En) is a two monthly injectable contraceptive
containing a synthetic hormonal progestrogen, which resembles the natural
female progesterone. Each dose contains 200 mg of hormone in an oily base. The
injection is marketed as Noristerat in a 1ml ampoule and manufactured by
Schering AG. The drug is released at a relatively constant rate into the blood
stream from the site of injection after an initial peak level (serum levels between
10-20 mg/ml) and provides the users with a safe and highly effective from of
birth spacing method.
NET-EN is a highly effective contraceptive method. The 200mg dose of NET-En
is most commonly used in a 2-month schedule. The range of efficacy quoted for
NET-EN is 0.01-1.3 per 100 women years.
The drug has to be inject deep
intramuscularly.
Mechanism of action:
•
Primarily stops ovulation (release of eggs from ovaries).
•
Effect on endometrium - decreases receptivity to blastoclyst/fertilized ovum.
•
Thickens cervical mucus, making it difficult for sperms to pass through.
10
Injection schedule:
First injection:
1. Regular menstrual cycle: upto 7 days (days 1 through 7) of the menstrual cycle.
2. Post-partum, breast feeding women after 6 weeks from delivery.
3. 1st trimester spontaneous or induced abortion immediately or upto 5 days.
4. 2nd trimester abortion, after 6 weeks
5. Change of contraceptive method :
i. Intra-uterine contraceptive device users-immediately if removed during
menses (1-7 days), otherwise women were advised to come after next
period.
ii. Combination oral pills - the interval between last active pill and injection
should not exceed 7 days.
Grace period for subsequent injections :
Net-En can be given upto 1 week late or early. Ideally women should be
encouraged for re-injections on scheduled time. If given during grace period,
provider should be reasonably sure that woman is not pregnant. Pregnancy needs
to be excluded by history, pelvic examination or urine pregnancy test if necessary.
Study Design:
This is a multicentre study, which was initiated at 9 centers in June 2002 after
having extensive review by the Institutional Ethics Committee (IEC). Each
participating centre was asked to obtain local Ethics Committee approval and to
enroll a minimum of 120 women participants over a period of 12-18 months.
Women attending the family welfare clinics/gynaecological OPDs in public
hospitals and requesting for spacing methods were given balanced presentation
on all available contraceptive methods in the programme including 2- monthly
injection Net-En. Healthy women between 20-40 years of age, having at least one
living child, willing to sign an informed consent form and accessible for follow
ups, and who met eligibility criteria were given detailed written information on
injection Net-En including its advantages and disadvantages (please see information
and informed consent for the participants pages 28-30). The women with following
medical conditions were excluded from the study.
11
Exclusion Criteria:
Breast feeding women < 6 weeks post-partum
Known or suspected pregnancy
Unexplained/ abnormal vaginal bleeding
Active liver disease and h/o Jaundice within 6 months of enrollment
Known or suspected malignancy
Cardio-vascular disease
H/o cerebro-vascular stroke
Focal migraine headaches
Any chronic medication including corticosteroids (except nutritional supplements)
Known allergy to any hormonal preparation
The major emphasis in this study was on good counseling by qualified staff and
quality care services. All the health providers from the participating centers were
trained to strengthen counseling and motivational skills through pre study and
midterm workshops conducted at the Institute. The nurses were trained for the
injection technique and safe injection practices. Counseling guidelines were
prepared for implementation at various stages of use i.e. at initiation, during
treatment and after discontinuation of the method and also management of
common side effects (see pages 22-27 for counselling issues and management of
side effects).
Enrollment and Follow-up Procedures:
The information for the participants included all the advantages and
disadvantages of injectable contraceptive. Thus a total of 2352 women after
screening for inclusion and exclusion criteria were found to be eligible for injection
Net-En, of these 1209 (51.4%) women accepted injection under the cafeteria
approach after signing an informed consent form (Fig.2). The remaining 1143
(48.6%) women desired other available rpacing methods in the programme (Please
see flowchart for recruitment (Fig. 3). The reasons for refusal of this method are
listed in table 1. The commonest reasons were, frequent visits to the clinic for
repeat injections (27.8%) and anticipated side effects like irregular menstrual
periods and weight gain (17.4%). Some women also expressed fear of developing
male characteristics (0.5%). The women were interviewed at discontinuation of
injection/ termination of the study by the qualified staff to know their views and
12
attitudes towards this method. This is essential to determine the needs of the
potential users before the method is introduced into the National Programme.
A thorough physical and pelvic examinations were done at enrollment including
weight, height, blood pressure, haemoglobin, routine urine sugar and albumin.
Pap smear was done at enrollment and thereafter at 1 to 2 years wherever facility
existed. They received injection Net-En 200mg deep intramuscularly every 2
months, with a grace period of 7 days was permitted (either early or late). They
were given menstrual diary card to record symbols for menstrual bleeding as
instructed. The dates of subsequent injections were mentioned at the back of the
menstrual card. One menstrual card was also kept with the case record form and
information from the menstrual card given to the woman was transcribed into the
card kept in the clinic.
Follow-up Procedures:
i. Each woman was followed up for scheduled injections as mentioned under
injection schedule for a duration of 2 years.
ii. At each follow-up visit the menstrual diary card was completed and symptoms
related to method recorded and appropriate counseling was given.
iii. Blood pressure, weight record, breast and pelvic examinations were done
every 6 months and as relevant.
In case of amenorrhoea, (> 6 weeks) pregnancy was excluded by symptoms, pelvic
examination and urine pregnancy test if necessary before administering
subsequent injection.
All women participants were interviewed at discontinuation of the injection.
Thereafter women who wished to conceive or did not accept contraceptive
method in the respective clinics were followed up every 3 months for upto 2 years
to study return of fertility.
Database Management and Statistical Analysis:
The data entry and verification of the data has been carried out before tabulation
and analysis. The statistical methods used were: descriptive statistics for the
variables like age, weight, haemoglobin, body mass index, and bone mass density
etc. Life table technique was used for calculation for continuation rate as described
13
in the book entitled "Epidemiologic approach to reproductive health" CDC
Atlanta
Georgia,
USA
PHI
and
WHO*
Geneva,
Switzerland,
WHO/HRP/EPI/1994. Chi square statistical test was applied to observe the
centerwise continuation rates of injection and the educational status of the women.
The definition, classification and analysis for menstrual pattern was followed by
the methodology adopted by Dr. S. Datey (ICMR) and Dr. Belsey et al. WHO. The
proportions among various groups has been shown in the bar diagram for
comparing the difference between the various groups.
Correlation analysis is used to test the significant relationship between Bone Mass
Density (BMD) and Body Mass Index (BMI), changes in body weight,
haemoglobin estimation and other related variables.
Unpaired t-test is used to test the significance of mean difference of BMD between
the variables like age group, breast feeding status, number of children etc. and
control group vs. injection users.
Paired t-test (before and after) is used to study the significant difference of mean
BMD at femoral neck and lumbar spine between injection users compared with
injection discontinuers. Descriptive statistics were used for the data of return of
fertility.
Results:
Socio Demographic Profile of the Participants:
The women were from low-mid socio-economic strata. The demographic profile of
these women is shown in table 2 and figures 4a, 4b and 4c respectively. The mean
age of the participants was 24.97 and body mass index (BMI) ranged between 13.6
to 38.7. About 71% women attended secondary and higher secondary schooling
while 15.4% of the participants were graduate and postgraduate. The family
income of the study participants per month ranged between <Rs.l000/- to
>Rs.l0,000/-. Of the 1209 women participants enrolled, 518 (42.8%) received their
first injection within 7 days of the regular menstrual period (interval group),
whereas 438 (36.2%) received 6 weeks after delivery (post partum group) while
remaining 253 (20.9%) received their first injection concurrent with surgical
abortion (post MTP group).
14
Contraceptive Use prior to Participation in this Study:
Of the 1209 women acceptors, 721 (59.64%) women had used one or more
contraceptive methods prior to accepting Net-En, whereas 488 (40.36%) women
accepted injection Net-En as their first contraception (Fig. 5a). The methods of
contraception used in the past were, intra-uterine contraceptive device (34.26%),
condoms (31.8%), Oral pills (25.9%), Injectable/Norplant (4.3%), withdrawal
/Natural Family Planning (3.5%), failure of tubal sterilization (0.28%), as seen in
Fig. 5b. It was interesting to note that women who used injectable in the past
accepted injection Net-En. They could not continue using injections because of the
high cost.
The number of women who had received between 1 and 12 injections during a 2year study period is shown in histogram (Fig.6). The observations are based on
17268 women months of use of injection Net-En. Cumulative continuation rates of
injection Net-En using a life table technique at the end of 12,18 and 24 months
were 65%, 53.6% and 48.3% respectively (Fig.7). There were significant inter-center
variations in continuation rates as seen in Table 3. Continuation rate of injection at
1 year was significantly higher (P<0.05/at the centers from Nagpur and Chennai
compared to other centers. Similarly 1 year continuation rate of the injection at the
center from Jaipur was significantly higher (P<0.05) compared to the centers at
Baroda, Mumbai and New Delhi.
A 2 year continuation rate at Chennai and
Nagpur was significantly higher compared to other remaining centers. Within the
3 FP clinics of NIRRH, although the settings and staff structure is similar, there
were inter-clinic variations in continuation rates. These differences could be due
to the counseling skills of the providers, presence of medical doctors to look into
the side effects of the method and also cultural/ethnic differences. In one of the
Institute's Family Welfare clinics, the counseling was so effective that in spite of
irregular menstrual pattern/frequent bleeding, some of these women had no
complaint and there were few discontinuations for menstrual irregularity.
The education of the women did not have impact on a 1 year continuation rate of
the injection as seen in table 4 whereas a 2 year continuation rate was signicantly
higher (p<0.05, Chi Square) among women having upto secondary schooling
compared to those who were graduates and post graduates.
15
The various reasons for discontinuation of injection in a 2-year study are depicted
in table 5. The majority of the discontinuations were due to personal reasons and
lost to follow-up/migration because of floating population. These were mainly
reported during first 6 months of the injection because these women requested for
1 or 2 injections. It was interesting to note that 5.95 of women who were waiting
to undergo tubal ligation had accepted this method and postponed surgery for
tubal ligation. About 4% of women had suffered from other medical illnesses like
Tuberculosis, Hepatitis A, Skin rash. Headaches, Malaria etc, and were
discontinued from the study. There were 2 accidental deaths not related to
injection, reported during first 6 months of study from 2 centres (KEM hospital,
Mumbai and Chennai). Only 15.54% of women discontinued due to method
related causes like menstrual disruption, weight gain and method failure. A total
of 3 pregnancies (method failures) were reported from the centers at NIRRH
Mumbai (1 pregnancy) and Baroda (2 pregnancies). The woman participant from
NIRRH Mumbai, probably conceived during 2nd injection since her pregnancy was
detected at the time of 3rd injection. The remaining two pregnancies reported from
Baroda, who had their 1st injection following medical termination of pregnancy.
The pregnancies were detected at the time of 3rd injection.
Menstrual Pattern among Injection Net~En Users:
"A bleeding/spotting episode is defined as requiring the use of a pad or other protection".
Each woman had maintained the record of bleeding episodes on menstrual diary
card as instructed. A sample menstrual diary card is shown below.
National Institute for Research in Reproductive Health
Menstrua! Diary Record
Centre No.
Name :
Year
Day ►
Month ▼
2
3
4
5
6
8
9
Serial No.
10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
I
••••••
xxiw
||
Symbols : B-bleeding, P-profuse bleeding, S-spotting, l-injection, to be transferred on to the menstrual card from subjects diary card
Symbols for Subject : X-bleeding, XX-profuse • spotting
Checked by Dr.
16
Signature
For the analysis of the menstrual pattern, a 90 days reference period was
considered and the statistical programme was developed based on the WHO
guidelines by Belsey et al (1986) and modified as per Datey et al (1995). The
following definitions were considered. Prolonged and frequent bleeding patterns
were clubbed together for the analysis purpose.
Definitions of Bleeding Patterns:
a) Prolonged bleeding
:
b) Frequent bleeding
c) Infrequent bleeding
At least one bleeding/ spotting episode lasting
more than 14 days
More than four bleeding/ spotting episodes
during the reference period.
:
One or two bleeding or spotting episodes.
e) Amenorrhoea
No bleeding / spotting days during the reference
period
f) Regular pattern
Three to four episodes of bleeding or spotting
each lasting about five to seven days.
Thus a total of 5666 reference periods were studied during a 2 year injection use.
It was observed that through out the study period the infrequent bleeding
(oligomenorrhoea) pattern was most commonly seen whereas regular or
acceptable bleeding pattern was observed among 13.4% and 12.9% of women
during the reference period at 1 and 2 years respectively. The frequent and
prolonged bleeding pattern was observed only in 6.2% and 4.8% of women during
these reference periods respectively. There was increase in amenorrheic pattern at
the end of 2 years of injection use (37.7%) compared to 27.2% during the reference
period at 1 year (Fig.8). It was observed in this study that infrequent bleeding
pattern was well accepted by the women after counseling.
Changes in Body Weight observed during Injection Use:
A total of 709 participants had repeat weight record at the end of 1 year while 417
women had at the end of 2 years of injection use respectively. Although majority
of the women (62.9%) had weight gain at 1 year of injection use, there was no
significant increase in mean body weight compared to their body weight recorded
17
before initiation of injection. The weight loss was also observed in about 16% of
women although it was not significant compared to their body weight before
injection use. Similarly, the increase in mean weight was observed in 76.5% cases
at two year of injection use, although it was not significant (Fig.9a & 9b). The
increase in body weight was perceived as positive health effect by some of the
women who were having low weight prior to injection use.
Overall Effect on General Well-Being:
At the discontinuation of injection, a total of 968, women were asked direct
questions pertaining to certain side effects of the injection, although none of them
directly complained about these side effects since they were well informed and
counseled prior to participation. About 55.7% of women had some of the
following side effects like weight gain (21.6%), lethargy (20.6%), bloatedness
(18.9%), irritability (15.2%), mood changes (13.7%), backache/leg pain (6.5%) and
breast tenderness (3.5%) although there were no discontinuations for these effects
(Fig-10).
Changes in Cervical Cytology (P^p Smear) observed during a 2 Year
Study Period:
Repeat cervical cytology observations were available in 550 women at 1 or 2 years
of injection use. There was no significant change in the cervical cytology observed
during the study period compared to their pre-injection cytology (Table 6).
Haemoglobin Status OfNet-En Users:
The haemoglobin (Hb) of the participants was done before initiation of injection
and repeated at 1 or 2 years of injection use wherever it was feasible. Most of the
women refused to have their haemoglobin done at follow up visits to avoid
second prick (pricks for injection and Hb estimation) as informed by the centres.
Therefore, the repeat haemoglobin values were available in 229 women.
The
observation shows that there was increase in mean Hb in most of the women
(56.77%) whereas decrease in Hb was observed in 16.59% women although these
were not significant. There was no change in Hb observed in 26.64% of women
(Fig.ll).
18
Women's Attitudes/Perceptions towards Injectable Contraceptive:
(Please see table 7 for questionnaire and responses)
All the participants were interviewed at admission to assess their knowledge,
perceptions & attitudes towards injectable contraceptive.
Knowledge about Injectable Contraceptive:
Of the 1209 women enrolled, 723 women (59.8%) had not heard or knew about
injectable prior to participation in this study, whereas 486 (40.2%) heard about this
method from their friends or relatives who had used injectable (54.8%), health
personnel (41.2%), private doctor (14.8%) and media (5.6%) as shown in Fig.l2a &
12b. Surprisingly many of the health care providers were not knowledgeable
about the method. When women were asked about their concerns regarding this
method after having read full information on injectable, 25% of women feared
about the effect of injection on future fertility, quantity of breast milk, effect on
blood pressure, HIV transmission through repeated needle pricks and fear of
genital cancer. This reflects the need for good counseling, alleviation of fears,
information, education and knowledge about injectable contraceptive.
At discontinuation/termination of the study, a total of 968 women were
personally
interviewed by the qualified social
staff through structured
questionnaire. The majority of the participants (79.6%) were, satisfied with the
injectable contraceptive, while 20.4% were not satisfied because of the menstrual
disruption they experienced during injection use. Over 80% of the women found
two monthly injection schedule convenient to take as against like taking daily
pills. It is important for users to remember the dates of subsequent injections. In
this regard 51.1% of women referred to menstrual cards on which the dates of
subsequent injections were written. When asked about whether women will like
to take 2 monthly or 3 monthly schedule of the injection. Majority of the women
(59.4%) said that they would like to take 2 monthly schedule because of the
experience of this injection during the study (Fig.13). In response to question on
"change in menstrual pattern", 89.9% of users had experienced change in
menstrual pattern, still majority of them continued using injections after good
counseling and this change was acceptable to both the(,spouses (74%).
It is reported that hormonal contraception particularly oral pills decreases libido in
women. In this study 88.3% of women reported no' change in sexual behavior
19
r
particularly coital frequency as many couples abstain from sexual intercourse
during menstrual bleeding.
Over 89% of women expressed that injection should be available through National
Family Welfare Programme because of the convenient schedule and everyone can
afford and access the method and also it will widen the choices of contraceptives
(Fig.14).
Majority of the participants (79.4%) also said that they would
recommend this method to their friends/relatives. The reasons were "one is
carefree for 2 months" and do not have to memorize to take daily pills. Some of
them also felt that the method is private, it causes less pain during menses and this
can be viewed by women as positive health effect (Fig.15). About 60.4% said that
they would be able to pay for the injection if the method cannot be made available
free of cost (Fig.16).
It was interesting to note that about 3^% of women requestecl to provide them
injections beyond the study period of 2 years (Fig.17). In this regard the matter
was discussed with the Chairman of our IEC and they recommended that the
participants should be provided injections on service basis. Subsequently some
women received additional 3-4 injections depending on its availability at each
centre.
Return of Fertility following Drug Discontinuation:
Women desiring pregnancy or who did not accept contraceptive in the clinic after
discontinuation of injection (after the wash out period of drug) were followed up
every 3 months for return of fertility over a period of 2 years. Thus a total of 150
women who desired pregnancy were eligible. The pregnancies were confirmed
either by urine pregnancy test or ultrasonography. Over 74% of the women
reported pregnancy within 9 months of drug discontinuation. Although,
conception was delayed in about 12% of women beyond 1 year following
discontinuation of injection, no woman had requested for the investigations of
delayed pregnancy. These women conceived between 13 to 23 months following
drug discontinuation. Of the 150 women, 135 continued pregnancy till term and
had normal babies at birth, 3 women had first trimester spontaneous abortion,
whereas 12 women underwent surgical abortions (MTP). These women wanted to
continue injections beyond study period hence did not accept other contraceptives
available in the programme. They underwent concurrent tubal legation following
abortion. Had we continued injections in these women, they would not have had
20
unplanned pregnancies. There was no difference in timing of conception between
women who discontinued injection for planning pregnancy compared to women
who discontinued for other reasons as stated in following figure & table.
Return of fe rtility fo Ho w in g dru g
dis co n t'n uatiori (n=150)
30.00
27.33
24.67
25.00
c
CD
20.00
£*-•
15.00
CD
Q
10.00
E
CD
Q.
■I
23.33
■
12.67
12.00
1
5.00
0.00
1-3
4-6
7-9
10-12
Months after drug discontinuation
Full term deliveries - norm al new(borns
Induced abortions witu tubal ligation
Spontaneous abortions
13 +
1 35
12
3
Return of fertility compared with reasons for
discontinuation of injection Net-En (n=150)
Reasons for
discontinuation
Number (%)
Return of fertility in months
following drug discontinuation
Desired pregnancy
109 (72.67)
1 to 23*
Personal reasons
18(12.00)
1 to 19
Irregular / Prolonged
bleeding____________
8 (5.33)
1 to 9
Other medical reasons
6 (4.00)
1 to 9
Amenorrhoea
4 (2.67)
1 to 19
Late for injection
3 (2.00)
7 to 19
Weight loss / Weight gain
2(1.33)
4 to 9
* One woman conceived 23 months after drug discontinuation
21
Counselling Issues and Management of Irregular Menstrual Bleeding:
The workshops were conducted by the Institute for the health care providers from
participating centers to strengthen motivational and counseling skills pertaining to
injectable contraceptive. The training was focused on the following key points on
counseling. Nurses were trained for injection technique and safe injection
practices.
Key Points on Counseling for Injectable Contraceptive:
Initial Visit:
What clients expect?
Composition of injectable contraceptive
How it acts
Efficacy and safety
Who can take
When to initiate
How often (interval)
Privacy
Side effects of the method
Advantages of the method: (providers should inform)
■
■
■
No daily intake e.g. pills
Very effective & safe
Privacy can be maintained
■
Not coitus dependent
■
Can be used at any age
■
No effect on quantity and quality of milk, can be used by nursing mothers as
early as 6 weeks after delivery.
■
Can be used by women with certain medical diseases since no estrogen
component in the drug.
22
Non Contraceptive Benefits:
May prevent pelvic inflammatory diseases / ectopic pregnancy
May prevent endometrial cancer, sickle cell crisis'
May prevent iron deficiency anaemia (refer to menstrual changes)
Disadvantages of the Method:
Inform clients about common side effects (assure that these are not a sign of
disease)
Changes in menstrual cycles are unpredictable for individual woman
Initial light/heavy menstrual bleeding and subsequent amenorrhoea
Weight gain, headache, breast tenderness
Delay in return of fertility
Counselling during Use of the Method:
•
Assurance for irregular menstrual bleeding, which is expected during first 6
months of injection use.
•
Medicines are available for heavy bleeding
•
Amenorrhoea - Inform about advantages e.g. improvement in anaemia, can
be compared with lactational / post partum amenorrhoea, no medication is
required, assure that woman is not pregnant and regular menstrual flow is
not necessary for good health.
Trainingfor Injection:
Aseptic conditions
Site of injection, no massage/ fomentation since this will reduce the efficacy
of the injection.
Disposable syringes and needles
Storage of drug / ampoules
When to initiate
Grace period/flexibility of subsequent injections
23
’ ri nj-fes a
Health care providers need to become skilled at counselling and disseminating
information, effective communication at each follow-up visit of the client taking
into consideration cultural differences. Women considering injectable
contraceptive, need to understand that her menstrual bleeding pattern may
change and the precise changes she may experience cannot be predicted, however
they are transient and reversible.
The rationale for the management of menstrual irregularities is as follows:
•
Rebuilding endometrium with estrogen/ combined oral contraceptive pills.
•
Non-Steroidal Anti-inflammatory Drugs (NSAIDs), which block prostaglandin
synthesis and decrease uterine bleeding temporarily.
Counseling women for contraceptive assists in having the full and correct
information of all available methods and selecting an appropriate method. Proper
counselling strongly influences long-term continuation rates of the contraceptive
as seen in Chinese study (pl. see figure on page 9).
General Considerations in Counseling:
In describing the balance between benefits and risks with use of injectable
contraceptive, it is helpful to individualize both sides of equation for each woman.
Prepare the client for likely side effects and let her know that there are ways to
minimize these side effects. It is equally important to explore women's attitudes,
myths and fears towards any particular side effect.
Management Options for Bleeding Irregularities induced by Injectable
Contraceptive:
Several research studies have been undertaken to understand the causes of
pienstrual bleeding irregularities induced by long acting progestin only
contraceptives. The exact cause and treatment is not yet understood. The various
management options are based on clinical experiences of the providers. The
counseling and education of clients are the mainstay of management and certainly
influence continuation rates.
. war ci sa' ••
24
0"
Management of Spotting or Slight Bleeding:
This is lesser than regular menses and it does not affect health even if prolonged
for sometime. Counseling and reassurance is needed. A pelvic examination to
rule out other causes of bleeding will further reassure the woman.
Management of Prolonged/Heavy Bleeding:
If a woman has bleeding more than twice as long as her normal menstruation, she
should be assured that this is normal and expected in some of' the women in the
first 6 months of injection use. Bleeding episode becomes shorter over a period of
time even with continued injection use.
Supportive treatment and counseling of the woman is required and assurance that
this bleeding is not a sign of disease. Iron and calcium supplements including
styptic drugs should be prescribed (please see flowchart on page 26).
C 'mseling ar-d
•
nc*' i.- ?
Management ofAmenorrhoea:
By 12 months of use of injectable, many women will experience amenorrhoea. This
is the most common' reason for discontinuation. If woman is concerned about
amenorrhoea she can be counseled about the advantages e.g. improvement in
anemia and can be compared with lactational amenorrhoea. There are no harmful
effects of amenorrhoea induced by injec cable contraceptive and regular menstrual
flow is not required for good health. If woman is worried, assure her about the
pregnancy and it should be ruled out by doing pregnancy test. Avoid use of
hormones to induce withdrawal bleeding Advise woman to wait for return of
menstruation.
The flowchart on page 26 states the various options for management of irregular
menstrual bleeding.
■
•
■
.
•
.
■
ni.
25
Approach to Treatment of Irregular Bleeding induced by
Injectable-Contraceptive
Injection NET- EN
Spotting bleeding
8-10 days or
No bleeding
irregularity
Woman requests
treatment
> Clinical evaluation
attne
Bleeding attributed to
Injection NET-EN
Other causes
investigate & treat
Tab. Mefenamic acid
500 mg bd or tds x 3 days
i
No Response
Combined oral pills preferably containing
0.05 mg EE 1 tab/day x 14-21 days
Bleeding stops
Bleeding continues
0.05 mg EE 1
tab/day x 10 days
........
.. T
V •' No Respc
...... —r •
-
•
■■
■
Bleeding stops
continue NET-EN
Note : While giving treatment woman
should be monitored by doctor
No response
Woman unhappy
discontinue inj. NET- EN
26
x IO.
Thus a 233 women participants requested to provide them medicines for frequent
bleeding. They were given drugs as shown in the following table.
All these women required to take medicines at subsequent follow up visits. This
treatment helped women in stopping/ reducing bleeding episodes temporarily
and further continuation of injections.
Drugs given for irregular/frequent
menstrual bleeding (n = 233)
Sr.
No.
Drug Particulars
1
Mefenamic acid
r—
....
. . .
No. of
subjects
Frequency
65
79 times
—
2
Styptic
92
111 times
3
Styptic and
Antiprostaglandin
24 .
31 times
4
Combined Oral Pills
52
63 times
i
, S U »'J jj ■ t
acKj
J
27
••
Acceptability and Continuation rates of 2 monthly Injectable
contraceptive Norethisterone Enanthate
Informationfor the participants
(If the woman is illiterate, the investigator should read this information to the woman)
Injectable contraceptives are safe, effective family planning methods that protect
women from unwanted pregnancies. All over the world about 14 million women
use progestin only injectable contraceptive. In India two types of injectable
contraceptives are available, one of which is administered every 2 months. This is
piarketed as Injection Noristerat.
The idea of offering this injection is to increase the choice of family planning
methods. If you select this method for family planning, we would collect some
information from you like your acceptance and views regarding this method.
Please read the following information about this injection.
How does this injection prevents pregnancy?
• It stops release of eggs from the ovaries.
• It also causes thickening of cervical secretions/fluids at the entrance of womb
making it difficult for the sperm to pass through.
Who can use this method?
• It can be used by women of any age or parity who want to space births.
• It provides effective and safe contraception after delivery and abortion.
• It is suitable for nursing mothers since it does not have effect on quality and
quantity of milk.
• Suitable for women who may have side effects related to use of oestrogen
containing contraceptive eg. Oral pills.
• Women with certain medical diseases, who can not use other contraceptives
eg. Combination oral pills, can use injectable contraceptive.
When is the first injection given?
• the first injection can be given anytime provided you are not pregnant,
preferably during first 7 days of your normal menses.
• Immediately after an abortion.
• 6 weeks after delivery if you are breast feeding.
What are the benefits of using this injection?
• It is very effective (99.6%) and reversible.
• It is a convenient method and will ensure/maintain privacy.
28
■
■.
i: ing SrU?‘7 d
Once you take this injection, you will be carefree about contraception for 2
months. You will not need to take every day like for the pills.
• In some women it may reduce painful periods.
• The regular visits for injection offer an additional advantage of regular medical
check up.
•
What are the likely disadvantages with this method?
• You may experience irregular periods like • spotting, delayed menses,
prolonged bleeding and rarely heavy bleeding.
• You may gain weight.
• You may experience headache.
• Once you take this injection, the effect will last for 2 months.
• If you wish to plan pregnancy you may conceive within 12 months after
stopping injection (i.e. 4 to 9 months after the effect of the last injection).
What you need to do if you take this method?
• You will be given choice of all the contraceptive methods available and will
have choice for yourself.
• If you choose this method you will have to undergo general and gynecological
examination.
• You can choose to take this injection either in the buttock or arm.
• You have to visit the centre for repeat injection aft^r 2 months.
• You will be given a diary card and explained to enter information on
bleeding/menses, ^ou have to bring this card at repeat visits to show us.
• We will offer this method for the duration of 2 years. You may decide to stop
this method any time you wish.
What happens if I have any problem?
• it you have concerns or questions about this injection, please come to the
centre. You may contact clinic doctor (
) or any
other staff at this address.
r
Telephone No.
Please Note:
•
•
•
Injectable contraceptive does not provide protection against HIV/ AIDS.
Treatment for any side effects due to this injection will be given at the
centre free of cost
Only health providers at the centre will have access to your records. Your
name or identity will not be revealed in any data reports.
: v 'cv..... ■
;
29
r
Acceptability and Continuation Rates of 2 Monthly Injectable
Contraceptive - Norethisterone Enanthate
INFORMED CONSENT
I
(full name) have been
made to understand that Institute for Research in Reproduction conducts clinical
trials of various contraceptive methods I have been fully inforfned about the aim
of this study. I have been explained all the advantages and disadvantages
including menstrual irregularities that can occur with the use of injectable
contraceptive method. I have been also informed about the benefits and risks of
other spacing methods like Cu-T 200, oral pills and condoms available in the
National family planning programme. I have selected 2 monthly injectable method
Noristerat willingly for spacing children. I have had all my questions and doubts
about this method answered and clarified.
INz Olx/s'j.'iJ’ LONS-LNJ.
. ,
I am willing to undergo physical examination, come for follow-up. I am also
aware of my right to withdraw from this study at any time without having to give
any reason for doing so, without loss of benefits or.utilizing the services of the
clinic. I will not have to pay for the injections.
-
Signature / thumb impression of acceptor
■
i.? i'
hod. answered ^nd-clai'jjuo.
Date:
go
• hy right
win jhis sludy « ■
Doctor's Name & Signature
30
Protocol Amendment - DEXA Study
Background Information:
Some recent reports from United States have shown that the bone mineral density
(BMD) decreased in adolescent women aged 14 to 18 years who used the 3
monthly injectable contraceptive-Depot medroxyprogesterone acetate (DMPA).
The decrease in BMD is dependent upon the duration of use, being maximum in
first one to two years. However, after stopping the injection, BMD increased (Arch
Pediatr Adolesc Med. 159(2): 139-44, 2005). It is not yet known whether bone loss
due to use of DMPA leads to osteoporosis and risk of fractures in later life. A
recent study carried out in Africa (March 2005), in women using injection DMPA,
iSFet-En, Oral pills and non-users were n ported to have no effect on BMD.
In November 2004, Pfizer company manufacturer of injection DMPA in agreement
with the United States Food and Drug Administration (USFDA) issued revised
labeling on the use of DMPA on BMD (Black Box warning). The warning suggests
that the use of injection DMPA causes a significant loss in BMD which is greater
with increasing duration of drug. Therefore injection DMPA should be used as a
long- term birth control method (more than two years) only if other birth control
methods are inadequate/ unacceptable. In this case, women should be evaluated
while taking the drug long term. However, currently World Health Organization
(WHO) recommends that women of 18-45 years of age can use DMPA and Net-En,
if they are eligible (WHO Category 1, Medical Eligibility Criteria for Contraceptive
Use, 2005).
<
The issue about DMPA use and decrease in BMD was raised by "All India
Democratic Women's Association" (May 2005). In view of this, an urgent meeting
of the Institute's Ethics Committee (IEC) was held on 17th May 2005. The ethics
committee discussed all these issues and available literature reports on BMD,
which mainly reported on injection DMPA. The committee also emphasized that
the duration of
Net-En Ouse oinf the Jongoing study
is for 2 years. The committee
. "
J
approved the following plan of action and the amendment was made as follows:
•
The additional parameter of DEXA for assessing bone density be carried out
as soon as possible in all the women who are still using injection Net-En.
•
The DEXA investigation will be repeated every six months during injection
Net-En use and one year after stopping the injection.
31
(aJH
■
•
-
• fori
’M0
•
These amendments will be for all the participants at all the centers, where
DEXA can be done locally.
Though, the baseline levels of the BMD in these women (prior to initiation of
injection Net-En) are not available, this will reassure the women about their bone
density status. DEXA will not be done for women who are planning to be
pregnant.
Before doing DEXA, pregnancy will be excluded, if necessary.
Accordingly the participant information sheet and consent forms were amended
and women were requested to re-consent for the additional DEXA investigation
during further participation.
Study Findings:
Following IEC approval and protocol amendment, the study was initiated at 6
centres where DEXA'facility was locally available. Three participating centres viz.
Nagpur and Cuttack were, excluded for DEXA study because of unavailability of
the DEXA machine in these cities. The centre at Kplkatta could not participate
because they had very few active women using injection. A total of 142 active
users of injection Net-En underwent initial DEXA scan,. The use of injection varied
between 14 to 22 months (DEXA-1). Of these, 73 eligible women still using
injection Net-En underwent repeat DEXA at 6 months interval (DEXA-2, Net-En
use 20 to 30 months). The final DEXA scans were done one year after stopping the
injection (n=109).
The observations showed that there was increase in mean BMD at both femoral
neck and lumbar spine; between first and second DEXA scans (Fig.l ). It was
observed that after taking more injections there was no decrease in mean BMD
The relative increase in mean BMD was also observed among women who
underwent DEXA scans 1 year after discontinuing injection, compared to the BMD
during injection use. There was positive correlation between BMD and Body Mass
Index (BMI). These observations are reassuring (Fig.2).
Since the baseline values (before initiation of injection) of BMD could not be
assessed in these women, it was necessary to compare BMD with those who did
not use any hormonal contraceptives in the past. Therefore, it was proposed to
enroll 59 healthy women matched with respect to age and parity with those of
injection users comprised the control group. An IEC approval was obtained in
November 2007. The participants for control group were selected from the
.
. ,
.
...
..
.
■
<:mt:
...
" r.:..;, h C. ..
32
•.
-
.
■
,
OiT'h'hHI -
Institute's family welfare clinics who did not use any hormonal contraceptive
methods in the past five years preceding DEXA scan. Lactating women were
excluded from the study. A written informed consent was obtained before taking
DEXA scan. The women planning pregnancy were excluded from the study.
Observations:
■
The mean BMD of women in the control group was compared with mean BMD of
73 women who had DEXA scan done while using injection (injection use 20 to 30
months). The findings showed that tKre was no significant difference in mean
BMD between control group and injection users (Fig.3).
Salient Observations of DEXA Study:
There was no correlation between duration of injection use and mean BMD. There
was positive correlation between BMI and BMD. Women with BMI of 25 and
above had significant. (pcQ.OOl) higher BMD, at both the sites compared to women
having low BMI of less than 20. There was inverse correlation between parity and
BMD. Mean BMD was significantly higher (0.886gm/cm2 P<0.05 ) among women
having 1 or 2 children compared with women having 3 or more children
(0.769gm/cm^). There was no significant difference in mean BMD among
• •
■ d Df.,. . ,
,
6
injection users compared with control group.
Conclusion of the Study:
The study findings showed that the skilled counseling and quality of services at
every stage of injection use, presence of medical doctor to look into the
problems/side effects induced by the injectable contraceptive, training of nurses
for injection technique, arid safe injection practices are necessary. There were inter
centre variations with regard to continuation rates of injection. The educational
status of the women did not have impact on 1 year continuation rate of the
injection Th^e was.no decrease in mean BMD observed among injection users
compared with control group. Comprehensive training of health care providers
pertaining to injectable contraceptive is necessary. Training
workshops/ role-play is more effective e i observed during the stiidy.
through
The findings of this study will be useful i
m programme implementation of the
injectable contraceptive.
j
:
...........
33
d 'Ie.‘I'K1-
' ' *'■
•■-d .■
\\ .....
'
' i,ljrr; .t, . C1'Il'ticeS .:
d io cpm;
........ , .
1
Acknowledgement
Dr. D Balaiah, Dr. Kamal Hazari "
Dr. Lalita Saverdekar,
NIRRH, Mumbai
[
Dr. V Salvi, Dr. K Mathur
HRRC (ICMR), Mumbai
Dr. H Saini, Dr. J Kashyap
HRRC (ICMR), Baroda
Dr. D. Kalavalli, Dr. Christe
HRRC (ICMR), Chennai
Dr. J J Mallick, Dr. S Nayak
HRRC (ICMR), Cuttack
Dr.ABhargava,Dr.MGupta
Dr. T K Ghosh, Dr. A Chanda
HRRC (ICMR), Jaipur
Dr. C Doifode, Dr. C Sarodey
HRRC (ICMR)f Nagpur
Dr. S. Salhan, Dr. H Gaikwad
HRRC (ICMR), New Delhi
Counselors, NIRRH Mumbai
Nurses - FP Clinics, NIRRH
Mrs. Neha Minde
Mrs. Chitra Thosar
Mrs. Pratibha Kokate h
Mrs. Dipika Belekar
Mrs. Shahni Baji
Mrs. Vidya Shenoi
Mrs. Rachana Dalvi
Mrs. Sunita Unde
Ruhi Pednekar
HRRC (ICMR), Kolkata
—
Data Management and Statistical Analysis
Mr. Prashant Tapase, Mr. R Parida
Project Staff: Data Entry Operators
Mr. Abhay Khanvilkar, Mr. Atish Chandorkar
Mrs. Kranti Patankar, Mrs. Seema Nare
- -
Social Staff: Ms. Dyaneshwari Sonawane, Ms. Rashmi Ingole
—
General Assistance: DCR, NIRRH
Mr. Anand Hankare, Mrs. Akshaya Rathod
.vMr: Ptisbaii? Tapasc Mi
34
References:
1.
IRR Annual Report 1975.
2.
World Health Organization, Task Force on Long Acting Systemic Agents for
the Regulation of Fertility. Contraception 15 : 513,1977.
3.
WHO Task Force on Long Acting Agents for the Regulation of Fertility. A
final report. Contraception 28 :1-20,1983.
4.
Indian Council of Medical Research, Task Force on Hormonal Contraception.
Contraception 30 : 561,1984.
5.
A Multicentred Phase III Comparative Clinical Trial of Depot Medroxy
progesterone Acetate Given Three Monthly at Doses of lOOmg or 150mg.
Contraception 34 : 223,1986.
6.
Belsey et al.: The analysis of vaginal bleeding patterns induced by fertility
regulating methods. Contraception 34 : 253,1986.
7.
ICMR Task Force on hormonal contraception. Contraception 34 : 573,1986.
8.
ICMR Task Force on Hormonal Contraception. Contraception 42 :179,1990.
9.
New Era for Injectables. Population Reports. Series K (5): March 1996.
10.
Lei Z-W et al.. Effect of pretreatment counselling on discontinuation rates in
Chinese women given Depo-Medroxy progesterone acetate for contraception.
Contraception 53 : 357,1996.
r
H/cJ.
' ••
. \• (. * ‘ ♦
J Avt-lCi I. (J
/ ■ k,
;
I ■
"
f j j
’ ■, ’
■, ’ , 'i ; t.
■
11.
Family Planning Methods - New Guidance. Population Reports Series 1
(44): August, 1998.
12.
The long acting progestin-only contraceptive injections An update. British J.
of obst. and Gynec. 108:3-8, 2001
13.
Scholes D et al. Change in bone mineral density among adolescent women
using and discontinuing depot medroxyprogesterone acetate contraception.
Arch pediatr. Adolesc Med. 159 (2): 139-44, 2005.
35
14.
Beksinska M E et al. Bone mineral density in women aged 40-49 years using
depot- medroxyprogesterone acetate, norethisterone enanthate or combined
oral contraceptives for contraception. Contraception 71(3): 170-5, 2005
15.
National family planning health survey 3,2005-2006.
16.
Position Paper. Depot Medroxyprogesterone Acetate and Bone Mineral
Density in Adolescents- The Black Box Warning: A Position Paper of the
Society for Adolescent Medicine. Journal of Adolescent Health. 39: 296-301,
2006.
17.
Expanding Services for Injectables. Population Reports. Series K, Number 6,
Jan- Feb 2007.
18.
Injectable Contraceptives: Tools for Providers. INFO REPORTS. Supplement
of Population Reports. Series K, Number 6, Jan- Feb 2007.
7 - Ji.m ■
■ perl• D^’jjot Medro'
■
36
List of Figures & Tables
Fig-l
Worldwide use of injectable contraceptive
Fig-2
Number of eligible women screened & enrolled for Net-En
Fig-3
Flowchart recruitment
Table 1
Eligible women - reasons for not accepting injection
Table 2
Socio demographic profile of the participants
Fig. 4a
Education of the participants
Fig- 4b
Family income per month of the participants
Fig. 4c
Religion of participants
Fig. 5a & b
Contraceptive methods used prior to participation in the
study
Fig-6
Number of injections - during a 2 year study period
Fig-7
Cumulative continuation rates of Net-En
Table 3
Table 4
Centerwise cumulative continuation rates of injection Net-En.
§pciu demographic profile of:: ic ••<...
Cumulative continuation rates of Net-En Vs. education
status of the participants
Table 5
Reasons for discontinuations of Net-En
Fig. 8
Percentage of different menstrual patterns
Fig. 9a
Change in body weight among NET-EN users during 1
year of injection use (n=709)
Fig. 9b
Change in body weight among NET-EN users during 2
years of injection use (n=417)
Fig.10
Overall effect on general well being
Table 6
Pap smear changes of Net-En users
Fig. 11
Haemoglobin status, of Net-En users
'I•
37
-ir1 ipi-x .use. (u ■ 7 09)
ClTangk ii't .
>
’h
Table 7
Questionnaire: Women's attitudes/ perceptions towards
injectable contraceptive
Fig. 12a
Knowledge about injectable contraceptive
Fig. 12b
Sources of information
Fig. 13
How did you remember dates of injection
Fig. 14
Should injection be available through NFWP
Fig. 15
Would you recommend this method to your friends and
relatives
Fig. 16
How much would you be able to pay for each injection
Hg-17
How long would you like to take injection
Fig-1
BMD values by DEVA among Net-En users '(n=73)
Fig-2
BMD values by DEXA among injection Net-En users
compared with injection discontinuers (n=109)
Fig-3
BMD values by DEXA among injection Net-En users
compared with Control (n=59)
Fig.4a & b
Bone Mass Density at Lumbar Spine & Femoral Neck
compared with Body Mass Index (n=142)
H^Abn’g wot;Id you ; ■*.<•
sQmpa?./! \
Bone M.yv \ h
c ohrpa i c ci \ i ih
l..O
Lvj ivxass iijGcx
■
38
Fig. 1: Worldwide use of injectable
contraceptive
45 n
40
rr
;
32 millions
CO
35 = 30 E 25c
cn 20¥tn 15
Z) 10 5 —0
; c
o
12 rnil-'or
I-
'W-
-’-v
40 millions
_________
r
f■
■■■
■
fe;
If -'
to
3
B; 12 millions
?
1992
2005
2015
Most popular method in Sub Saharan Africa, 38% women use inj.
Source: Population Reports,
(Series K, no. 6, Jan-Feb 2007)
39
Fig. 2: Number of eligible women attended
& enrolled for Net-En
0.
?T O fI 500
e n rc
4
! • U..
w
M
B0 0
No. not accepted: 1143 (48.6%)
‘ v4 txt
268
C
200
•:r 1:
E
o
100
J
4
386
300
0)
I GO
400
ex?
SITotal screened : 2352
□ No. enrolled: 1209 (51.4%)
0
1E
□
z
■■So®
1
M umbai NIRRH
o
173
159
IS
380
133
.. .
II
-----
MumbaiKEM
120
B ■.
:■■■
N agpur
_________________________________________________________________
Baroda
500
42 5
I
40 0
314
300
20 0
269
1 50
120 116
100
100
1 26 109
1 13
“Tn
0
Jaipur
New Delhi
40
K o1ka ta
C u tta c k
Chennai
Fig. 3:
Recruitment
Process
S
Recruitment
FP Clinic / OPD
loices
of FP ________________
MU.
—
Inforr. at
-
_
Information and counseling
T
Lv'Oi i ling for I MJ
' '■ .. ‘• I.
wiiix i Screening for eligibility
J
CT ^-.TTWUL1.- -SSBav
Eligible
I
n
Detailed information
g _____________
to accept
____
_
•11
Not willing,reasons
________:_______ _ ______________
cjj
41
Not eligible
Table 1: Eligible women - reasons for not
accepting injection (n = 1143)
£-■
F.
Reasons
S1
------------- :----------------
_______________
ent visits for
Frequent visits for repeat injection
if . f t
Numbers
%
318
27.8
201
17.6
■ ijcn
Prefers IUCD
ride effect1me
Fear of side effects (menstrual irregularity & weight
gain)_________________________ _
198
17.4
Family members' objection
132
11.5
Scared of Injection prick
120
10.5
Prefers permanent method
59
5.2
Prefers Oral Pills / Condom
49
4.3
Likely to migrate
31
2.7
Regular contraception not required
20
1.7
New method
9
0.8
Fear of developing male characteristics
6
0.5
embers' ol-iec
Injection
ric
: rm ariei?'
f-
f
42
,j
:i -f ■■
;
4
-if-
Table 2: Socio demographic profile of
the participants (n=1209)
Parameters
Mean (+ SD)
■
■
Range
■
-/t
O
ge (years
Age (years)
24.97 (3.8)
19 - 40
arity ■
Parity
1.53 (0.7)
1
BMI(kg/m2)
20.54 (3.6)
13.6-38.7
(kc^m
i
i
-
C i a;
Other Characteristics
Number
Percent
Interval cases
518
42.8
Post Partum cases
438
36.2
Post MTP cases
253
20.9
43
Stfe
fill
Fig. 4a: Education of the participants
(n = 1209)
■-
.wife -
-
601
s
50
s
40
©
-x
I
55.0
'J
30
15.6 -
©
©
20
15.6
15.4
Higher
Secondary
Graduate, post
graduate
»■
10
0
-1
4.2
lil
Primaiy
Secondary
■EBi
Illiterate
44
s
s
Fig. 4b
Family income per month of the
participants (n=1209)
56.7
60 n
50 -
C
<D
E
o
c
0)
o
CD
0.
5.5’
Illi
40 -
30
-■
21.8
20
10 -
I
21.8
Illi
7v ; .1
12.9
I
5.5
3.1
I
0
<1000
1000-3000
3001-5000
Rupees
45
5001-10000
>10000
Fig. 4c: Religion of the participants
(n=1209)
<-w
i a■
82.8
901
"7'W
80
70
60
i
I
I
■I
W-V-
IlliSI
liiliii
-
o
O 50
CD
I
40
30
20
10
0
1
11
J
|
'.7.-
Hindu
3.6
7^............
ta
~
Muslim
0.5
Boudh
46
0.4
■
Christian
Jain
Sikh
Fig. 5a: Contraceptive use prior to
participation in this study (n=1209)
. a
’ r
it
■
New acceptors
(n=488)
!
■
1ii*
'O-
..7
Oit
EteiiSfe
—____
___ ________________________________________________
Past users
40.36%
59.64%
3®t
J (n=721)
-J’sC
I
$
Fig:
Fig.5b: Contraceptives used (n=721)
‘■^4-
IU C D
34.3
••
• C=o n d o mVS p e rm ic id a l
5
Oral pills
fc
Inje eta b le /N o rp la rut
h
Withdraws I / N F P
s
•.. .. -
3 1 .8
25.9
4.3
3.5
Sterilization failure
0.3
0
5
10
47
15
20
25
30
35
Fig. 6: Number of injections received by
the women during a 2 year
tip'1
study period
1400
1200
fi
1 s
©
d
1000
800
i||i Illi
600
400
lolj
200 j|
o -F
1
»
i-
J_
Si itiil
2
3
4
5
6
7
8
No. of Injections
48
9
10 11 12
CM
§
co
co
CM
?c> II11in
I
W’
w
■
00
~
5CJ =5
eo °</)
CZ)
ES
O
*3 >C
CM
$
=3
.§ o~
g
c
o»
1
3
c c
o CD
o
■
J
■'
fi
1
<w
CD E
£
s§
Q
i
4
£i
1
co
'!
/
o
:
i
i
j
p
o
i
r
8 8 $ § 8
• «
■W<
o
u^woM juaouad
■
,
. .'. - Sajw'
Q
, '‘WfflBfjJ’
wW
fji ';
?
I
Z
o
i
1
6. Im
Table 3: Centre wise cumulative continuation
rates of injection Net-En
a
nr r ;
___________________
■
t
n: p- !
'6 me
r
■
j _ _____
-
Net-En use in months
u---e4n irornhs
p
■
Centers
W
6 months
*■' -fen'
s 12 months s
18 months
24 months
34.16
28.33
44.56
41.68
61.63
I
47.5
I
68.33
75.99
89.32
56.05
66.7 Cuttack
66.78
47.39 ,
37.7
54.48
33.39
r Jaipur
82.00
65.12
46.12
40.02
68.83
45.55
35.42
31.38
67.44
46.51
34.88
32.55
57.75
50.43
43.11
KEM Hospital
71.58
59.82
49.45
42.5
Nagpur
91.00
54.85
84.45
56.7
53.66
New Delhi
67.94
51.66
48.5
41.88
Baroda
B75 $ Kolkata
'-J .
Chennai
i -
NIRRH, Mumbai
Three FP Clinics
74.14
50
i
1
Table 4: Cumulative continuation rates of Net-En
Vs education status of the participants
(n=1209)
Education pl ' ftatusi
5
L ;
i
HV
6 mths
'12 ■ mths
i
■ ? T ’
|
%
7n
/O ‘
%
%
■ .
18 mths
24 mths
°/zo
%
46.11
40.1
f
75.54 40 55.96
Illiterate (n=115)
, Ji
==121'
i■
70.30 51
61.14
48.17
39.83
Secondary (n=595)
77.28
60.59
48.75 ’
43.91
Higher Secondary (n=189)
71.95
55.50
42.76
36.65
Graduate & above (n=189)
71.53
54.02
39.33
35.16
Primary (n=121)
-
—____ _
!=( \
VV- A - %
.
<
\\
51
1
/
mi -
ihtinua-. Si
Table 5: Reasons for discontinuations of
S
Net-En (women enrolled -1209)
t
Reasons for
discontinuation
6 mths I 12 mths 18 mths
%
o/o £;
%c
I
ii
y;
jht
_________
Menstrual disruption
& weight gain
8.4
Pregnancy
0.16
_______ -
______________________
i
24 mths Total
!
/0
%
2?
4 2
2.2
0.4
15.3
'
0.0!
0.08
0.0
0.24
■
i
zing nub-: i
Awaiting tubal
ligation
1.6
■c Q
1.9 5
1.5
0.9
5.9
iffnedfc al
rts
*Other medical
reasons
1.9
0
1.1
0.33
0.66
3.9
ns
Personal reasons
6.2
5.1
4.8
1.9
18.0
Lost to follow up/
Migration
10.9
2.9
2.2
0.7
16.7
TB, Hepatits A, Skin allergy, Headache, Accidental deaths, Malaria
52
Fig.8: Percentage of different Menstrual Pattern
in a two year study period
(Total Reference Period - 5666)
60 -1
52.3
53.1
50 =
it
it
8a>
a.
I
S.2
jA-
30 -
|
50.5
c\
8.1
■
27.2
■^r K
20.4
0 4
11
s§_
6 mths
■ Frequent
>-
44.6
■
37.7
30.4
tF-'
I
■
5.0
11
4.8
I
i a B
IS
-J
-1
I
i
^30.4
eq
20 10-
S
- .isiis... - -
40 -
•
I
■1..
53.2
12 mths
S Infrequent
■ Normal
18 mths
24 mths
□ Amenorrhea
WHO guidelines (Belsey et al., 1986),
Frequent Bleeding - More than 4 bleeding/spotting episodes during the ref. period
Infrequent Bleeding-1- 2 bleeding or spotting episodes
Regular Pattern -3-4 episodes of bleeding or spotting each lasting about 5-7 days
Amenorrhea - No bleeding / spotting days during the reference period
53
Fig. 9a: Change in body weight among Net-En
users during 1 year of injection use (n=709)
70
60
OAfter 1 year, of ini. use
9’31 8.97
El P re in jectio n
8.71
8.69
8.72 9.03
7.35
50
ch
£
g>.
I
40
8.8
6.0
5
5
i
30
■■
5
20
J
10
y
0
Total(n = 709)
No change In weight Weight lose (n = 113) Weight gain (n = 446)
(n=150)
Fig. 9b: Change in body weight of Net-En
users during 2 year of injection use (n=417)
70
EJ After 24 month of Imection use
60
T
50 -j
1
40 -
ffliaii
i pi 12 i|| d 1
9.4
I I
I
‘
7.61
)
H
S
30
t
‘I
>. ;
t 1
20
10
• •:
1
H
H
0
, L___
Total (n=417)
i:
r-
■
i
r
’
!|
JU
No change in weight
54
Weight loss (n=49)
-1
' I
I
I 1
’
1
I
Weight gain (n=319)
.10: Overall effect on general well being/
health (n=539/968)
44.32
r
t
o
: Y"'
7 ■ Bh^"
a: 7..
'
Jfif.
Weightgain
i
t3elh>r
Ivl
18.9
bloatedness
'blG^tec’-ne
krert bl;
20.6
Lethargy
.7 ’€.• •
’•
Irretabjlity
15.2
g>w i,-i.. i.......
Mood changes
_ 13.7
'
6.5
Backache/leg pain
3.5
breast tenderness
r
0
T
5
55
10
15
20
2
Table 6: Cervical cytology (Pap smear)
during injection Net-En use
(n=550)
A
e
...
11
Admission/
.fl P'b:,'
N©'
:nfi
sn.fi
Jer
Number
Percentage
382
69.45
64
11.64
Negative
59
10.73
Inflammatory
43
7.82
Inflammatory
CIN I
1
0.18
Negative
CIN I
1
0.18
Post injection
B Pre-injection Pap Pap (1 or 2 yrs.)
; q Q Negative
j .
£ /j a
fim
38: Negative
Inflammatory
6^ Inflammatory
Inflammatory
CO
f s' -’5? rr Negative
56
<
-
_________
-
ft
w■
Fig. 11: Haemoglobin status of Net-En users
before and after 1 or 2 years of injection
14 3
0 Pre injection
H After 1 or 2 years of Injection use
11
xO
E
W
U) 8
10.15 J
10.55'
i
6
I 'I
4
i I
■■
n
jJ j
10.28!
0
fti.il
t 1 30.23
10.7'
i
■
iio.oo.
' 10.2
i 5
F'
____
Total (n=229)
I
'
II
!
,
■
J
i
IL1
No change in Hb
(n=61)
57
i
9?? ■'
II I
■
2
I I
3
■
’■
o 4
I
FT
° 10
I '
I
I I
? :
3 I
L_
Increased Hb
(n=130)
I
1
I 1
■
I
Decreased Hb
(n=38)
Table 7: Women's attitudes/perceptions towards injectable contraceptive (n-968)
Questions
.
1. Did you know injectable
contraceptive prior to this study?
if yes - sources (n=1209)
;
Responses
Yes
No
%
486
723
40.2
59.8
578
193
197
59.7
19.9
20.4
■_______________________________________________ ___
--tismeAod?
2. How did you fine
Number
—Satisfied
Wery satisfied
Not satisfied
3. Was it convenient for you to
take injection?
Yes
No
857
111
88.5
11.5
4. Would you like to take injection
every 2 months or 3 months?
2 months
3 months
Can not say
575
291
102
59.4
30.1
10.5
495
343
123
7
51.1
35.4
12.7
0.7
870
98
89.9
10.1
IV* >.
5. How did you remember the
dates of these injections?
CC' i
nor U) this stud v?
-j.
ln-i;2G9)
’**• ‘
.,
1
"'
'r.Hj
■
'
■ -
i
’
: Jl.
_________
_
'
Written on menstrual card
I could memorize
Reminded by clinic staff
Husband reminded
6-
menstrual periods?
' •" V e.ryftja usnr.i.i
7. Was it acceptable to you and
. your spouse?
Yes
Neither
644
226
74.0
26.0
8. Change in sexual behavior
during injection use
Yes
No.
113
855
11.7
88.3
9. Did this method interfere with
your social/routine activities?
Yes
204
764
21.1
78.9
10. Do you think this*injection
should be available an NFWP?
’VYesfe '
864
54
50
89.3
5.6
5.2
435
50.2
220
25.4
151
36
18
4
17.4
4.2
2.1
0.5
No
No l .
No opinion
10 a. If yes? Why?
. . .e-ure - . n jeln ■
Convenient, ho daily intake
like pills
Everyone can afford and
access through NFWP
Wider choices of FP methods
Non coital dependent '
No effect on breast milk
No response
. ... :................................................... -
!
A'.-
'’•nr7 .
■
.
i .
'58'JO
Nooini j
4..'n
i . ’oi'M/enient... • no
■■ '‘Wife
Can
affc,
' I
b
• :
• yW'— ■ ■ .
X
+ r.,
.
+.
Women's attitudes/perceptions towards injectable contraceptive ctd....
Responses
Questions
Number
%
11. Would you be able to pay for
injection?
Yes
No
Can not say
585
351
32
60.4
36.3
3.3
11 a. If yes, how much for each
injection?
Rs.10-25
Rs.26-50
Rs.51-75
Rs.76-100
More than Rs.100
100
284
39
103
59
17.1
48.5
6.7
17.6
10.1
Atl^astoneyear
More than two years
261
330
377
27.0
34.1
38.9
13: Would you recommend this
method to your friends/relatives?
Yes
No
No opinion
769
62
137
79.4
6.4
14.2
13 a. Reasons for recommending
Care free for two months, no
hassle like taking daily pills.
Better2dhan IUCD as it is
invasive procedure.
Nohlcoital dependent.
Effective method.
Suitable for breast-feeding
JJ^af^oru
be maintained.
Less pain during menses.
•No response.
502
65.3
132
17.2
27
41
32
3.5
5.3
4.2
16
4
15
2.1
0.5
2.0
726
242
75.0
25.0
^qr eat ii
■ L' :
all..
■ ll'e t.o take
r
14. User's
injectable
concerns/ fear
\
No concerns
Concerns
Effect on future fertility ,
quantity of breast milk, effect
on blood pressure, HIV
itransmission through
repeated needle pricks and
fear of; genital cancer_______
about
■
’
•N <
•
■
•■■■?'
rncthi''
■
■■
■
■■n-
■
r-
>me$.
ik’-lv.- tw ■ an n
59
’1
j . -tonsmtsitort fhapUs I:
I
"n?
'
■
Fig.12a: Did you know injectable contraceptive
prior to parti ci pa tion inifbis study (n =1209)
70 q
F
&K fS:
i Sr -»
#
“ 5
1|
'f
-i-
c
<D
E
o
5
c
0)
o
0)
Q.
n=723
60
5 01—
> e-'j
4 01-
vis< HF.
7 ft’
n=486
|
II
?
30 20 -
40.2%
1
10•-
__________
o-W—
Yes
Y sNo
®8
Fig. 1,2b: Sources of information (n =486)
<■
1
7
2b:
59.8
.
Ba54.8
Friends/relativesl
41.2
Health personnel
14.8
Private doctors
Media
0
10
20
30
Percent
40
Percentages do not add up to 100 due to multiple responses
60
50
60
a
Fig.13: How did you remember dates of
injection (n=968)
0.7%
12.7%
dates on menstrual card
□ by memory
alibi
as
51.1 %
!/
■
■
■’
■
■
/
□ reminded by clinic staff
□ husband reminded
■
■
Would you like to take injection every
2 or 3 months (n=968)
H 2 months
10.5%
□ 3 months
30.1%
59.4%
61
□ Cannot say
Fig. 14: Should injection be available
o
through NFWP (n=968)
if
1 0 0
7
.jggg
*- £?;’‘
c
a
6 0
I
f
■
'■
20
wr
#
wB < 2
■
4
.r
N o
N o
C o ri vte n ie n t,&i o
opinion
f?
--■
g _Q 2
.... ..... ••Xj-'™""’
daily intake like p ills
Everyone can afford and "access
-- -
2 5.4
Widerchoices of F P methods
Non Co ita I dependent
No effect on breast m ilk
No o p in io n
4 .2
f2'1
0
1 0
20
3 0
Percent
62
*■'
<
If yes, why (n=864)
I* fy
■
■■■A--
5 .2
5.6
Y. e s o p
-
^|r
W
ss
0
y Q -g v ;
- ■$'■
v 3;
4 0
2'^
1
i
8 0
8
■-If
8 9.3
40
50
60
Fig. 15: Would you recommend this method
to your friends and relatives (n=968)
5
E
o
■
-w
100
* S
§ ® 50
2
O.V
o
^2W.
a
e
79-4
-
.
■
i- II
6.4
Yes
No
I
No opinion
- -f
Num ber
Percent
502
65.3
132
27
41
17.2
Suitable for breast feeding women
32
4.2
Privacy can be maintained
16
Less pain during menses
4
No opinion
15
T otal
769
2.1
0.5
2.0
100
If Yes, Why?
t
~ i
Care free for two months ;
. OC.’JUD
14.2
Better than OCZ IUD
F
1
Non Coital dependent
j
Effective Method
I
63
3.5
5.3
Fig. 16: Affordability for injection (n=968)
i:
S Yes
-it-'
60.4%
••
.y
III
0 No
■
M...
L’-?V
-
36.3%
3.3'4-'
-■
§
f.
:
4
■ Cannot say
wI
3.3%-z
How much would you be able to pay for I
3G4
reach iniection
injection (n=585)
■X
48.5
50 n
-few
=
2
0)
D.
40
30
20
17.1
17.6
6.7
10
10.1
f
3
0
10-25
26-50
51-75
Rupees
64
76-100
>100
I
Fig. 17: How long would you like to
take this Injection (n=968)
s
M--'
i
44.5
50
38.9
4.
40
a>
E
o 30
c
1
^4
|
< n-
CD
O
o
CL
t
16.5
20
I®
10
0
xz^Ws|
<
;ili' _____
>2 yrs.
<1 yr.
65
Fig. 1: BMD values by DEXA among
Net-En users (n=73)
1
H Initial DEXA
0.95 0 At 6 mths interval
■ 6:- r
es
0.954
0.925
CM
U)
Q
0.9 -
i
ft 'Z.S ;
0.85 -
?c 0.8
lilil
0.832
u
s
'
ftiil
0.75
si
ill
Il ■
Lumbar Spine
Femoral Neck
66
Fig. 2: BMD values by DEXA among injection Net-En
users compared with injection Uf fOUM ffCfffU O
(n=109)
xv
t r*
1.000 n
CM
E
o
E
□)
Q
0.950
S Inj. Net-En users
0.969
B Inj. Net-En discontinuers
S
0.900
S
CD
c - 0.850 cn0
S
0.800
0.750
0.919
?!
W'
4: III
■■1
0.850
0.826
■
-r f . ---
/
.■ ’W
i igl
1-fe^
„ __________________
Femoral Neck
67
Lumbar Spine
,
c:
UJ
CD
E
o -s
os
*5 IQ
o II
CD C
o
o
O) 'Uu
c: ‘
o o
o
3
e
o
S-
■
!
1
•1
-
■
ji
ECB o
£
J
><UJ gs
Q
'
s
fi
GJ.
i 1g
«Q 2
Q.
§
OQ
■■
(0
=3
w
II ; ' I - 7
—<
.
i j i i iO
o
I
§
I~1
©
‘<V^ \
'
■' "
®
o
©
o
• M
c*)
O)
■
I AZ/KW^IS
j -
<D E
5 O'
■*; O
(XJ
Q O
oo
o
'
KA: *•.
o
o
■.
2uj3/iu6 ai/\|g ue3|/\]
Is . .
■'.'O
•
»
' GO ’ ’^'y
ft
■.
a.
o
90
O
s s
oo
^D
1 .4
CM
1 .2
E
1
E
0 .8
o
*«*.
D)
0
s
T
0 .4
S
0
0 .9 35
».,42
0.871
0 .6
CD
c
co
0)
Fig. 4a: Bone mass density at lumbar spine compared
with body mass index (n=142)
■■l
1
1
■
■
j
0 .2
JI
11
_
2 0
2 < 2 0
2 4
?
U4
2 5 and
above
Body Mass Index
Fig.4b: Bone mass density at femoral neck compared
? 1 .2
with body mass index
ffl' "eo
1
£
0 .8
D)
O
0 .6
§
0 .4
i
2
0 .2
0
0.897
1-7 . .
852
|o 7 7 31
■f':f
•1'
i»7
L
’fl
s
i
e-lQI
U.
2 0-24
<20
Body Mass Index
69
■
K
H
II
fl
2 5 and
above
L
J
- Media
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