Department Of Clinical Research



 

 

 

 

 


A total of 1209 healthy women aged between 20-40 years, at least having one living child, desiring spacing method were enrolled across India .

The studies were designed with the objectives to:

i) Assess acceptability/continuation rates of two monthly injection - Norethisteron Enanthate (Net En)

ii) Evaluate the incidence of side effectslike menstrual irregularities and weight gain

iii) Study women’s attitude/perceptions towards injectable

iv) Study return of fertility following discontinuation of injection.

The injection was offered under the 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, 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.

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. Major reasons for discontinuation were due to personal reasons, lost to follow-up and migration because of floating population. Method related discontinuation like menstrual disruptions; weight gain and pregnancies were observed in 15.5% of women. The method was found to be very effective since there were only three pregnancies reported during the 2 years of injection use. About 89% women said that injections should be made available through the National Programme, since the method is more convenient compared with daily intake of oral pills, does not have effect on breast milk, offers a wider choice of Family Planning (FP) methods etc. Over 79% were satisfied with the use of this method and would recommend to their friends and relatives. About 39% requested to provide them further injections after completion of the study.

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.

The method was well accepted by majority of women, thus it can fulfil the unmet need for contraception. Based on these study findings, the Government of India has considered introducing injectables in the programme. The Phase I preparatory stage of this study is underway and is being coordinated by ICMR RHN division.

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). It is not yet known whether bone loss due to use of DMPA leads to osteoporosis and risk of fracture in later life.

In view of this, additional parameter of DEXA for assessing bone mass density among injection Net En users was studied. The DEXA findings revealed that 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 (p < 0.001) 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 (0.886 gm/cm 2 p < 0.05) among women having 1 or 2 children compared with women having 3 or more children (0.769 gm/cm 2). There was no significant difference in mean BMD among injection users compared with control group.


For more details, please refer to www.mohfw.nic.in/dofw website/Final_Net-En_Report.pdf