A pilot study to compare discontinuation, side-effects, cost-effectiveness and implementation challenges between 3rd and 2nd generation Oral Contraceptive Pill (OCP) in one upazilla in Bangladesh
- Conditions
- Oral contraceptionReproductive Health and Childbirth - Contraception
- Registration Number
- ACTRN12622001062718
- Lead Sponsor
- Ministry of Health and Family Welfare
- Brief Summary
This study was conducted to compare acceptability, side-effects and discontinuation rates between 2G- and 3G-OCPs. After checking for eligibility criteria, from each intervention and control area, 1400 married women of reproductive age were enrolled in the study by the health workers. Women in the intervention group were provided with 3G-OCP and those in the control group had 2G-OCP; 2 cycles at enrolment and 2 cycles at each of the 2 follow-up visits at home by the health workers. All the women in both the groups were interviewed three times: at enrollment and at two subsequent follow-up visits at home at 3-months apart by the study interviewers. Initially, the reported side-effects for 3G-OCP were higher than that by the 2G-OCP (47.3% vs. 33.2%); however, after 24-weeks of use the difference was eliminated (9.5% vs. 8.7%). After 24-weeks of use, 20.4% women from the intervention group and 19.5% from the control group discontinued the method due to pill use-related side-effects. Taking into account the duration of use, the cumulative discontinuation rate due to side-effects was 22.8% for 3G-OCP as compared to 25.2% for 2G-OCP though the difference was not statistically significant. After adjusting for other potential sociodemographic characteristics, the likelihood of discontinuation of 3G-OCP was 14%, lower than 2G-OCP which was statistically significant at 10% level.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 1400
i) married women within 15 and 39 years of age; ii) not pregnant at the time of enrollment; iii) no desire for having a baby in the next 1 year, and iv) willing to use OCP as a contraceptive method for the next 6 months.
i) lactating mothers with a less than or equal 6-months-old baby; ii) known case of hypertension; iii) BMI greater than or equal to 30; iv) migraine; v) blurring of vision; vi) varicose vein, and vii) known case of diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method