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
Ministry of Health and Family Welfare
1,400 participants
Oct 8, 2017
Interventional
Conditions
Summary
This study aimed i) to compare the discontinuation rate along with the reasons for discontinuation of 3rd and 2nd generation OCPs ii) to document the side-effect profile and satisfaction levels for the above two types of OCPs iii) to compare the level of compliances (correct and regular use) of each of the OCP type iv) to investigate the advantages and challenges related to the distribution of 2nd and 3rd generation OCPs among the clients v) to document the opinion of the policy makers and program personnel about the importance of introducing the 3rd generation OCP in the national program vi) to assess the cost effectiveness of 3rd generation OCP than the 2nd generation OCP. A community trial was conducted in 2 unions (one intervention and one control) of the Sarankhola upazila of Bagerhat district where OCP discontinuation rate was high (30%). The study employed both quantitative and qualitative research methods to address the objectives. Cost analysis was done for assessing the cost-effectiveness of the intervention. In each intervention and control area, 1400 eligible women were recruited after screening, checking for the selection criteria performed by the existing family planning field workers (FWAs/FWVs). 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 FWAs/FWVs. 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 for collecting detailed information on their OCP use related practices, side-effects, continuation status including the reasons for discontinuation when applicable. In addition, under the qualitative component, the study conducted 6 Focus Group Discussions (FGDs) with the clients who continued and those who discontinued the OCPs in this study for their perceived satisfaction and dissatisfaction with the type of OCPs they had used. A series of in-depth interviews of the family planning field workers and their supervisors; service providers; program managers and community leaders were also conducted for their perception on advantages and challenges related to distribution of 2nd and 3rd generation OCPs to the clients. The team also documented their opinion about the need of introducing the 3rd generation OCP in the national program.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- 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.
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Interventions
For the intervention area of this study, 3rd generation OCP (3G-OCP) was procured from a renowned pharmaceutical company, named, Renata Limited, Bangladesh, which was available in the market with the brand name ‘Desolon’. Each Desolon pill contains Desogestrel BP (0.15mg) and Ethinylestradiol BP (0.03mg). Each cycle of ‘Desolon’ comes in a strip with only 21 pills and does not contain iron tablets. To make the strip similar to the 2nd generation OCP (2G-OCP), the brand name of which is ‘Sukhi’ and is available in the National Family Planning Programme (NFPP), customization of the strips of ‘Desolon’ was done by Renata Limited by adding seven additional iron tablets (each containing Ferrus Fumerates BP 75.0 mg) for the current study. Specific administration methodology: a) Frequency of administration: one pill a day b) Duration of administration: a single 4-week cycle, 6 x 4 weeks back-to-back (24 weeks total) c) Route of administration: oral pill. d) Strategies used to monitor adherence to the intervention: drug tablet/ blank strip return, verbal confirmation of the participants at 3-month and 6-month follow-up interviews. Selection of intervention area and control area: The study was conducted in two unions (one intervention and one control) of the Sarankhola sub-district of the Bagerhat district of Bangladesh where OCP discontinuation rate was high (30% during January-December, 2016). From the 4 unions of the Sarankhola upazila, the intervention area (Khontakata union) and control area (Rayenda union) was pre-determined at the discretion of the principal investigator as the geographic accessibility in these two unions was better relatively as compared to the other two and also the number of OCP acceptors was close to the expected minimum number required for this study.
Locations(1)
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ACTRN12622001062718