Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh

Not Applicable

Completed

• Conditions: Health Knowledge, Attitudes, Practice
• Interventions: Behavioral: Educational and Behavior Change intervention; Other: Comparison Group

• Registration Number: NCT01702402
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

The proposed operations research study is designed to evaluate a package of family planning services and related behavior change interventions aimed at addressing the unmet need for family planning in postpartum women, integrated with an ongoing maternal and newborn health program, and to assess the program's impact (1) on knowledge of healthy fertility practices, (2) on contraceptive use prevalence in women during the postpartum period, (3) on postpartum birth spacing, and (4) to examine the feasibility and sustainability of the proposed integrated service delivery approach. The study will have a quasi-experimental design, with evaluation primarily through household surveys in four intervention unions and four comparison unions (unions are lowest local government entities with an average population of about 20,000) in rural Sylhet District, Bangladesh.

Detailed Description

The specific objectives of this operations research are:

1. Integrated Family Planning/Maternal Neonatal Health Intervention: To develop and test an integrated Family Planning and Maternal and Neonatal Health (FP/MNH) service delivery approach in the Bangladesh setting, building on the ongoing Projahnmo study. Intervention activities will include behaviour change communications on healthy timing and spacing of pregnancy, couples counseling, social networking and expansion of contraceptive options for postpartum women, including provision of oral contraceptive pills and condoms in the home.

2. Integrated Service Delivery Approach: To assess the strengths and limitations of integrating family planning into an ongoing community-based maternal and newborn care program.

1. To compare the quality of counseling provided by CHWs in the integrated (MNH+FP) intervention arm versus regular (MNH) control arm in Sylhet district, Bangladesh

2. To assess the knowledge of CHWs providing integrated (MNH+FP) counseling in the intervention arm versus CHWs providing regular MNH counseling in the control arm in Sylhet district, Bangladesh

3. To determine factors that affect the quality of care provided by CHWs in both the intervention and control arms in Sylhet district, Bangladesh

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-08
• Primary Completion: 2013-09
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-12
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6916

Inclusion Criteria

• Unions have been selected by the following criteria: 1) currently implementing Projahnmo MNH program; 2) Similar demographics between intervention and comparison unions; 3) Input from local health officials regarding the most suitable Unions to work in; and 4) Capacity and demonstrated willingness of health workers at the Union level based in Union Health and Family Welfare Centers to collaborate with the project and work to achieve its objectives.

Recently delivered women Infants Community providers Husbands Mothers-in-law Community providers

Exclusion Criteria

• Unions not adhering to inclusion criteria.
• Women not of reproductive age (unless they fall under other category)
• Infants- over age 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Educational and Behavior Change intervention	Intervention activities will include behaviour change communications on healthy timing and spacing of pregnancy, couples counselling, social networking and expansion of contraceptive options for postpartum women, including provision of oral contraceptive pills and condoms in the home.
Comparison	Comparison Group	A comparison area received standard government health services.

Primary Outcome Measures

Name	Time	Method
Proportion of enrolled women (15-49 yrs) using a contraceptive method at 3, 6, 12, 18, 24, 30 and 36 months	5 years	Determine the impact of the maternal and neonatal health (MNH) intervention package on the contraceptive prevalence rate (CPR) among enrolled women (15-49 yrs) at 3, 6, 12, 18, 24, 30 and 36 months among the study sample. CPR is defined as the number of enrolled women using a contraceptive method divided by the total number of women enrolled at a point in time.

Secondary Outcome Measures

Name	Time	Method
Probability of a subsequent birth within 24 months of index birth	5 years	Probability of a subsequent birth within 24 months from the index birth assessed by the lifetable method in enrolled women (15-49 yrs) among the study sample.
Percentage of enrolled women with short birth intervals	5 years	Percentage of enrolled women (15-49 yrs) with short birth intervals (birth-interval \<24 months between the index child and any subsequent births) among the study sample.