Clinical trial NCT01702402: Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh
Official title: Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh (Healthy Fertility Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Keywords: intervention
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Jhpiego
name: Johns Hopkins University
name: John Snow, Inc.
name: Save the Children
name: PATH
name: Population Services International
First posted: 2012-10-08
Enrollment: 6916
Sex: ALL
Minimum age (years): 1
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of enrolled women (15-49 yrs) using a contraceptive method at 3, 6, 12, 18, 24, 30 and 36 months
timeFrame: 5 years
Secondary outcomes:
measure: Probability of a subsequent birth within 24 months of index birth
timeFrame: 5 years
measure: Percentage of enrolled women with short birth intervals
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Abdullah H Baqui, MBBSMHSDrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stake S, Ahmed S, Tol W, Ahmed S, Begum N, Khanam R, Harrison M, Baqui AH. Prevalence, associated factors, and disclosure of intimate partner violence among mothers in rural Bangladesh. J Health Popul Nutr. 2020 Dec 7;39(1):14. doi: 10.1186/s41043-020-00223-w.