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

NCT ID: NCT01702402

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6916 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2014-08-31

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

Conditions

Health Knowledge, Attitudes, Practice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Educational and Behavior Change intervention

Intervention Type: BEHAVIORAL

Integrate post-partum family planning education and counselling into 2nd Antenatal Home visit by CHW (at approximately 32 weeks of pregnancy) Integrate post-partum family planning education and counselling into post-partum visits by CHWs during first month Continue providing family planning education and counselling to women through CHW home visits after first month.

Promote discussion and acceptance of post-partum family planning methods among key household members.

Facility level Ensure availability of postpartum contraceptive methods such as progestin-only pill.

Ensure availability of post-partum family planning and post-natal services. Community level Increase community awareness of the importance of birth spacing and benefits of LAM Educate influential community members on the importance of birth spacing and benefits of LAM.

Comparison

A comparison area received standard government health services.

Group Type: OTHER

Comparison Group

Intervention Type: OTHER

A comparison area received standard government health services.

Interventions

Educational and Behavior Change intervention

Integrate post-partum family planning education and counselling into 2nd Antenatal Home visit by CHW (at approximately 32 weeks of pregnancy) Integrate post-partum family planning education and counselling into post-partum visits by CHWs during first month Continue providing family planning education and counselling to women through CHW home visits after first month.

Promote discussion and acceptance of post-partum family planning methods among key household members.

Facility level Ensure availability of postpartum contraceptive methods such as progestin-only pill.

Ensure availability of post-partum family planning and post-natal services. Community level Increase community awareness of the importance of birth spacing and benefits of LAM Educate influential community members on the importance of birth spacing and benefits of LAM.

Intervention Type: BEHAVIORAL

Comparison Group

A comparison area received standard government health services.

Intervention Type: OTHER

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

• Women not of reproductive age (unless they fall under other category)
• Infants- over age 1

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jhpiego

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

John Snow, Inc.

INDUSTRY

Sponsor Role: collaborator

Save the Children

OTHER

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: collaborator

Population Services International

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Abdullah Baqui

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdullah H Baqui, MBBSMHSDrPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

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.

Reference Type: DERIVED

PMID: 33287907 (View on PubMed)

Other Identifiers

GHS-A-00-08-00002-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

00000149

Identifier Type: -

Identifier Source: org_study_id