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

This study has been completed.
Sponsor:
Collaborators:
Jhpiego
Johns Hopkins University
John Snow, Inc.
Save the Children
PATH
Population Services International
Information provided by (Responsible Party):
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01702402
First received: November 3, 2011
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Health Knowledge, Attitudes, Practice
Behavioral: Educational and Behavior Change intervention
Other: Comparison Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Operations Research to Address Unmet Need for Contraception in the Postpartum Period in Sylhet District, Bangladesh (Healthy Fertility Study)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Proportion of enrolled women (15-49 yrs) using a contraceptive method at 3, 6, 12, 18, 24, 30 and 36 months [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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:
  • Probability of a subsequent birth within 24 months of index birth [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 6916
Study Start Date: June 2007
Study Completion Date: August 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: 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.

Comparison
A comparison area received standard government health services.
Other: Comparison Group
A comparison area received standard government health services.

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

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702402

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Jhpiego
Johns Hopkins University
John Snow, Inc.
Save the Children
PATH
Population Services International
Investigators
Principal Investigator: Abdullah H Baqui, MBBSMHSDrPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Abdullah Baqui, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01702402     History of Changes
Other Study ID Numbers: 00000149, GHS-A-00-08-00002-00
Study First Received: November 3, 2011
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
intervention

ClinicalTrials.gov processed this record on October 30, 2014