NCT01702402

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,916

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2011

Completed
11 months until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

6.3 years

First QC Date

November 3, 2011

Last Update Submit

September 12, 2014

Conditions

Keywords

intervention

Outcome Measures

Primary Outcomes (1)

  • Proportion of enrolled women (15-49 yrs) using a contraceptive method at 3, 6, 12, 18, 24, 30 and 36 months

    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.

    5 years

Secondary Outcomes (2)

  • Probability of a subsequent birth within 24 months of index birth

    5 years

  • Percentage of enrolled women with short birth intervals

    5 years

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Comparison

OTHER

A comparison area received standard government health services.

Other: Comparison Group

Interventions

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 Arm

A comparison area received standard government health services.

Comparison

Eligibility Criteria

Age1 Minute - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Behavior

Study Officials

  • Abdullah H Baqui, MBBSMHSDrPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2011

First Posted

October 8, 2012

Study Start

June 1, 2007

Primary Completion

September 1, 2013

Study Completion

August 1, 2014

Last Updated

September 16, 2014

Record last verified: 2014-09