Increase First-time Mothers' Use of Postpartum Family Planning in Bangladesh: The Connect Project (Connect BD)

Leveraging and Strengthening Local Systems to Increase First-time Mothers' Use of Postpartum Family Planning and Improve Postnatal Care in Bangladesh: A Cluster Randomized Controlled Trial

While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial.

Study Overview

• Status: Completed
• Conditions: Contraceptive Usage
• Intervention / Treatment: Behavioral: Connect

Detailed Description

While a growing body of programs have shown promise to increase uptake of contraception among FTMs, difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Despite the importance of PNC it remains a neglected area within the maternal and newborn health continuum of care in many areas around the world. Programs working to improve coverage of PNC and PNHVs have faced difficulties with insufficient human resources and health systems, suggesting a need for prioritization of care in settings with limited human resources. Connect's approach aims to strengthen existing government health systems and community-level health efforts, including those supported through local and international non-governmental organizations, by developing and testing light-touch "enhancements" with the goal of increasing PPFP and PNC uptake among FTMs. The investigators will evaluate Connect's approach through a cluster randomized control trial.

The overall goal of this study is to add to the evidence base on scalable and efficacious approaches for increasing PPFP adoption and improving timing and uptake of PNC among adolescent and young FTMs in order to increase spacing before subsequent births and improve maternal and neonatal outcomes.

Specifically, this protocol outlines the parameters for the evaluation of the impact of Connect's package of community-level interventions-or "enhancements"-on adoption and continued use of modern PPFP methods and uptake of PNC among adolescent (ages 15-19 years) and young (ages 20-24 years) FTMs. These interventions are enhanced home visits by family welfare assistants (FWA) and FWA-led enhanced courtyard meetings.

FWA enhanced home visits are targeted based on identification of at-risk mother-baby dyads through a risk-stratification algorithm to ensure home visits to all FTMs who give birth at home and to at-risk mothers, including first time mothers. FWAs performing the enhanced home visits have undergone additional training emphasizing the importance of referring mothers to facility-based providers, encouraging facility delivery, encouraging attendance of courtyard meetings, involving other family members during the visit, and on the specific needs of first-time parents. Invitation cards to go to the nearest facility and mother-baby booklets within formaiton on ANC, PNC, AND PPFP are also provided.

Enhanced courtyard meetings include standard content provided across all locations but Connect reinforces the regularity of these meetings and the FWAs running them will be more sensitized to first-time parents.

Alongside the wider-scale implementation of these enhancements, Connect will support the Ministry of Health as well as local and international NGOs to sustain the enhancements beyond the donor-funded project.

There are four specific aims for understanding the efficacy for Connect's packages:

1. To estimate the causal impact and cost-effectiveness of Connect's community-level interventions (compared to a control) on the primary outcomes of adoption and continuation of modern PPFP methods and timing and uptake of PNC among FTMs ages 15-24 in Noakhali and Madaripur, Bangladesh.
2. To examine the causal impact of Connect's community-level interventions (compared to a control) on secondary outcomes (specified below) among FTMs ages 15-24 in Noakhali and Madaripur, Bangladesh.
3. To compare the impacts of Connect's community-level interventions on adolescent FTMs (ages 15-19) versus young FTMs (ages 20-24).

• Study Type: Interventional
• Enrollment (Actual): 2308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Cox’s Bāzār, Bangladesh
    • Technical Assistance Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant or has child under 5 months
• Aged 14-25

Exclusion Criteria:

• Younger than 14 or over 25
• Has more than one child or is pregnant and has a child

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connect Community Level Enhancements; At the community level, Connect enhancements build on standard community health worker (CHW) home visits implemented by the government and pre-existing courtyard meetings implemented by the Government of Bangladesh. Courtyard meetings are led by CHWs and convened monthly for new mothers and their families. CHWs sensitize participants to postpartum family planning (PPFP) and share the importance of available services from facilities. Connect reinforces the regularity of these meetings. CHWs receive additional training to be sensitized to the needs of first time parents and engage first-time mothers to attend. Home Visits: CHWs conduct home visits to women who are pregnant or recently gave birth in their catchment areas. During these visits CHWs provide basic care, information on ANC, PNC and PPFP, and provide access to FP methods. Connect targets home visits to first time mothers and those who gave birth at home. They provide print materials to support PPFP and PNC care.	Behavioral: Connect; Community level enhancements
No Intervention: Control; No additional Connect intervention. Pre-existing institutionalized services for expecting and new mothers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption of Postpartum Family Planning (PPFP):	1. Indicator for adopted a modern contraceptive method within 12 months after giving birth (among women who have given birth). Adoption of a modern contraceptive method in the first year after giving birth, among FTMs who have given birth-modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)).	12 months
Currently using PPFP	2. Currently using a modern contraceptive method (among women who have given birth). Modern methods are defined here as male condoms, oral contraceptive pills, injectables, and long-active reversible contraception (LARC) methods (implants and intrauterine device (IUD)).	12 months
Postnatal Care uptake	3. Indicator for received any PNC, among FTMs who have given birth. Uptake of facility-based PNC for mother and baby. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.	12 months
Timing of Postnatal Care (PNC)	4. FTM received PNC within 72 hours of delivery, among FTMs who have given birth more than 72 hours ago. Care that is reported to be a PNC visit but occurs outside of a health facility is not considered a PNC visit for these indicators.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adopted or Intention to adopt PPFP	Indicator for adopt or intention to adopt modern PPFP with 12 months after birth: Using or planning to use a modern contraceptive method to delay or avoid pregnancy within first year of child's life, among all FTMs who have given birth within the past 12 months. Modern methods included in this indicator are: male condoms, oral contraceptive pills, injectables, implants, IUDs	12 months
Quality of additional PNC	We measure quality in two ways: (1) Using an indicator for quality of any of an FTM's PNC contact that occurred more than 24 hours after delivery, among FTMs who received a PNC contact. The indicator is equal to one if received all 17 content areas measured; (2) using a scale (0-17) of the total number of content areas covered out of 17 during any PNC contact that the FTM received more than 24 hours after birth. this score will be calculated by generating an indicator for each content area equal to one if the content was covered and summing the indicators.	12 months
Quality of early PNC	This will be measured in two ways: Indicator for quality of early PNC contact (within 24 hours of delivery) for FTM, among FTMs who received an early PNC contact; Scale (0-10) indicating the total number of content areas covered out of 10 during an early PNC contact, among FTMs who received an early PNC contact. This score is calculated by generating an indicator for each content area equal to one if it was covered, sum the indicators to generate the overall scale.	12 months
Contraceptive Preferences	Contraceptive preferences for modern methods, among all FTMs, measured with an indicator equal to one if the FTM names a modern method (male condom, pill, injectable, implant, IUD) as preferred family planning method if there were no constraints (e.g., cost, access, opinions of others, etc.).	12 months
Quality of Family Planning Counselling	Quality score (0-100), among all FTMs who received family planning counseling. A 22-item quality of care index, adapted from Jain et al. (2019) is combined into a weighted additive index where each of 4 domains have equal weight (1) respectful care, (2) method selection, (3) effective use of method selected, and (4) continuity of contraceptive use and care. For each domain, we will construct an indicator equal to one of the care is of "high quality", defined as having a score that is greater than the mean score plus half of the standard deviation	12 months
Communication and agency	Indicator for FTM discussed FP with husband/partner or other family member, among all FTMs	12 months
PPFP knowledge	PPFP knowledge index of six true/false statements, standardized to the mean and standard deviation of the control group, among all FTMs. The raw index will be the sum of the responses to each individual true/false statement. Raw scores range from 0 to 6, with 6 indicating that all questions were answered correctly. A set of 5 true/false questions adapted from MOMENTUM asked in a random order.	12 months
PPFP Attitudes	PPFP attitudes index of eight attitudes, standardized to the mean and standard deviation of the control group, among all FTMs. The raw index will be the sum of the responses to each individual attitude (score ranging from 1 to 5), with a possible maximum score of 40. Higher scores will indicate less restrictive attitudes with regard to family planning.	12 months
PNC attitudes	PNC attitudes index of four attitudes, standardized to the mean and standard deviation of the control group, among all FTMs. The raw index will be the sum of the responses to each individual attitude (score ranging from 1 to 5), with a possible maximum score of 20. Higher scores will indicate less restrictive attitudes with regard to PNC.	12 months

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Bill and Melinda Gates Foundation; Save the Children; Save the Children International Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): February 2, 2025
• Study Completion (Actual): February 2, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: postpartum family planning; first time mothers; modern contraception
• Additional Relevant MeSH Terms: Behavior; Reproductive Behavior; Contraception Behavior
• Other Study ID Numbers: NCR203091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be made publicly available
• IPD Sharing Time Frame: 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No