Leveraging and strengthening local systems to increase first-time mothers’ use of postpartum family planning and improve post-natal care in Bangladesh: A cluster randomized control trial of Connect-Bangladesh

Last registered on September 26, 2024

Pre-Trial

Trial Information

General Information

Title
Leveraging and strengthening local systems to increase first-time mothers’ use of postpartum family planning and improve post-natal care in Bangladesh: A cluster randomized control trial of Connect-Bangladesh
RCT ID
AEARCTR-0013842
Initial registration date
June 18, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
June 25, 2024, 10:37 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
September 26, 2024, 10:02 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Primary Investigator

Affiliation
George Washington University

Other Primary Investigator(s)

PI Affiliation
George Washington University

Additional Trial Information

Status
On going
Start date
2023-05-15
End date
2025-12-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
While a growing body of programs have shown promise to increase uptake of postpartum family planning (PPFP) among first time mothers (FTMs), difficulties remain in scaling beyond small pilot areas and institutionalizing within existing systems. Likewise, despite the importance of post-natal care (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 postnatal home visits (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. We will evaluate Connect's approach through a cluster randomized control trial.

Registration Citation

Citation
Baird, Sarah and Jennifer Seager. 2024. "Leveraging and strengthening local systems to increase first-time mothers’ use of postpartum family planning and improve post-natal care in Bangladesh: A cluster randomized control trial of Connect-Bangladesh." AEA RCT Registry. September 26. https://doi.org/10.1257/rct.13842-1.1
Experimental Details

Interventions

Intervention(s)
In Bangladesh, the Connect project layers light-touch interventions, called “enhancements,” onto a larger USAID-funded project, called MaMoni MNCSP, and existing government supported platforms. Connect supported the Ministry of Health & Family Welfare (MOH&FW) to introduce a targeted PNC approach, including PPFP, at facility and community levels. Connect began small-scale testing in two upazilas in the Noakhali District (Kabirhat and Companiganj) in January 2021.

For the cluster randomlzed controlled trial (cRCT), the activities were expanded to two new upazilas in Noakhali (Begumgonj and Subarnachar) starting in June of 2023 and introduced in two upazilas in Madaripur (Sadar and Kalkini) starting in December of 2023.

Community Level

At the community level, Connect enhancements build on standard FWA home visits implemented by the government (not MaMoni supported) and pre-existing courtyard meetings implemented by the Government of Bangladesh.
Courtyard meetings are one of the strategies that the Bangladesh family planning (FP) program uses to disseminate FP messages and provide access to contraceptives. These meetings, which are led by FWAs, are convened monthly in the FWAs’ catchment area Courtyard meetings are implemented by the Expanded Program on Immunization (EPI), an existing government platform. These meetings are open for all community members to participate. FWAs facilitate discussion on maternal and child health and family planning and sensitize all participants to the importance of accessing maternal and child health services across the continuum of care. They also provide access to short-acting FP (e.g., condoms, contraceptive pills, second dose of Injectables) and referrals for long-acting methods (i.e., implants, IUD) during these meetings. Connect enhanced these meetings by reinforcing the regularity of these meetings, ensuring they occurred as scheduled. In addition, Connect provided additional training to FWAs to sensitize them to the needs of first-time parents and to particularly encourage attendance of first-time mothers (see more detail under home visits).

Home visits are conducted by FWAs and Paid volunteers (PVs) across all communities. FWAs and PVs identify women who are currently pregnant or recently gave birth in their assigned catchment areas through regular rotations. During home visits, FWAs and PVs provide information to new mothers on ANC, PNC, and PPFP; and distribute short-acting FP methods (e.g., condoms, contraceptive pills, second dose of injectables) and provide referrals for long-acting methods (e.g., implants, IUD). Connect enhanced these home visits by adjusting the procedure for targeting mothers and the content provided during those meetings. First, FWAs are provided a risk-stratification assessment checklist (algorithm) to identify at-risk mother-baby dyads to prioritize for home visits. In particular, first-time mothers and mothers who give birth at home are prioritized for these visits. Second, FWAs and PVs are provided additional training on the needs of first-time parents. They are trained to provide referrals to facility-based providers for ANC, delivery, and PNC; to encourage facility delivery; to advertise the existence and timing of courtyard meetings, and to involve other family members during the home visit. Third, Connect introduced two materials that are distributed during these home visits: an invitation card that provides information on the nearest facility, encourage FTMs to attend the facility for ANC, delivery, PNC, and PPFP and link the mother with the facility-based service providers and a mother-baby booklet that provides mothers with reference information on the continuum of care, from ANC to PNC and PPFP and role of other family members towards FTM. These materials are also distributed by facility-based providers during facility visits.

Facility Level

At the facility level, Connect enhancements build on standard provider training on PPFP counselling, PNC and postpartum intrauterine contraceptive device (IUD) insertion. Connect introduces a PNC Quality Improvement bundle and a pre-discharge counselling checklist that provide guidance on recommended actions depending on the condition of the FTM after giving birth at a facility and outlines information to provide the FTM around best practices for taking care of herself and her baby after going home, warning signs to watch out for, postpartum family planning, and when to return to the facility for PNC.

Interventions being evaluated by the cRCT

The cRCT is specifically focuses on evaluating enhancements at the community level delivered by the FWA.
Intervention (Hidden)
Intervention Start Date
2023-06-06
Intervention End Date
2024-08-31

Primary Outcomes

Primary Outcomes (end points)
Adoption and continuation of Postpartum Family Planning (PPFP): 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)). We will use the following indicators to measure adoption and continuation of PPFP:
1. Indicator for adopted a modern contraceptive method within 12 months after giving birth (among women who have given birth).
2. Indicator for currently using a modern contraceptive method (among women who have given birth).

Postnatal Care (PNC) uptake and timing: Uptake of facility-based PNC for mother and baby and timing of PNC visits within key time periods, among FTMs who have given birth. 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. We will use the following indicators to measure uptake and timing of PNC:
3. Indicator for received any PNC, among FTMs who have given birth.
4. FTM received PNC within 72 hours of delivery, among FTMs who have given birth more than 72 hours ago.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
See protocol/pre-analysis plan
Secondary Outcomes (explanation)
See protocol/pre-analysis plan

Experimental Design

Experimental Design
This study will operate in two upazilas in two districts within Bangladesh: Noakhali (Begumganj and Subarachar) and Madaripur (Madaripur Sadar and Kalkini). The two districts were selected in consultation with MaMoni MNCSP, Technical Advisory Group and the local government through discussions with Save the Children. At the time of baseline, there were 18 Family Planning Inspector (FPI) in place in study upazilas in Noakhali and 27 FPIs in Madaripur. All FPIs are available for randomization. The FPI oversees groups of Family Welfare Assistants (FWAs) who conduct pregnancy-related home visits upon which community-level enhancements are layered, and is the level at which these visits are organized within the Bangladesh health system. Each FPI typically serves one union within a upazila.

We conduct FPI-level (cluster) randomization to reduce the possibility of crossover from treatment and control FTMs. We stratified randomization by upazila and the reported vacancy rate of FWAs for the FPI’s catchment area (above below the mean vacancy rate of 40%).
Experimental Design Details
Randomization Method
Randomization was done using Stata. We started with a dataset listing the FPIs in the selected upazilas. We generated a random variable for each FPI using the runiform() function and ordered the FPIs within designated strata. Within strata, the first FPI was treatment, the second was control, third treatment, continuing until all FPIs had been assigned to either treatment or control.
Randomization Unit
Family Planning Inspector (FPI)
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
45
Sample size: planned number of observations
3,150 first time mothers
Sample size (or number of clusters) by treatment arms
22 treatment FPIs, 23 control FPIs
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
While the target sample size was 45 clusters and 3,150 first time mothers, in reality, we eded up with 45 clusters and 2,300 first time mothers. Postpartum family planning (PPFP) adoption: Given this sample, using the following assumptions (alpha=0.05; ICC=0.05; coefficient of variation of 0.5; 12% attrition; PPFP adoption in the control group is 40%) the minimum detectable effect is 12 percentage points. PNC receipt For PNC, we expect to have an impact on PNC only among the women who were pregnant at baseline (56% of the sample). Given this sample, using the following assumptions (alpha=0.05; ICC=0.05; coefficient of variation of 0.5; 12% attrition; PNC receipt in the control group is 50%) the minimum detectable effect is 13 percentage points in the subsample.
IRB

Institutional Review Boards (IRBs)

IRB Name
George Washington University Committee on Human Research
IRB Approval Date
2022-10-04
IRB Approval Number
NCR203091
IRB Name
Institutional review Board of the Institute for Health Economics, Dhaka University
IRB Approval Date
2023-03-29
IRB Approval Number
IHE/IRB/DU/09/2023/Final
Analysis Plan

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Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials