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Contraceptive UsageConnect BDNCT06666036

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

A study testing Connect in people with Contraceptive Usage, run by George Washington University at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraceptive Usage
What is being tested?
Connect
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,308 participants
Where
1 siteBangladesh
Study dates
15 May 2023to 2 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Technical Assistance Inc

    Cox’s Bāzār

Other trials in Bangladesh

About this study

Official title: 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.

Read the 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).
Being tested
Connect
Keywords
postpartum family planning, first time mothers, modern contraception
Medical subject headings
Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConnectBehavioural

    Community level enhancements

Study groups in NCT06666036
Study groupRoleWhat they receive
Connect Community Level EnhancementsExperimentalAt 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.
Receives: Behavioral: Connect
ControlNo interventionNo additional Connect intervention. Pre-existing institutionalized services for expecting and new mothers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)).

    Measured: 12 months

  2. Currently using PPFP

    1. 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)).

    Measured: 12 months

  3. Postnatal Care uptake

    1. 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.

    Measured: 12 months

  4. Timing of Postnatal Care (PNC)

    1. 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.

    Measured: 12 months

Secondary outcomes (9)

  1. 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

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. Quality of early PNC

    This will be measured in two ways:

    1. Indicator for quality of early PNC contact (within 24 hours of delivery) for FTM, among FTMs who received an early PNC contact
    2. 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.

    Measured: 12 months

  4. 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.).

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. Communication and agency

    Indicator for FTM discussed FP with husband/partner or other family member, among all FTMs

    Measured: 12 months

  7. 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.

    Measured: 12 months

  8. 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.

    Measured: 12 months

  9. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2024
  2. Study start15 May 2023
  3. Primary completion2 Feb 2025
  4. Study completion2 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666036
Sponsor's protocol ID
NCR203091
Acronym
Connect BD
Status last verified
Feb 2026
First submitted
29 Oct 2024
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data will be made publicly available

Questions about this trial

What is this clinical trial studying?

A study testing Connect in people with Contraceptive Usage, run by George Washington University at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adoption of Postpartum Family Planning (PPFP): (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06666036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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