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A community-based study to improve uptake of prenatal care of mothers in rural India

The Barakat Bundle study: A community-based pragmatic cluster randomized trial to improve uptake of antenatal care regimen through an evidence-based bundle intervention implemented in rural India - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079209
Enrollment
696
Registered
2025-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O80-O82- Encounter for delivery

Interventions

Intervention1: Barakat Bundle: The intervention group will receive standard care and the Barakat Bundle, which includes health education on breastfeeding, handwashing, nutrition, thermal care, and mat

Sponsors

Barakat Bundle, Inc.
Lead Sponsor
Healthprizm Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women who register with Community Health Workers (CHW) with specific Barakat Bundle training before 21 weeks gestation. Pregnant women aged 18 years or more. Pregnant women willing and capable of meeting all study requirements. Pregnant women willing and capable of providing written (signed/thumb impression) informed consent.

Exclusion criteria

Exclusion criteria: Pregnant women who register their pregnancy with Community Health Workers (CHW) with specific Barakat Bundle training after 21 weeks gestation. Pregnant women aged younger than 18 years. Pregnant women who have previously received a Barakat Bundle during the study duration. Pregnant women who intend to move between their marital and maternal home during their pregnancy or within the first month of birth.

Design outcomes

Primary

MeasureTime frame
Number of completed antenatal care visits plus facility deliveryTimepoint: Baseline (ie before 21 weeks gestation) 11 weeks (ie approx 32 weeks gestation 19 weeks (ie approx within one week after gestation)

Secondary

MeasureTime frame
The secondary outcomes will include Use of clean delivery kit at birth Maternal anemia Possible serious bacterial infection between birth & twenty-eight days of age Timing of initiation of skin-to-skin contact Maternal-infant bonding Among the intervention group the following information will also be collected Adherence to Multiple Micronutrient Supplements Rates of utilization of Barakat Bundle items Maternal satisfaction with Barakat Bundle items Timepoint: Outcomes data will be collected At pregnancy registration with Community Health Workers (CHW) with specific Barakat Bundle training, before 21 weeks gestation The fourth antenatal care visit, approximately 32 weeks gestation One to three days after birth, during routine postnatal visits at home Twenty-eight days after birth, during routine postnatal visits at home

Countries

India

Contacts

Public ContactLeena Bhardwaj

Amity University

lbhardwaj@ggn.amity.edu919958358

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026