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ClinicalTrials.gov ID

NCT07414901

Lead Sponsor

Johns Hopkins UniversityOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,125Estimated

Last Update Posted

Jul 9, 2026Actual

Start Date

Mar 30, 2026Actual

Primary Completion Date

Nov 30, 2029Estimated

Completion Date

Jan 30, 2030Estimated

Official Title

Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes

Brief Summary

The proposed study will evaluate the effectiveness of an integrated group postpartum and well-child care model, compared to individual (usual) postnatal and well-child care, on maternal and child health outcomes. Results will provide clinical evidence for improved maternal and infant health care in the first year postpartum. The study will inform and provide lessons learned to advance maternal and infant health service delivery models in low resource settings.

Detailed Description

A cluster randomized controlled trial design with mixed methods will be used to determine the impact and comparative effectiveness of group versus usual individual care with postpartum women and the women's infants in 16 clinics across Zomba District, Malawi. Data is collected at baseline, 6- and 12-months. Women are nested within the postpartum/well-child care group for the intervention. In the control arm, dyads will be grouped based on order of entry within each site. The first 10 dyads will form "group" 1, the second 10 dyads "group" 2, etc. The investigators will also explore the health and health-related social needs that arise in the 12 months after birth for both women and the women's infants through in-depth interviews as well as implementation barriers and facilitators for group postpartum and well-child care.

• Postpartum Health
• Infant Health

• Group Care

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

Aims 1&2:

• Women presenting for their 1-week postnatal care visit with their infant at a study site clinic.
• Over age 15.
• One infant is less than 4 weeks old.
• Able to speak and understand Chichewa.
• Adolescents 15-17 must bring parent/guardian for consent/assent. Infants included as part of mother-infant dyad.

Aim 3:

• Midwife or HSA serving as group care co-facilitator or key stakeholders in MoH/Zomba District/clinical administration
• Able to speak Chichewa and/or English.

Exclusion Criteria:

Aim 1&2

• Under age 15.
• Serious physical or mental illness or marked cognitive impairment preventing informed consent.
• Inability to participate in full intervention
• Multiple infants (e.g. twins, triplets)

Aim 3

-Serious physical or mental illness or marked cognitive impairment preventing informed consent.

Primary Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Johns Hopkins UniversityOTHER

Collaborators

National Institute of Nursing Research (NINR)NIH

University of MichiganOTHER

Kamuzu University of Health SciencesOTHER

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw

embweza@kuhes.ac.mw