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Group Postpartum and Well-Child Care for Maternal and Infant Health

Group Postpartum and Well-Child Care for Maternal and Infant Health

Recruiting
1-75 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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.

Study details
    Postpartum Health
    Infant Health

NCT07414901

Johns Hopkins University

13 May 2026

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