NCT07414901

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,125 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 1 Week – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postpartum Health
• Infant Health

Interventions

Type	Name	Description
BEHAVIORAL	Group Care	Group care in the postpartum period brings the same group of 8-10 women and their infants, born within one month of one another, together for one year of integrated healthcare for the dyad. Sessions are co-facilitated by a midwife and HSA. Each session is 120 minutes: first 30-45 minutes consist of self-assessments (measuring infant's weight/length, taking own vital signs) and standard health assessments by a clinician; health concerns are identified/managed and referrals made if needed. Followed by 75-90 minutes of interactive health promotion, skills-building, and support activities. 6-visit model aligned with Malawian vaccine schedule: 6 weeks, 10 weeks, 14 weeks, 6 months, 9 months, and 12 months.

Timeline

• Start date: 2026-03-30
• Primary completion: 2029-11-30
• Completion: 2030-01-30
• First posted: 2026-02-17
• Last updated: 2026-04-15

Locations

16 sites across 1 country: Malawi