Group postpartum and well-child care for mothers and babies

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

We will test whether group postpartum and well-child care for new mothers and their babies in Zomba District, Malawi leads to better maternal and infant health over the first year after birth compared with usual individual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1125 (estimated)
• Ages: 1 Week to 75 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 16 sites (Zomba and 15 other locations)
• Trial ID: NCT07414901 on ClinicalTrials.gov

What this trial studies

A cluster randomized controlled trial will compare integrated group postpartum and well-child care to usual individual care across 16 clinics in Zomba District, Malawi. Women and their infants are enrolled at the 1-week postnatal visit and followed at baseline, 6 months, and 12 months, with women nested within group care sessions while control dyads are grouped by order of entry. The trial uses mixed methods including quantitative outcome measures and in-depth qualitative interviews to explore maternal and infant health needs as well as implementation barriers and facilitators. Results will provide evidence on whether the group model improves outcomes and how it could be delivered in low-resource settings.

Who should consider this trial

Good fit: Ideal participants are women older than 15 presenting with a single infant less than 4 weeks old at a participating Zomba District clinic who can speak and understand Chichewa (adolescents 15–17 require a parent/guardian for consent/assent).

Not a fit: Those under 15, with serious physical or mental illness or cognitive impairment, with multiple births, or unable to participate in the full intervention may not benefit from this group care model.

Why it matters

Potential benefit: If successful, the group model could improve health and healthcare engagement for mothers and infants in the first postpartum year and offer a scalable approach for low-resource clinics.

How similar studies have performed: Related group antenatal care programs have shown improved engagement and some maternal outcomes, but combined group postpartum and well-child care is less well tested in low-resource settings.

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.

Where this trial is running

Zomba and 15 other locations

• Bimbi HC — Zomba, Malawi (Not_yet_recruiting)
• Chamba HC — Zomba, Malawi (Recruiting)
• Chingale HC — Zomba, Malawi (Not_yet_recruiting)
• Domasi HC — Zomba, Malawi (Not_yet_recruiting)
• Lambulira HC — Zomba, Malawi (Not_yet_recruiting)
• Likangala HC — Zomba, Malawi (Recruiting)
• M'mambo HC — Zomba, Malawi (Not_yet_recruiting)
• Machinjiri HC — Zomba, Malawi (Not_yet_recruiting)
• Maera HC — Zomba, Malawi (Not_yet_recruiting)
• Makwapala — Zomba, Malawi (Not_yet_recruiting)
• Matawale HC — Zomba, Malawi (Recruiting)
• Mwandama HC — Zomba, Malawi (Not_yet_recruiting)
• Naisi HC — Zomba, Malawi (Recruiting)
• Namasalima HC — Zomba, Malawi (Not_yet_recruiting)
• Nasawa — Zomba, Malawi (Not_yet_recruiting)
• Ngwelero HC — Zomba, Malawi (Not_yet_recruiting)

Study contacts

• Principal investigator: Ashley Gresh — Johns Hopkins University
• Study coordinator: Ashley Gresh

Conditions Postpartum Health; Infant Health