Group postpartum and well-child care for mothers and babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chamba HC
  Zomba, Malawi Recruiting
• Lambulira HC
  Zomba, Malawi Recruiting
• Likangala HC
  Zomba, Malawi Recruiting
• Machinjiri HC
  Zomba, Malawi Recruiting
• Makwapala
  Zomba, Malawi Recruiting
• Matawale HC
  Zomba, Malawi Recruiting

Study contacts

• Principal investigator: Ashley Gresh — Johns Hopkins University
• Study coordinator: Ashley Gresh
• Email: ashley.gresh@jhu.edu
• Phone: 603-831-3942

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.