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Recruiting
NCT07414901
Group Postpartum and Well-Child Care for Maternal and Infant Health
Conditions: Postpartum Health, Infant Health
Sex: All
Ages: 1 Week – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 1125
Sponsor: Johns Hopkins University
Location: Bimbi HC Zomba
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.
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.
Source: ClinicalTrials.gov (NCT07414901). StuddyBuddy aggregates publicly available trial information.