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
2 other identifiers
interventional
1,125
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2030
April 15, 2026
April 1, 2026
3.7 years
February 11, 2026
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS)
The EPDS is a 10-item self-report scale with scores ranging from 0-30; higher scores indicate more depressive symptoms.
baseline, 6 months, and 12 months postpartum
Infant immunization completion rate per national immunization schedule
6 months, and 12 months after birth
Secondary Outcomes (17)
Number of participants using a family planning method
baseline, 6 months and 12 months postpartum
Number of Participants who recall postnatal care content as measured by structured survey
6 and 12 months postpartum
Self-reported peer connectedness as measured by study survey
6 and 12 months postpartum
Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
baseline, 6 months and 12 months postpartum
Number of Participants Exclusively breastfeeding at 6 months after birth
6 months postpartum
- +12 more secondary outcomes
Study Arms (2)
Group Care
EXPERIMENTALUsual care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- University of Michigancollaborator
- National Institute of Nursing Research (NINR)collaborator
- Kamuzu University of Health Sciencescollaborator
Study Sites (16)
Bimbi HC
Zomba, Malawi
Chamba HC
Zomba, Malawi
Chingale HC
Zomba, Malawi
Domasi HC
Zomba, Malawi
Lambulira HC
Zomba, Malawi
Likangala HC
Zomba, Malawi
M'mambo HC
Zomba, Malawi
Machinjiri HC
Zomba, Malawi
Maera HC
Zomba, Malawi
Makwapala
Zomba, Malawi
Matawale HC
Zomba, Malawi
Mwandama HC
Zomba, Malawi
Naisi HC
Zomba, Malawi
Namasalima HC
Zomba, Malawi
Nasawa
Zomba, Malawi
Ngwelero HC
Zomba, Malawi
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley Gresh
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2026
First Posted
February 17, 2026
Study Start
March 30, 2026
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
January 30, 2030
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share