Actively Recruiting
Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes
Led by Johns Hopkins University · Updated on 2026-05-07
1125
Participants Needed
16
Research Sites
8 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an integrated group postpartum and well-child care model compared to the usual individual care for mothers and their infants. The study aims to improve maternal and infant health outcomes during the first year after birth and provide insights to enhance health service delivery in low-resource settings. This cluster randomized controlled trial is conducted in 16 clinics in Zomba District, Malawi. The study compares group care, where 8-10 women and their infants born within one month meet together for integrated health sessions, with usual individual care. Group care sessions last 120 minutes and include self-assessments, clinical health checks, and interactive health promotion activities. These sessions occur six times, aligned with the Malawian vaccination schedule at 6 weeks, 10 weeks, 14 weeks, 6 months, 9 months, and 12 months postpartum. Participants will be involved in data collection at baseline, 6 months, and 12 months to assess outcomes such as postpartum depression, infant immunization rates, breastfeeding, maternal and infant nutrition, anxiety, growth, and mortality. The study also includes interviews to explore social and health needs and barriers to group care. Monitoring includes clinical assessments, surveys, and point-of-care tests over the first year postpartum.
CONDITIONS
Brief Title
Group Postpartum and Well-Child Care for Maternal and Infant Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women presenting for their 1-week postnatal care visit with their infant at a study site clinic
- Age 15 years or older
- Infant less than 4 weeks old
- Able to speak and understand Chichewa
- Adolescents aged 15-17 must have parent/guardian consent and assent
- Infants included as part of mother-infant pair
You will not qualify if you...
- Under age 15
- Serious physical or mental illness or marked cognitive impairment preventing informed consent
- Unable to participate in the full intervention
- Multiple infants (e.g., twins, triplets)
- For co-facilitators or stakeholders: serious physical or mental illness or marked cognitive impairment preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One year postpartum
Participants join a group postpartum and well-child care program where 8-10 women and their infants meet for integrated healthcare. Each session includes self-assessments and clinician health assessments followed by interactive health promotion, skills-building, and support activities.
6 visits aligned with the Malawian vaccine schedule at 6 weeks, 10 weeks, 14 weeks, 6 months, 9 months, and 12 months
Trial Site Locations
Total: 16 locations
1
Bimbi HC
Zomba, Malawi
Not Yet Recruiting
2
Chamba HC
Zomba, Malawi
Actively Recruiting
3
Chingale HC
Zomba, Malawi
Not Yet Recruiting
4
Domasi HC
Zomba, Malawi
Not Yet Recruiting
5
Lambulira HC
Zomba, Malawi
Not Yet Recruiting
6
Likangala HC
Zomba, Malawi
Actively Recruiting
7
M'mambo HC
Zomba, Malawi
Not Yet Recruiting
8
Machinjiri HC
Zomba, Malawi
Not Yet Recruiting
9
Maera HC
Zomba, Malawi
Not Yet Recruiting
10
Makwapala
Zomba, Malawi
Not Yet Recruiting
11
Matawale HC
Zomba, Malawi
Actively Recruiting
12
Mwandama HC
Zomba, Malawi
Not Yet Recruiting
13
Naisi HC
Zomba, Malawi
Actively Recruiting
14
Namasalima HC
Zomba, Malawi
Not Yet Recruiting
15
Nasawa
Zomba, Malawi
Not Yet Recruiting
16
Ngwelero HC
Zomba, Malawi
Not Yet Recruiting
Research Team
A
Ashley Gresh
E
Ellen Chirwa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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