Actively Recruiting

Phase Not Applicable
Age: 1Week - 75Years
All Genders
Healthy Volunteers
ID07414901

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

Age: 1Week - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Group Care

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

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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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