Group Postpartum and Well-Child Care for Maternal and Infant Health

May 6, 2026 updated by: Johns Hopkins University

Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A cluster randomized controlled trial design with mixed methods will be used to determine the impact and comparative effectiveness of group versus usual individual care with postpartum women and the women's infants in 16 clinics across Zomba District, Malawi. Data is collected at baseline, 6- and 12-months. Women are nested within the postpartum/well-child care group for the intervention. In the control arm, dyads will be grouped based on order of entry within each site. The first 10 dyads will form "group" 1, the second 10 dyads "group" 2, etc. The investigators will also explore the health and health-related social needs that arise in the 12 months after birth for both women and the women's infants through in-depth interviews as well as implementation barriers and facilitators for group postpartum and well-child care.

Study Type

Interventional

Enrollment (Estimated)

1125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Group Care
Behavioral: Group Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: baseline, 6 months, and 12 months postpartum
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
Time Frame: 6 months, and 12 months after birth
6 months, and 12 months after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants using a family planning method
Time Frame: baseline, 6 months and 12 months postpartum
baseline, 6 months and 12 months postpartum
Number of Participants who recall postnatal care content as measured by structured survey
Time Frame: 6 and 12 months postpartum
6 and 12 months postpartum
Self-reported peer connectedness as measured by study survey
Time Frame: 6 and 12 months postpartum
Peer connectedness assessed via a 14-item survey. Total score range: 0-56. Higher scores indicate greater peer connectedness.
6 and 12 months postpartum
Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Time Frame: baseline, 6 months and 12 months postpartum
The BSES-SF is a 14-item self-report scale with a total score range of 14-70. Higher scores indicate greater breastfeeding self-efficacy.
baseline, 6 months and 12 months postpartum
Number of Participants Exclusively breastfeeding at 6 months after birth
Time Frame: 6 months postpartum
6 months postpartum
Maternal nutrition as measured by dietary diversity survey
Time Frame: baseline, 6 months, and 12 months postpartum
Dietary diversity assessed via 6-item 24-hour recall with a total score range of 0-6. Higher scores indicate greater dietary diversity.
baseline, 6 months, and 12 months postpartum
Hypertension as measured by blood pressure assessment
Time Frame: baseline, 6 months, and 12 months postpartum
Hypertension assessed by systolic and diastolic blood pressure measurement in mmHg. Hypertension defined as systolic ≥140 mmHg and/or diastolic ≥90 mmHg per WHO guidelines.
baseline, 6 months, and 12 months postpartum
Postpartum anxiety as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time Frame: baseline, 6 months, and 12 months postpartum
Anxiety symptoms assessed using the GAD-7, a 7-item self-report scale with a total score range of 0-21. Higher scores indicate greater anxiety.
baseline, 6 months, and 12 months postpartum
Maternal mortality as measured by clinic reporting
Time Frame: 6 months and 12 months postpartum
6 months and 12 months postpartum
Infant growth as measured by weight-for-age per growth standards
Time Frame: baseline, 6 months, and 12 months after birth
baseline, 6 months, and 12 months after birth
Infant growth as measured by length-for-age per growth standards
Time Frame: baseline, 6 months, 12 months after birth
baseline, 6 months, 12 months after birth
Infant nutritional status as measured by mid-upper arm circumference (MUAC)
Time Frame: 6 months and 12 months after birth
6 months and 12 months after birth
Infant anemia as measured by point-of-care hemoglobin bloodspot test
Time Frame: 12 months after birth
12 months after birth
Child development as measured by the Malawi Developmental Assessment Tool (MDAT)
Time Frame: 6 months and 12 months after birth
Child development assessed using the MDAT, a tool measuring four domains: gross motor, fine motor, language, and social development. Each domain is scored 0-34 based on passed items. Total score range: 0-136. Higher scores indicate more advanced development.
6 months and 12 months after birth
Partner communication as measured by relationship quality survey
Time Frame: baseline, 6 months, and 12 months postpartum
2-item survey with total score range 0-2. Higher scores indicate higher relationship quality.
baseline, 6 months, and 12 months postpartum
Maternal anemia - hemoglobin level measured by point-of-care bloodspot test
Time Frame: baseline and 12 months postpartum
baseline and 12 months postpartum
Infant mortality as measured by clinic reporting and parent's self-report
Time Frame: 6 months and 12 months after birth
6 months and 12 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Nursing Research (NINR)
University of Michigan
Kamuzu University of Health Sciences

Investigators

  • Principal Investigator: Ashley Gresh, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2026

Primary Completion (Estimated)

November 30, 2029

Study Completion (Estimated)

January 30, 2030

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00492477
  • R01NR021403 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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