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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
University of Michigan
Kamuzu University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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