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NCT Number: NCT07414901

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

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.

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Key information

Conditions

Postpartum Health Infant Health

Age range

1 week–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bimbi HC, Zomba, Malawi

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Care

Behavioral

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.

Primary outcomes

  1. 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.

  2. Infant immunization completion rate per national immunization schedule

    Time frame: 6 months, and 12 months after birth

Secondary outcomes

  1. Number of participants using a family planning method

    Time frame: baseline, 6 months and 12 months postpartum

  2. Number of Participants who recall postnatal care content as measured by structured survey

    Time frame: 6 and 12 months postpartum

  3. 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.

  4. 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.

  5. Number of Participants Exclusively breastfeeding at 6 months after birth

    Time frame: 6 months postpartum

  6. 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.

  7. 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.

  8. Maternal anemia - hemoglobin level measured by point-of-care bloodspot test

    Time frame: baseline and 12 months postpartum

  9. 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.

  10. 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.

  11. Maternal mortality as measured by clinic reporting

    Time frame: 6 months and 12 months postpartum

  12. Infant growth as measured by weight-for-age per growth standards

    Time frame: baseline, 6 months, and 12 months after birth

  13. Infant growth as measured by length-for-age per growth standards

    Time frame: baseline, 6 months, 12 months after birth

  14. Infant nutritional status as measured by mid-upper arm circumference (MUAC)

    Time frame: 6 months and 12 months after birth

  15. Infant anemia as measured by point-of-care hemoglobin bloodspot test

    Time frame: 12 months after birth

  16. 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.

  17. Infant mortality as measured by clinic reporting and parent's self-report

    Time frame: 6 months and 12 months after birth

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Gresh

CONTACT

[email protected]

603-831-3942

Ellen Chirwa

CONTACT

[email protected]

+265888940513

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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