An interventional study of Group Care in Postpartum Health and Infant Health, sponsored by Johns Hopkins University. Recruiting at 16 sites in Malawi. Open to participants aged 1 Week to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
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.
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.
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aims 1\&2:
Aim 3:
Exclusion Criteria:
Aim 1\&2
Aim 3
-Serious physical or mental illness or marked cognitive impairment preventing informed consent.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS)
The EPDS is a 10-item self-report scale with scores ranging from 0-30; higher scores indicate more depressive symptoms.
Time frame: baseline, 6 months, and 12 months postpartum
Infant immunization completion rate per national immunization schedule
Time frame: 6 months, and 12 months after birth
Number of participants using a family planning method
Time frame: 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
Self-reported peer connectedness as measured by study survey
Peer connectedness assessed via a 14-item survey. Total score range: 0-56. Higher scores indicate greater peer connectedness.
Time frame: 6 and 12 months postpartum
Breastfeeding self-efficacy as measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
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.
Time frame: baseline, 6 months and 12 months postpartum
Number of Participants Exclusively breastfeeding at 6 months after birth
Time frame: 6 months postpartum
Partner communication as measured by relationship quality survey
2-item survey with total score range 0-2. Higher scores indicate higher relationship quality.
Time frame: baseline, 6 months, and 12 months postpartum
Maternal nutrition as measured by dietary diversity survey
Dietary diversity assessed via 6-item 24-hour recall with a total score range of 0-6. Higher scores indicate greater dietary diversity.
Time frame: 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
Hypertension as measured by blood pressure assessment
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.
Time frame: baseline, 6 months, and 12 months postpartum
Postpartum anxiety as measured by the Generalized Anxiety Disorder 7-item Scale (GAD-7)
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.
Time frame: baseline, 6 months, and 12 months postpartum
Maternal mortality as measured by clinic reporting
Time frame: 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
Infant growth as measured by length-for-age per growth standards
Time frame: 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
Infant anemia as measured by point-of-care hemoglobin bloodspot test
Time frame: 12 months after birth
Child development as measured by the Malawi Developmental Assessment Tool (MDAT)
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.
Time frame: 6 months and 12 months after birth
Infant mortality as measured by clinic reporting and parent's self-report
Time frame: 6 months and 12 months after birth
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Nov 2029, 44 months after the start.
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