Postpartum HealthNCT07414901
Group Postpartum and Well-Child Care for Maternal and Infant Health
A study testing Group Care in people with Postpartum Health and Infant Health, run by Johns Hopkins University at 16 sites in Malawi.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 week to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum Health, Infant Health
- What is being tested?
- Group Care
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,125 participants
- Where
- 16 sitesMalawi
- Study dates
- 30 Mar 2026to 30 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Malawi16 sites, 16 recruiting
- Not yet recruiting
Bimbi HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Chamba HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Not yet recruiting
Chingale HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Not yet recruiting
Domasi HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Lambulira HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Likangala HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Not yet recruiting
M'mambo HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Machinjiri HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Not yet recruiting
Maera HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Makwapala
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Matawale HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Not yet recruiting
Mwandama HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Naisi HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Recruiting
Namasalima HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Not yet recruiting
Nasawa
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
- Not yet recruiting
Ngwelero HC
Zomba
Ellen Chirwa, embweza@kuhes.ac.mw
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Health, Infant Health
- Being tested
- Group Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Care | Experimental | Not described Receives: Behavioral: Group Care |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 months, and 12 months postpartum
Infant immunization completion rate per national immunization schedule
Measured: 6 months, and 12 months after birth
Secondary outcomes (17)
Number of participants using a family planning method
Measured: baseline, 6 months and 12 months postpartum
Number of Participants who recall postnatal care content as measured by structured survey
Measured: 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.
Measured: 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.
Measured: baseline, 6 months and 12 months postpartum
Number of Participants Exclusively breastfeeding at 6 months after birth
Measured: 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.
Measured: 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.
Measured: baseline, 6 months, and 12 months postpartum
Maternal anemia - hemoglobin level measured by point-of-care bloodspot test
Measured: 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.
Measured: 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.
Measured: baseline, 6 months, and 12 months postpartum
Maternal mortality as measured by clinic reporting
Measured: 6 months and 12 months postpartum
Infant growth as measured by weight-for-age per growth standards
Measured: baseline, 6 months, and 12 months after birth
Infant growth as measured by length-for-age per growth standards
Measured: baseline, 6 months, 12 months after birth
Infant nutritional status as measured by mid-upper arm circumference (MUAC)
Measured: 6 months and 12 months after birth
Infant anemia as measured by point-of-care hemoglobin bloodspot test
Measured: 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.
Measured: 6 months and 12 months after birth
Infant mortality as measured by clinic reporting and parent's self-report
Measured: 6 months and 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start30 Mar 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HealthStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Michigan, Kamuzu University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Ashley Gresh, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414901
- Sponsor's protocol ID
- IRB00492477
- Other IDs
- R01NR021403
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an Integrated Group Postpartum and Well-child Care Model on Maternal and Child Health Outcomes
- ClinicalTrials.gov ID
- NCT07414901
- Acronym / sponsor ID
- IRB00492477
- Conditions
- Postpartum Health, Infant Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,125 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Michigan, Kamuzu University of Health Sciences
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Care | Experimental | Behavioral: Group Care |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 1 week to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CareGroup 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. | Behavioural | Group Care |
Primary outcome
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.
Infant immunization completion rate per national immunization schedule
Time frame: 6 months, and 12 months after birth
17 secondary outcomes
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
Time frame: 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
Number of Participants Exclusively breastfeeding at 6 months after birth
Time frame: 6 months postpartum
Partner communication as measured by relationship quality survey
Time frame: baseline, 6 months, and 12 months postpartum
Maternal nutrition as measured by dietary diversity survey
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
Time frame: 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
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Gresh principal investigator
Johns Hopkins University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Care in people with Postpartum Health and Infant Health, run by Johns Hopkins University at 16 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Gresh (603-831-3942, ashley.gresh@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum depression score as measured by the Edinburgh Postnatal Depression Scale (EPDS) (time frame: baseline, 6 months, and 12 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.