Group Postpartum and Well-Child Care for Maternal and Infant Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-75
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Group Care
BehavioralGroup 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.
Treatment groups
1,125 Participants
are divided into 2 treatment groupsGroup A: Group CareExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 postpartum2
Infant immunization completion rate per national immunization schedule
Time frame
6 months, and 12 months after birthSecondary outcomes
1
Number of participants using a family planning method
Time frame
baseline, 6 months and 12 months postpartum2
Number of Participants who recall postnatal care content as measured by structured survey
Time frame
6 and 12 months postpartum3
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 postpartum4
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 postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
University of Michigan
Collaborator
Kamuzu University of Health Sciences
Collaborator
Source ClinicalTrials.gov