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.
The building and testing of high-quality health care service delivery models and practices are urgently needed to substantially reduce global maternal and infant health disparities. Low-resource settings have some of the worst perinatal health outcomes globally. A constellation of health system and social factors contribute to maternal and infant morbidities, including low rates of receipt of health care and preventive services. Unaddressed postpartum morbidities (e.g., depression) can directly impact the health and well-being of the infant, for whom the first year of life is a crucial time for their long-term health. As such, there have been calls for a redesign of maternal and infant health services and systems. Group care is a promising strategy for maternal and child health care redesign, but has primarily been tested in the antenatal setting. Few studies examine extending group care into the postpartum period, integrating postpartum and well-child care in low resource settings. However, opportunities exist to address ongoing maternal and infant morbidities while supporting the transition of the dyad from postpartum to primary care during this critical time in the life course. In 2022, the study team collaboratively adapted an evidence-based group healthcare model and co-designed an integrated group postpartum and well-child care model that extends postnatal care to 12 months while integrating it with well-child care so that the health needs of the dyad are addressed simultaneously. This model brings together 8-10 postpartum women with similarly aged infants to engage in care together. Each visit is 2 hours, with the first 30-45 min devoted to standard clinical health assessments for the dyad and participation in self-assessments, followed by 75-90 min of interactive health promotion activities. Using a cluster randomized controlled trial with mixed methods, the study team will assess the impact of this innovative and proactive group healthcare model at 16 clinics. The investigators will use the same 3-Step Implementation Model that allowed our team to successfully implement and sustain group prenatal care at 7 clinics. The study team will test the hypothesis: compared to usual care, infants will have increased vaccination rates and women will have decreased postpartum depression, anemia, and hypertension, and more optimal secondary outcomes for the dyad, such as uptake of family planning, exclusive breastfeeding, childhood development, and nutrition. The study team will also qualitatively explore the health and health-related social needs that arise in the 12 months after birth for both women and their infants and identify clinic- and patient-level implementation facilitators and barriers. This study will be the first to conduct an adequately powered trial of an integrated group postpartum and well-child care model in a low and-middle income country. This rigorous study will have important public health policy implications for the U.S, where maternal morbidity rates are unacceptably high. Results will provide clinical evidence for improved maternal and infant health care in the first year postpartum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
940
Group care in the postpartum period brings together 6-8 postpartum people with similarly aged infants to engage in care together. Each visit is 2 hours with the first 30-45 min devoted to standard clinical health assessments for the infant and postpartum person and participation in self-assessments such as taking one's own weight and blood pressure. Health assessments are followed by 75-90 min of facilitated, interactive health promotion activities. This 6-visit model across the infants' first year aligns with the infant vaccination schedule and includes Malawi-specific health promotion content for the dyad.
Bimbi HC
Zomba, Malawi
Chamba HC
Zomba, Malawi
Chingale HC
Zomba, Malawi
Domasi HC
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: baseline, 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
Partner communication assessed via 12-item survey with a total score range of 12-48. Higher scores indicate more frequent partner communication.
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Zomba, Malawi
Lambulira HC
Zomba, Malawi
Likangala HC
Zomba, Malawi
M'mambo HC
Zomba, Malawi
Machinjiri HC
Zomba, Malawi
Maera HC
Zomba, Malawi
Makwapala
Zomba, Malawi
...and 6 more locations
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, 6 months, 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
Time frame: 6 months and 12 months after birth