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

Background/objectives: The building and then testing of high-quality maternal and infant health care service delivery models are urgently needed to address the persistent maternal and infant health disparities globally. A range of health system and social drivers contribute to maternal and infant morbidities and mortality, including limited access to care and preventive services and variation in care quality. These poor outcomes have led to calls for a broader redesign of maternal and infant health services and delivery systems. One promising model is group care, which has shown potential for maternal and child health care redesign, but has been studied mainly during the antenatal period. This paper describes the study protocol our team will use to evaluate the effectiveness of group postpartum and well-child care. Methods: We will conduct a cluster randomized controlled trial with mixed methods across 16 clinics in Zomba District, Malawi to test the model’s impact on select maternal and infant health outcomes. We hypothesize that compared to usual care, women in the intervention group will have decreased postpartum depression symptoms, anemia, and hypertension and infants will have increased vaccination rates and more optimal secondary outcomes for the dyad, such as uptake of family planning, exclusive breastfeeding, childhood development (gross and fine motor skills, social-adaptive development, and nutrition). We will also qualitatively explore clinic- and patient-level implementation facilitators and barriers for group care and the health and social needs that arise in the 12 months after birth for both women and their infants in both arms. Discussion: This study will be the first to conduct an adequately powered trial of a group postpartum and well-child care model in a low-resource setting. Findings from the study will contribute important evidence on how postpartum and well-child care may be improved during the first year after birth. Trial registration: ClinicalTrials.gov registration number: NCT07414901.