Effects of a multi-faceted intervention to improve intrapartum care: A stepped-wedge, cluster-randomized trial in 16 hospitals in Benin, Malawi, Tanzania and Uganda

We developed the facility-based, four-component A ction L everaging E vidence to r educe perinatal Mor t ality and Morbidity (ALERT) intervention, which combined co-design, training, quality improvement and leadership mentoring of maternity units’ heads addressing high perinatal mortality and morbidity in Benin, Malawi, Tanzania and Uganda. ALERT was implemented to promote essential practices of intrapartum childbirth and evaluated using a stepped-wedge cluster-randomized trial with five six-month periods across 16 hospitals. Primary outcomes were in-facility fresh stillbirths and the composite indicator of early perinatal mortality (fresh stillbirth and 24-hour neonatal mortality). Secondary outcomes were hypoxic-ischemic events (Apgar score <7), Cesarean section rate, responsiveness, and respectful care. We estimated separate hospital-specific mixed-effects regression models for binary outcomes and continuous variables to account for heterogeneity across hospitals and countries. All models included treatments status, time period, and random intercepts for randomization groups. We combined effects across hospitals using random-effects meta-analysis with the DerSimonian-Laird estimator. Among 134,630 women (139,300 neonates), the intervention was associated with 12% lower odds of fresh stillbirth (adjusted odds ratio AOR 0.88, 95% CI 0.68-1.13) and 22% lower odds of the composite outcome early perinatal mortality (AOR 0.78, 95% CI 0.65-0.94). The odds of hypoxic-ischemic events were reduced by 19% (AOR 0.81, 95% CI 0.69-0.95). Cesarean section rates increased (AOR 1.14 95% CI 1.01-1.27). We saw no statistically significant effects on our responsiveness or respectfulness measurements. The observed reduction in early perinatal mortality and morbidity underscores the value of investing in routine intrapartum care and multi-faceted interventions supporting context-specific strategies to build maternity provider capacities. (Funded through European Union No 847824, PACTR registration number 202006793783148)