New England Journal of Medicine · 2025 · 21 citations · 19 references
Public HealthMaternal HealthObstetricsMaternal Health EducationMaternal MortalityNeonatal HealthAntenatal CareBirth CareMaternal Health PreventionNeonatal MortalityNeonatal OutcomesPerinatal MortalityNeonatal Mortality ReductionPerinatal Death RatePerinatal Morbidity ReductionPerinatal Mortality PreventionPerinatal Quality ImprovementPrimary Outcome AnalysisRelative Risk ReductionStepped-wedge Designs
BACKGROUND: Birth-related mortality is a major contributor to the burden of deaths worldwide, especially in low-income countries. The Safer Births Bundle of Care program is a combination of interventions developed to improve the quality of care for mother and baby with the goal of reducing birth-related mortality. METHODS: We performed a 3-year stepped-wedge cluster-randomized study of the Safer Births program at 30 high-burden facilities in five regions in Tanzania. The bundle of interventions in the program was aimed at continuous quality improvement through regular onsite simulation-based training, the collection and use of local clinical data, the assistance of trained local facilitators, and the use of innovative tools for perinatal care. The primary outcome was perinatal death, which included intrapartum stillbirth (suspected death during labor) and neonatal death within the first 24 hours after birth. RESULTS: A total of 281,165 mothers and 277,734 babies were included in the final analysis. The estimated incidence of perinatal death decreased from 15.3 deaths per 1000 births in the baseline period of the program to 12.5 deaths per 1000 births after implementation (adjusted relative risk, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P = 0.001), with substantial heterogeneity among regions. The incidence of intrapartum stillbirths was 8.6 deaths per 1000 births in the baseline period and 8.7 deaths per 1000 births after implementation (adjusted relative risk, 1.01; 95% CI, 0.87 to 1.17), and the incidence of neonatal deaths within the first 24 hours after birth was 6.4 and 3.9 deaths per 1000 births, respectively (adjusted relative risk, 0.61; 95% CI, 0.49 to 0.77). No serious adverse events were reported. CONCLUSIONS: Implementation of the Safer Births Bundle of Care program showed the feasibility of integrating quality-improvement efforts targeting birth-related emergencies in resource-limited settings and was associated with a significant reduction in perinatal mortality. (Funded by the Global Financing Facility; ISRCTN Registry number, ISRCTN30541755.).
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