article · New England Journal of Medicine
Birth-related mortality remains a severe challenge globally, particularly within low-income settings. A three-year stepped-wedge cluster-randomised study evaluated the Safer Births Bundle of Care programme across thirty high-burden facilities situated in five regions of Tanzania. The intervention integrated continuous quality improvement using regular onsite simulation training, local clinical data utilisation, trained local facilitators, and innovative perinatal care tools. Analysing 281,165 mothers and 277,734 newborns, the study found overall perinatal mortality fell from 15.3 deaths per 1,000 births at baseline to 12.5 deaths per 1,000 births post-implementation. Neonatal deaths occurring within the first 24 hours declined sharply from 6.4 to 3.9 deaths per 1,000 births, although intrapartum stillbirth rates showed no significant change. The results demonstrate that implementing structured quality-improvement bundles during birth emergencies is feasible and effective in resource-limited health facilities.
Birth-related deaths represent a high burden in resource-constrained environments. By demonstrating that an integrated package of simulation training, local data tracking, and specialised tools can be rolled out across dozens of hospitals, this research proves that hospital-level quality improvement can substantially increase newborn survival in low-income healthcare systems.
The programme represents an applied and tested clinical package consisting of simulation-based training protocols, data monitoring routines, and innovative perinatal care tools. Potential users include hospital administrators, healthcare providers, and regional public health systems seeking scalable maternal and child health interventions. While proven in real-world facilities, widespread adoption would require operational partnerships with healthcare authorities and deployable tool packages.
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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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DOI: 10.1056/nejmoa2406295
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