Abstract
OBJECTIVE: To assess the effect of the Safer Baby Bundle (SBB) of care in reducing perinatal mortality in Ethiopia. DESIGN: A quasi-experimental study design was implemented from February to August 2024. The intervention group received the five SBB care package adapted for Ethiopia; improving detection and management of fetal growth restriction, raising awareness and improving care for women with decreased fetal movements, improving awareness of maternal safe going-to-sleep position, improving decision-making about timing of birth for women with risk factors for stillbirth and effective fetal monitoring during labour, and the control group received the standard care. Log-binomial regression analysis was performed to compare the outcome variables. SETTING: Four hospitals in North Shewa Zone, Ethiopia. PARTICIPANTS: 841 women attending antenatal care were included. OUTCOME MEASURES: Stillbirth is the death of a baby before or during birth after 28 weeks of gestation in singleton pregnancies without lethal fetal congenital anomalies, whereas, early neonatal death is the death of a newborn occurring before hospital discharge. RESULTS: In this study, the overall stillbirth rate decreased by 24.8%, from 28.6 to 21.5 per 1000 live births, and neonatal mortality reduced by 19.9%, from 35.7 to 28.6 per 1000 live births, although these results were not statistically significant. Additionally, the intervention significantly reduced the incidence of non-reassuring fetal heart rate patterns during labour (adjusted risk ratio (aRR)=0.78, 95% CI 0.64 to 0.95), low birth weight (aRR=0.77, 95% CI 0.60 to 0.98) and the need for neonatal resuscitation (aRR=0.59, 95% CI 0.37 to 0.94). However, there was a concurrent increase in neonatal intensive care unit admissions (aRR=1.42, 95% CI 1.19 to 1.69). CONCLUSION: The implementation of the SBB, adapted for Ethiopia, was associated with improvements in perinatal health outcomes. Further implementation research to identify causal effects and assess feasibility in Ethiopia and other low-income and middle-income countries is crucial. TRIAL REGISTRATION NUMBER: https://pactr.samrc.ac.za, PACTR202503889654904.