Outcomes of implementing a coaching-based WHO Safe Childbirth Checklist program in India

BACKGROUND: Facility-based childbirth in low-resource settings has increased dramatically over the last two decades, yet quality of care gaps persist and mortality rates remain high. The World Health Organization (WHO) Safe Childbirth Checklist, a quality improvement tool, promotes systematic adherence to practices known to save lives and prevent harm during childbirth. METHODS: We conducted a matched-pair, cluster-randomized controlled trial in 60 pairs o facilities across 24 districts of Uttar Pradesh, India to test the effectiveness of the BetterBirth program, an 8-month coaching-based implementation of the Checklist, on a composite outcome of 7-day maternal/perinatal mortality and maternal morbidity. Outcomes—assessed 8-42 days post-partum—were compared between study arms adjusting for clustering and matching. We also compared birth attendants’ mean adherence to 18 essential birth practices in 15 matched pairs of facilities at 2 and 12 months after intervention initiation. RESULTS: Of 161,107 eligible women, we enrolled 157,689 (98%) and determined 7-day outcomes for 157,145 (99.7%) mother-newborn dyads. Of 4888 observed births, birth attendants’ adherence to practices was significantly higher in the intervention (I) than control (C) arm (I: 73% vs. C: 42% at 2 months, p≤0.01; I: 62% vs. C: 44% at 12 months, p≤0.01). However, we found no difference in the composite outcome (I: 15.1% C: 15.3%, RR: 0.99, 95% CI: 0.83-1.18, p=0.90). CONCLUSION: The coaching-based WHO Safe Childbirth Checklist program produced increased adherence to some essential birth practices, but did not reduce morbidity and mortality. (Clinical Trials #NCT02148952; The Bill & Melinda Gates Foundation)