Effect of meso-and micro-level quality improvement interventions to improve intrapartum care and birth outcome in Nepal- stepped wedge cluster randomized trial

BACKGROUND: High-quality intrapartum care benefits from implementation of quality improvement (QI) interventions. However, scale-up of meso- and micro-level QI interventions to improve health facility performance have shown mixed results in Nepal. OBJECTIVE: This study aims to evaluate the effect of such interventions to intrapartum care and intrapartum mortality (intrapartum stillbirth and first day neonatal death) in public health facilities of Nepal. STUDY DESIGN: A stepped-wedge cluster randomized design was applied to implement the SUSTAIN package, comprising meso- and micro-level QI interventions in 8 hospitals across all provinces of Nepal over a 21-month period. Each hospital had a 2-month window to introduce QI interventions in their governance and clinical processes. Women with gestational age ≥22 weeks were included with research teams established in each hospital to monitor mortality and health workers' performance. For each outcome, hospital-specific incidence rate ratios (IRRs) were estimated by comparing event rates in the intervention period with those in the control period. RESULTS: The study enrolled, 55,325 and 53,578 women were enrolled in the control and intervention periods, respectively. The SUSTAIN package resulted in a statistically non-significant reduction (16%) in intrapartum mortality at the hospital level (IRR 0.84 (95% CI: 0.66, 1.08)), while at the individual level there was also statistically non-significant lower odd (37%) of mortality (aOR: 0.63 (0.38, 1.04), P<.0001)). Improvement in intrapartum care were consistent in most of care indicators with adherence to hand-washing increased by 2.36 fold (IRR 2.36 (95% CI: 1.03, 5.39)), fetal heart-rate monitoring increased by 1.55 fold (IRR 1.55 (95% CI: 1.10, 2.17)), delayed cord clamping increased non-significantly by1.14 fold (IRR 1.14 (95% CI: 0.96, 1.35)), immediate skin-to-skin contact increased by 9.92 fold (IRR 9.92 (95% CI: 3.21, 30.64)), early breastfeeding increased by 4.09 fold (IRR 4.09 (95% CI: 2.07, 8.11)), and bag-and-mask within 1 minute increased by 3.30 fold (IRR 3.30 (95% CI: 2.02, 5.40). CONCLUSION: A synergistic and multi-faceted QI package implementation can improve intrapartum care with a statistically non-significant reduction in intrapartum mortality even during the COVID-19 pandemic. TRIAL: https://doi.org/10.1186/ISRCTN16741720.