Effects of the World Health Organization Safe Childbirth Checklist on Quality of Care and Birth Outcomes in Aceh, Indonesia: A Cluster-Randomized Clinical Trial.

Importance: To address major causes of perinatal and maternal mortality, the World Health Organization developed the Safe Childbirth Checklist (SCC), which to our knowledge has been rigorously evaluated only in combination with high-intensity coaching. Objective: To evaluate the effect of the SCC with medium-intensity coaching on health care workers' performance of essential birth practices. Design, Setting, and Participants: This cluster randomized clinical trial without blinding included 32 hospitals and community health centers in the province of Aceh, Indonesia (a medium-resource setting) that met the criterion of providing at least basic emergency obstetric and newborn care. Baseline data were collected from August to October 2016, and outcomes were measured from March to April 2017. Data were analyzed from January 2020 to October 2021. Interventions: After applying an optimization method, facilities were randomly assigned to the treatment or control group (16 facilities each). The SCC with 11 coaching visits was implemented during a 6-month period. Main Outcomes and Measures: For the primary outcome, clinical observers documented whether 36 essential birth practices were applied at treatment and control facilities at 1 or more of 4 pause points during the birthing process (admission to the hospital, just before pushing or cesarean delivery, soon after birth, and before hospital discharge). Probability models for binary outcome measures were estimated using ordinary least-squares regressions, complemented by Firth logit and complier average causal effect estimations. Results: Among the 32 facilities that participated in the trial, a significant increase of up to 41 percentage points was observed in the application of 5 of 36 essential birth practices in the 16 treatment facilities compared with the 16 control facilities, including communication of danger signs at admission (treatment: 136 of 155 births [88%]; control: 79 of 107 births [74%]), measurement of neonatal temperature (treatment: 9 of 31 births [29%]; control: 1 of 20 births [5%]), newborn feeding checks (treatment: 22 of 34 births [65%]; control: 5 of 21 births [24%]), and the rate of communication of danger signs to mothers and birth companions verbally (treatment: 30 of 36 births [83%]; control: 14 of 22 births [64%]) and in a written format (treatment: 3 of 24 births [13%]; control: 0 of 16 births [0%]). Conclusions and Relevance: In this cluster randomized clinical trial, health facilities that implemented the SCC with medium-intensity coaching had an increased rate of application for 5 of 36 essential birth practices compared with the control facilities. Medium-intensity coaching may not be sufficient to increase uptake of the SCC to a satisfying extent, but it may be worthwhile to assess a redesigned coaching approach prompting long-term behavioral change and, therefore, effectiveness. Trial Registration: isrctn.org Identifier: ISRCTN11041580.