Innovation. AS is a member of WHO's Third Global Patient Safety Challenge and chairs its Monitoring and Evaluation Working Group. We declare no other competing interests. The authors alone are responsible for the views expressed in this Comment and they do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated.

BackgroundFacility-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. MethodsWe 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. ResultsOf 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). ConclusionThe 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)

Editorials Editorials 546ABull World Health Organ 2017;95:546-546A | doi: http://dx

(N Engl J Med. 2017;377(24):2313–2324) The Safe Childbirth Checklist, created by the World Health Organization, is a practical tool encompassing a bundle of 28 essential birth practices. In the present study, the authors performed a large cluster-randomized trial of the BetterBirth program, which involves a coaching-based implementation of this checklist, to determine whether or not facility-based birth adherence to this checklist improved evidence-based care. The authors hypothesized that, if implemented at the cluster level, the intervention would reduce the composite outcome of stillbirth, early neonatal death, maternal death, or maternal severe complications during postpartum days 0 to 7.

BackgroundEffective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs). The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs, deaths, and complications at a larger scale.Methods/designThis matched-pair, cluster-randomized controlled, adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh, India. Study sites, identified according to predefined eligibility criteria, were matched by measured covariates before randomization. The intervention, the SCC embedded in a quality improvement program, consists of leadership engagement, a 2-day educational launch of the SCC, and support through placement of a trained peer “coach” to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity. A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility.Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites. The primary outcome is a composite measure including maternal death, maternal severe morbidity, stillbirth, and newborn death, occurring within 7 days after birth. The sample size (n = 171,964) was calculated to detect a 15% reduction in the primary outcome. Adherence by health workers to EBPs will be measured in a subset of births (n = 6000).The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh, the World Health Organization, an expert Scientific Advisory Committee, an experienced local implementing organization (Population Services International, PSI), and frontline facility leaders and workers.DiscussionIf effective, the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns, with millions of potential beneficiaries.Trial registrationBetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1673-x) contains supplementary material, which is available to authorized users.