Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial

Abstract

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.

Improving Adherence to Essential Birth Practices Using the WHO Safe Childbirth Checklist With Peer Coaching: Experience From 60 Public Health Facilities in Uttar Pradesh, India

“…The methodology of the trial is available elsewhere, 20 and a detailed description of the intervention is published as a companion article in this issue of Global Health: Science and Practice 21 . Impact results on perinatal mortality, maternal mortality, and severe maternal morbidity will be reported elsewhere.…”

“…To support ongoing facility-level adherence to essential practices, a facility staff member was identified and trained to support SCC use after the intervention was completed. The program is described in more detail elsewhere 18 , 20 , 21 . Technical training and supplies were not provided.…”

“…Site selection for the overall trial and batch-wise implementation is described elsewhere 20 . Of the 60 intervention facilities, a pragmatic sample of 15 facilities was selected based on geographic location, in which independent observers recorded birth attendant behavior when coaches were absent.…”

“…Previous studies of the SCC have suggested that peer coaching based on feedback about SCC use, 18 ensuring buy-in from the larger health care system, and integrating the SCC into existing workflows 19 increased the likelihood of making real, sustained improvements in the quality of facility-based childbirth care. The BetterBirth Program—an intervention aiming for sustained SCC adoption through coaching-based implementation—was developed based on lessons learned from early implementations of the SCC and from other quality-improvement projects 20 , 21 …”

Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial

“…First, the WHO developed the Safe Childbirth Checklist which includes 29 EBPs that focus on maternal and neonatal outcomes at four pause points – on admission to the facility, at the time of pushing (or before cesarean delivery), soon after birth (within 1 h) and at discharge. This checklist has been used in a variety of LMICs contexts, including India, Sri Lanka, and Namibia [9–11]. In Namibia, the authors reported an increase of EBPs from 68% to 95% over a 6-month period, as well as a reduction in perinatal mortality from 22 to 13.8 deaths/1000 deliveries [11].…”