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.
Highlights
Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries
Rates of adherence by health workers to essential childbirth practices: In a sample of total births, uptake of the following practices will be assessed: maternal temperature obtained on admission, maternal blood pressure obtained on admission, partograph use, appropriate hand hygiene by health workers before 1st vaginal examination, oxytocin administration within 1 minute after birth, appropriate intervention for the newborn if apneic at birth, newborn weight and temperature obtained within 1 hour after birth, and initiation of breastfeeding within 1 hour after birth
The Safe Childbirth Checklist is a World Health Organization (WHO)-branded tool developed by frontline health workers and technical experts in maternal health, newborn health, checklistbased programs, quality improvement, and implementation science [10]
Summary
The Safe Childbirth Checklist is a WHO-branded tool developed by frontline health workers and technical experts in maternal health, newborn health, checklistbased programs, quality improvement, and implementation science [10]. To ensure alignment of the trial with policies and priorities at these levels, we will establish regular channels of formal and informal communication and engagement This includes providing updates on progress and feedback of implementation data, partnering with key figures at each level to hold joint public meetings with national, state, and district leaders to reflect on progress of the program and trial, and providing training to government officials in areas of local interest. We completed several pilot studies in facilities in UP, using a quality improvement methodology, and measured success in both effectiveness of education as well as rates of adoption of the care practices comprising the SCC Through these pilot tests in nine facilities, we progressively modified our approach until we were certain that we had removed all identifiable impediments to successful implementation, data collection, and monitoring [30].
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