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dc.contributor.authorSemrau, Katherine E. A.en_US
dc.contributor.authorHirschhorn, Lisa R.en_US
dc.contributor.authorKodkany, Bhalaen_US
dc.contributor.authorSpector, Jonathan M.en_US
dc.contributor.authorTuller, Danielle E.en_US
dc.contributor.authorKing, Garyen_US
dc.contributor.authorLipsitz, Stuarten_US
dc.contributor.authorSharma, Narenderen_US
dc.contributor.authorSingh, Vinay Pratapen_US
dc.contributor.authorKumar, Bharathen_US
dc.contributor.authorDhingra-Kumar, Neelamen_US
dc.contributor.authorFirestone, Rebeccaen_US
dc.contributor.authorKumar, Vishwajeeten_US
dc.contributor.authorGawande, Atul A.en_US
dc.date.accessioned2017-01-03T23:50:57Z
dc.date.issued2016en_US
dc.identifier.citationSemrau, K. E. A., L. R. Hirschhorn, B. Kodkany, J. M. Spector, D. E. Tuller, G. King, S. Lipsitz, et al. 2016. “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.” Trials 17 (1): 576. doi:10.1186/s13063-016-1673-x. http://dx.doi.org/10.1186/s13063-016-1673-x.en
dc.identifier.issn1745-6215en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:29739188
dc.description.abstractBackground: 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. 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/design This 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. Discussion If 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 registration BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1673-x) contains supplementary material, which is available to authorized users.en
dc.language.isoen_USen
dc.publisherBioMed Centralen
dc.relation.isversionofdoi:10.1186/s13063-016-1673-xen
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC5142140/pdf/en
dash.licenseLAAen_US
dc.subjectCluster-randomized controlled trialen
dc.subjectWHO Safe Childbirth Checklisten
dc.subjectMaternal healthen
dc.subjectNewborn healthen
dc.subjectPerinatal healthen
dc.subjectStillbirthen
dc.subjectCoachingen
dc.subjectSupportive supervisionen
dc.subjectQuality improvementen
dc.subjectIndiaen
dc.titleEffectiveness 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 trialen
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden
dc.relation.journalTrialsen
dash.depositing.authorSemrau, Katherine E. A.en_US
dc.date.available2017-01-03T23:50:57Z
dc.identifier.doi10.1186/s13063-016-1673-x*
dash.authorsorderedfalse
dash.identifier.orcid0000-0002-5327-7631en_US
dash.contributor.affiliatedTuller, Danielle
dash.contributor.affiliatedHirschhorn, Lisa
dash.contributor.affiliatedSemrau, Katherine
dash.contributor.affiliatedGawande, Atul
dash.contributor.affiliatedKing, Gary
dash.contributor.affiliatedLipsitz, Stuart


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