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© The Author(s). 2016. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

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.

Details

Title
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
Author
Semrau, Katherine E. A. 1 ; Hirschhorn, Lisa R. 1 ; Kodkany, Bhala 2 ; Spector, Jonathan M. 3 ; Tuller, Danielle E. 4 ; King, Gary 5 ; Lipsitz, Stuart 6 ; Sharma, Narender 7 ; Singh, Vinay Pratap 7 ; Kumar, Bharath 7 ; Dhingra-Kumar, Neelam 8 ; Firestone, Rebecca 9 ; Kumar, Vishwajeet 10 ; Gawande, Atul A. 4 

 Ariadne Labs/Harvard Medical School, Boston, USA 
 JNMC Medical College, Belgaum, India (GRID:grid.414956.b) (ISNI:0000 0004 1765 8386) 
 Novartis Institutes for BioMedical Research, Cambridge, USA (GRID:grid.418424.f) (ISNI:0000000404392056) 
 Ariadne Labs/Harvard T.H. Chan School of Public Health, Boston, USA (GRID:grid.189504.1) (ISNI:0000 0004 1936 7558) 
 Harvard University, Cambridge, USA (GRID:grid.38142.3c) (ISNI:000000041936754X) 
 Brigham and Women’s Hospital, Boston, USA (GRID:grid.62560.37) (ISNI:0000000403788294) 
 Population Services International, Lucknow, India (GRID:grid.497579.1) 
 World Health Organization, Geneva 27, Switzerland (GRID:grid.3575.4) (ISNI:0000000121633745) 
 Population Services International, Washington, USA (GRID:grid.423224.1) (ISNI:0000000100203631) 
10  Community Empowerment Lab, Lucknow, India (GRID:grid.423224.1) 
Pages
576
Publication year
2016
Publication date
Dec 2016
Publisher
BioMed Central
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2795253131
Copyright
© The Author(s). 2016. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.