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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952 ; Universal Trial Number: U1111-1131-5647.
authors.affiliation: Ariadne Labs/Harvard Medical School, 401 Park Drive, 3rd floor East, Boston, MA, 02115, USA. ksemrau@ariadnelabs.org.
authors.forename: Katherine E A
authors.initials: KE
authors.lastname: Semrau
authors.affiliation: Ariadne Labs/Harvard Medical School, 401 Park Drive, 3rd floor East, Boston, MA, 02115, USA.
authors.forename: Lisa R
authors.initials: LR
authors.lastname: Hirschhorn
authors.affiliation: JNMC Medical College, Belgaum, 590010, Karnataka, India.
authors.forename: Bhala
authors.initials: B
authors.lastname: Kodkany
authors.affiliation: Novartis Institutes for BioMedical Research, 250 Massachusetts Avenue, Cambridge, MA, 02138, USA.
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Spector
authors.affiliation: Ariadne Labs/Harvard T.H. Chan School of Public Health, 401 Park Drive, 3rd floor East, Boston, MA, 02115, USA.
authors.forename: Danielle E
authors.initials: DE
authors.lastname: Tuller
authors.affiliation: Harvard University, 1737 Cambridge Street Harvard University, Cambridge, MA, 02138, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: King
authors.affiliation: Brigham and Women's Hospital, 1620 Tremont Street, 4-020, Boston, MA, 02120, USA.
authors.forename: Stuart
authors.initials: S
authors.lastname: Lipsitz
authors.affiliation: Population Services International, 2/325, Vijayant Khand, Gomti Nagar, Lucknow, 226010, Uttar Pradesh, India.
authors.forename: Narender
authors.initials: N
authors.lastname: Sharma
authors.affiliation: Population Services International, 2/325, Vijayant Khand, Gomti Nagar, Lucknow, 226010, Uttar Pradesh, India.
authors.forename: Vinay Pratap
authors.initials: VP
authors.lastname: Singh
authors.affiliation: Population Services International, 2/325, Vijayant Khand, Gomti Nagar, Lucknow, 226010, Uttar Pradesh, India.
authors.forename: Bharath
authors.initials: B
authors.lastname: Kumar
authors.affiliation: World Health Organization, 20, Avenue Appia, 1211, Geneva 27, Switzerland.
authors.forename: Neelam
authors.initials: N
authors.lastname: Dhingra-Kumar
authors.affiliation: Population Services International, 1120 19th Street, NW, Suite 600, Washington, DC, 20036, USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Firestone
authors.affiliation: Community Empowerment Lab, 26/11 Wazeer Hassan Road, Lucknow, 226001, India.
authors.forename: Vishwajeet
authors.initials: V
authors.lastname: Kumar
authors.affiliation: Ariadne Labs/Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA.
authors.forename: Atul A
authors.initials: AA
authors.lastname: Gawande
mesh_terms: D057189:Checklist; D002985:Clinical Protocols; D019033:Delivery of Health Care, Integrated / Q000458:organization & administration*; D005260:Female; D005313:Fetal Death / Q000209:etiology / Q000517:prevention & control; D006304:Health Status; D006801:Humans; D007194:India; D007223:Infant; D000068104:Infant Health; D007226:Infant Mortality; D007231:Infant, Newborn; D007857:Leadership; D000068097:Maternal Health; D008427:Maternal Health Services / Q000458:organization & administration*; D008428:Maternal Mortality; D000071252:Mentoring; D010348:Patient Care Team / Q000458:organization & administration*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D015397:Program Evaluation; D058996:Quality Improvement; D019984:Quality Indicators, Health Care; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D014944:World Health Organization
keywords: Cluster-randomized controlled trial; Coaching; India; Maternal health; Newborn health; Perinatal health; Quality improvement; Stillbirth; Supportive supervision; WHO Safe Childbirth Checklist