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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
- Source :
- Trials
- Publication Year :
- 2016
-
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. 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.
- Subjects :
- Quality management
Time Factors
Health Status
Maternal Health
Medicine (miscellaneous)
Severity of Illness Index
law.invention
Study Protocol
Supportive supervision
0302 clinical medicine
Randomized controlled trial
Clinical Protocols
law
Pregnancy
Risk Factors
Infant Mortality
Childbirth
Pharmacology (medical)
030212 general & internal medicine
education.field_of_study
030219 obstetrics & reproductive medicine
Delivery of Health Care, Integrated
Behavior change
Stillbirth
Coaching
Checklist
Maternal Mortality
Research Design
Maternal death
Female
Cluster-randomized controlled trial
Population
India
WHO Safe Childbirth Checklist
Disease cluster
World Health Organization
Risk Assessment
03 medical and health sciences
Nursing
medicine
Humans
Infant Health
Maternal Health Services
Newborn health
Quality improvement
education
Fetal Death
Quality Indicators, Health Care
Patient Care Team
business.industry
Infant, Newborn
Infant
Mentoring
medicine.disease
Perinatal health
Pregnancy Complications
Leadership
business
Program Evaluation
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 17
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....e2e12975bd91e550a769ca2970e1b519