Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)—a stepped wedge cluster randomized controlled trial in public hospitals

Abstract

Background Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package—Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)—on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. Methods We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. Discussion With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. Trial registration number ISRCTN16741720 . Registered on 2 March 2019.

Effect of the COVID-19 pandemic response on intrapartum care, stillbirth, and neonatal mortality outcomes in Nepal: a prospective observational study

“…The improvements observed in hand hygiene practices during childbirth reflect hospital COVID-19 interventions to prevent transmission of SARS-CoV-2 among health-care providers. 16 , 26…”

“…30 The improvement in the health workers' practice of intrapartum fetal heart rate monitoring and breastfeeding within 1 h of birth after a sudden decrease before and during the initial phase of lockdown, followed by a later increase, can be attributed to the ongoing quality improvement initiatives of the SUSTAIN and REFINE studies in these hospitals. 16 …”

“…This is a prospective, observational study nested within two quality improvement studies, REFINE (ISRCTN16741720) and SUSTAIN (ISRCTN18148368), being done in nine health institutions in Nepal to implement a safer birth bundle package for 24 months (from January, 2019, to December, 2020; appendix 3 p 3 ). 16 We report data over a period of 5 months including 12·5 weeks before lockdown implementation (Jan 1–March 20, 2020) and 9·5 weeks during lockdown (March 21–May 30, 2020).…”

“…The annual number of births in these nine hospitals covered 11·2% of the national number of births for 2019. 16 The hospitals in the study provided referral obstetric services through Comprehensive and Emergency Obstetrics and Neonatal Care services. All vaginal births took place in delivery units and caesarean births took place in operating theatres.…”

The use of the PARIHS framework in implementation research and practice—a citation analysis of the literature

“…In these articles, the analysis was performed in different ways, primarily through mapping and comparing PARIHS to other frameworks or models or even policies, but also for general discussions on implementation and evidence-based practice. Among the 185 articles that reported using the PARIHS framework in the analysis, there were also 22 protocols where authors reported that the intention was to use the framework in the analysis [23][24][25][26][27][28][29][30][31][32][33][34][35][47][48][49][50][51][52][53][54][55].…”