Abstract
BackgroundEach 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.MethodsWe 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.DiscussionWith 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 numberISRCTN16741720. Registered on 2 March 2019.
Highlights
Each year, 2.2 million intrapartum-related deaths occur worldwide with 99% of them taking place in low- and middle-income countries
The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal
The accelerated reduction in maternal and child mortality during the Millennium Development Goal era (2000– 2015) led to the realization that further reduction can only be achieved with improved quality of care in the intrapartum period [1, 2]
Summary
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. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. The accelerated reduction in maternal and child mortality during the Millennium Development Goal era (2000– 2015) led to the realization that further reduction can only be achieved with improved quality of care in the intrapartum period [1, 2]. The United Nations’ Every Woman and Every Child strategy 2016–2030 aims to reduce preventable maternal, neonatal, and child deaths by the end of the Sustainable Development period 2030 [6]. Its five foundations are (1) understanding populations’ health care needs; (2) strengthening structures and governance for improving quality of care at all levels of health systems [11]; (3) redesigning and optimizing the health workforce to provide a more conducive environment for health care provision; (4) introducing new tools, quality improvement interventions, and technologies for delivering health care; and (5) the adequacy or capacity of health facilities to deliver health care as per the demands of their client populations [8]
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