Research Article: Effect of a scaled-up neonatal resuscitation quality improvement package on intrapartum-related mortality in Nepal: A stepped-wedge cluster randomized controlled trial

Date Published: September 9, 2019

Publisher: Public Library of Science

Author(s): Ashish KC, Uwe Ewald, Omkar Basnet, Abhishek Gurung, Sushil Nath Pyakuryal, Bijay Kumar Jha, Anna Bergström, Leif Eriksson, Prajwal Paudel, Sushil Karki, Sunil Gajurel, Olivia Brunell, Johan Wrammert, Helena Litorp, Mats Målqvist, Mark Tomlinson

Abstract: BackgroundImproving quality of intrapartum care will reduce intrapartum stillbirth and neonatal mortality, especially in resource-poor settings. Basic neonatal resuscitation can reduce intrapartum stillbirth and early neonatal mortality, if delivered in a high-quality health system, but there is a dearth of evidence on how to scale up such evidence-based interventions. We evaluated the scaling up of a quality improvement (QI) package for neonatal resuscitation on intrapartum-related mortality (intrapartum stillbirth and first day mortality) at hospitals in Nepal.Methods and findingsWe conducted a stepped-wedge cluster randomized controlled trial in 12 hospitals over a period of 18 months from April 14, 2017, to October 17, 2018. The hospitals were assigned to one of four wedges through random allocation. The QI package was implemented in a stepped-wedge manner with a delay of three months for each step. The QI package included improving hospital leadership on intrapartum care, building health workers’ competency on neonatal resuscitation, and continuous facilitated QI processes in clinical units. An independent data collection system was set up at each hospital to gather data on mortality through patient case note review and demographic characteristics of women using semi-structured exit interviews. The generalized linear mixed model (GLMM) and multivariate logistic regression were used for analyses. During this study period, a total of 89,014 women–infant pairs were enrolled. The mean age of the mother in the study period was 24.0 ± 4.3 years, with 54.9% from disadvantaged ethnic groups and 4.0% of them illiterate. Of the total birth cohort, 54.4% were boys, 16.7% had gestational age less than 37 weeks, and 17.1% had birth weight less than 2,500 grams. The incidence of intrapartum-related mortality was 11.0 per 1,000 births during the control period and 8.0 per 1,000 births during the intervention period (adjusted odds ratio [aOR], 0.79; 95% CI, 0.69–0.92; p = 0.002; intra-cluster correlation coefficient [ICC], 0.0286). The incidence of early neonatal mortality was 12.7 per 1,000 live births during the control period and 10.1 per 1,000 live births during the intervention period (aOR, 0.89; 95% CI, 0.78–1.02; p = 0.09; ICC, 0.1538). The use of bag-and-mask ventilation for babies with low Apgar score (<7 at 1 minute) increased from 3.2% in the control period to 4.0% in the intervention period (aOR, 1.52; 95% CI, 1.32–1.77, p = 0.003). There were two major limitations to the study; although a large sample of women–infant pairs were enrolled in the study, the clustering reduced the power of the study. Secondly, the study was not sufficiently powered to detect reduction in early neonatal mortality with the number of clusters provided.ConclusionThese results suggest scaled-up implementation of a QI package for neonatal resuscitation can reduce intrapartum-related mortality and improve clinical care. The QI intervention package is likely to be effective in similar settings. More implementation research is required to assess the sustainability of QI interventions and quality of care.Trial registrationISRCTN30829654.

Partial Text: Achieving Sustainable Development Goal (SDG) 3.2, to reduce global neonatal mortality to 12 per 1,000 live births by 2030, will require transformative changes in healthcare systems, with increased efforts to deliver high-quality services [1,2,3,4]. In the last 20 years, significant investment has been made to improve the behavior of communities when it comes to seeking pregnancy and delivery care at health institutions [5, 6]. As a result, globally, in 2018, almost 59% of women received all four antenatal checkups, and 75% of women were delivered by a skilled provider [7]. However, health institutions have not been able to step up the pace in delivering high-quality and trustworthy care to women and families [8]. In the SDG era, a healthcare system consistently delivering optimal and consistent healthcare remains to be a centerpiece, not only to accelerate the momentum for improving health outcomes but also to garner trust through positive user experience [9, 10]. In 2017, poor quality of care accounted for almost 1 million neonatal deaths, mostly during the intrapartum period [11]. Improving care during labor and birth will have the highest impact on survival, as it is the period of highest risk to mothers and newborns, with almost 2.2 million intrapartum-related mortality occurring during this period every year [12,13].

This study is reported as per the Consolidated Standards of Reporting Trials (CONSORT) guideline (S1 CONSORT Checklist).

A total of 92,322 women were eligible to be included in the study in the primary ITT analysis. Of these, 3,808 women were excluded, as they were referred to other facilities for delivery or declined to participate in the study. This resulted in 88,524 deliveries being recorded during the 18-month study period (Fig 2).

Results indicate that scaling up a package of QI interventions for improved intrapartum survival is feasible and also has the potential to increase the quality of care in real-life settings. We observed effects in clinical practice, as bag-and-mask ventilation for babies and suctioning increased. However, not all hospitals included in the trial displayed the same process and results, testifying to the diversity of contexts and conditions of scaled-up efforts. Further analyses to understand the contextual implications are needed.



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