Effect of a quality improvement package for intrapartum and immediate newborn care on fresh stillbirth and neonatal mortality among preterm and low-birthweight babies in Kenya and Uganda: a cluster-randomised facility-based trial

Abstract

Summary Background Although gains in newborn survival have been achieved in many low-income and middle-income countries, reductions in stillbirth and neonatal mortality have been slow. Prematurity complications are a major driver of stillbirth and neonatal mortality. We aimed to assess the effect of a quality improvement package for intrapartum and immediate newborn care on stillbirth and preterm neonatal survival in Kenya and Uganda, where evidence-based practices are often underutilised. Methods This unblinded cluster-randomised controlled trial was done in western Kenya and eastern Uganda at facilities that provide 24-h maternity care with at least 200 births per year. The study assessed outcomes of low-birthweight and preterm babies. Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention group or the control group. All facilities received maternity register data strengthening and a modified WHO Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. Liveborn or fresh stillborn babies who weighed between 1000 g and 2500 g, or less than 3000 g with a recorded gestational age of less than 37 weeks, were included in the analysis. We abstracted data from maternity registers for maternal and birth outcomes. Follow-up was done by phone or in person to identify the status of the infant at 28 days. The primary outcome was fresh stillbirth and 28-day neonatal mortality. This trial is registered with ClinicalTrials.gov , NCT03112018 . Findings Between Oct 1, 2016, and April 30, 2019, 20 facilities were randomly assigned to either the intervention group (n=10) or the control group (n=10). Among 5343 eligible babies in these facilities, we assessed outcomes of 2938 newborn and fresh stillborn babies (1447 in the intervention and 1491 in the control group). 347 (23%) of 1491 infants in the control group were stillborn or died in the neonatal period compared with 221 (15%) of 1447 infants in the intervention group at 28 days (odds ratio 0·66, 95% CI 0·54–0·81). No harm or adverse effects were found. Interpretation Fresh stillbirth and neonatal mortality among low-birthweight and preterm babies can be decreased using a package of interventions that reinforces evidence-based practices and invests in health system strengthening. Funding Bill & Melinda Gates Foundation.

Effect of collaborative quality improvement on stillbirths, neonatal mortality and newborn care practices in hospitals of Telangana and Andhra Pradesh, India: evidence from a quasi-experimental mixed-methods study

“…hand washing techniques, the programme did not envisage training on new clinical practices, such as antenatal corticosteroid administration. Recent evaluations of QICs for newborn outcome improvement point to the importance of combining QI with problem analysis and clinical training [ 17 ]. The limited coherence between analysis of drivers of hospital mortality and selection of EBPs, the limited focus on EBPs requiring clinical practice changes and the emphasis on single EBPs as opposed to a whole change package of clinical and non-clinical interventions for the key driver of mortality in each hospital may partly explain the nil results.…”

“…Collaboration between teams can shorten the time required to identify challenges to EBP implementation and can provide an external stimulus for innovative problem-solving [ 13 ]. Evidence on QICs effectiveness is mixed [ 14 , 15 ] and of variable quality [ 14 , 16 ], but recent robust studies reported positive results for newborn health outcomes [ 17 ]. SCSL developed a collaborative of all hospitals empanelled into a government-sponsored health insurance scheme covering care for severely sick newborns: the Aarogyasri Health Care Trust [ 18 ] and the Dr Nandamuri Taraka Rama Rao Vaidya Seva in Telangana and Andhra Pradesh, respectively.…”

Implementing an intrapartum package of interventions to improve quality of care to reduce the burden of preterm birth in Kenya and Uganda

“…The PTBi CRCT yielded significant results—a 34% reduction in the odds of combined fresh stillbirth and neonatal mortality among eligible neonates in the intervention facilities, relative to the control facilities [ 17 ]. Understanding the implementation process by which this was achieved is critical.…”

“…Intervention sites received additional mentorship and support of these two interventions through synergies with PRONTO simulation and team training and QI Collaborative components. A summary graphic describing the package by arm can be found elsewhere [ 17 ].…”

“…The East Africa Preterm Birth Initiative (PTBi-EA) addressed the complexity of QoC by implementing a multi-component intrapartum and immediate newborn care quality improvement package in rural facilities in Kenya and Uganda, between 2016 and 2019. The primary results of this cluster randomized control trial (CRCT) found a 0.66 odds ratio (CI, 0.54–0.81) for the combined primary outcome indicator of fresh stillbirths and 28-day mortality among eligible infants [ 17 ]. This paper aims to describe the implementation of the intervention package in detail using the TIDieR framework [ 15 ].…”