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

Lancet Glob Health. 2020 Aug;8(8):e1061-e1070. doi: 10.1016/S2214-109X(20)30232-1.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Female
  • Humans
  • Infant
  • Infant Mortality / trends*
  • Infant, Low Birth Weight*
  • Infant, Newborn
  • Infant, Premature*
  • Kenya / epidemiology
  • Male
  • Maternal-Child Health Services / organization & administration*
  • Pregnancy
  • Quality Improvement / organization & administration*
  • Stillbirth / epidemiology*
  • Uganda / epidemiology

Associated data

  • ClinicalTrials.gov/NCT03112018