WHO ACTION Trials

Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns

Project Summary

A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in health facilities in low-resource settings to improve newborn outcomes

An estimated 14·9 million neonates were born preterm in 2010, accounting for 11·1% of live births worldwide. Complications of preterm birth (PTB) are the leading cause of under-5 mortality, and preterm neonates are at increased risk of numerous short- and long-term respiratory, infectious and neurological morbidities. Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of preterm birth. However, there are several important limitations that restrict generalizability of current evidence to ACS use in low- and middle-income countries (LMICs). Furthermore, serious concerns regarding whether ACS are safe and/or effective in low-resource settings have been raised by the recent Antenatal Corticosteroids Trial (ACT).

Study objectives

The aim of this trial is to determine whether antenatal corticosteroids are safe and efficacious for women and newborns in resource-limited settings, when given to women with a live fetus/es at risk of imminent preterm birth from 26 weeks 0 days to 33 weeks 6 days gestation in facilities for the prevention of neonatal deaths.

1. To compare the effect of dexamethasone to placebo on stillbirth and neonatal survival when given to women at risk of imminent preterm birth in facilities.
2. To compare the effect of dexamethasone to placebo on possible maternal bacterial infections when given to women at risk of imminent preterm birth in facilities.

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