Abstract
BackgroundAntenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth. However, the safety and efficacy of ACS in hospitals in low-resource countries has not been established in an efficacy trial despite their widespread use. Findings of a large cluster-randomized trial in six low- and middle-income countries showed that efforts to scale up ACS use in low-resource settings can lead to harm. There is equipoise regarding the benefits and harms of ACS use in hospitals in low-resource countries. This randomized controlled trial aims to determine whether ACS are safe and efficacious when given to women at risk of imminent birth in the early preterm period, in hospitals in low-resource countries.Methods/designThe trial design is a parallel, two-arm, double-blind, individually randomized, placebo-controlled trial of ACS (dexamethasone) for women at risk of imminent preterm birth. The trial will recruit 6018 women in participating hospitals across five low-resource countries (Bangladesh, India, Kenya, Nigeria and Pakistan). The primary objectives are to compare the efficacy of dexamethasone with placebo on survival of the baby and maternal infectious morbidity. The primary outcomes are: 1) neonatal death (to 28 completed days of life); 2) any baby death (any stillbirth postrandomization or neonatal death); and 3) a composite outcome to assess possible maternal bacterial infections. The trial will recruit eligible, consenting pregnant women from 26 weeks 0 days to 33 weeks 6 days gestation with confirmed live fetuses, in whom birth is planned or expected within 48 h. The intervention comprises a regimen of intramuscular dexamethasone sodium phosphate. The comparison is an identical placebo regimen (normal saline). A total of 6018 women will be recruited to detect a reduction of 15% or more in neonatal deaths in a two-sided 5% significance test with 90% power (including 10% loss to follow-up).DiscussionFindings of this trial will guide clinicians, programme managers and policymakers on the safety and efficacy of ACS in hospitals in low-resource countries. The trial findings will inform updating of the World Health Organization’s global recommendations on ACS use.Trial registrationACTRN12617000476336. Registered on 31 March 2017.
Highlights
Antenatal corticosteroids (ACS) have long been regarded as a cornerstone intervention in mitigating the adverse effects of a preterm birth
The primary objectives are to compare the effect of dexamethasone with placebo on stillbirth, neonatal survival and possible maternal bacterial infections when given to women at risk of imminent preterm birth in participating hospitals
The safety and efficacy concerns surrounding use of ACS in hospitals in low- and middle-income countries have arrested efforts to scale-up the use of ACS in these settings
Summary
Preterm birth is an important global public health issue, affecting an estimated 15 million live births worldwide each year [1]. The safety and efficacy concerns surrounding use of ACS in hospitals in low- and middle-income countries have arrested efforts to scale-up the use of ACS in these settings This trial will address key knowledge gaps around efficacy and safety of ACS in low-resource countries, and strengthen the overall evidence base on the efficacy of ACS by doubling the number of participants in the Cochrane review on this topic [23]. It is anticipated that the findings will be generalizable to other, similar hospitals in low- to middle-income countries Results of this trial will be published in a peer-reviewed, open-access journal by the WHO ACTION Trials Collaboration.
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