Antenatal dexamethasone reduces risk of neonatal death among women in low-resource countries without an increase in maternal bacterial infection

Study design: Randomised controlled trial.

Allocation: Computer-generated randomisation sequence.

Binding: Double-blind, parallel group.

Setting: 29 secondary and tertiary level hospitals across Nigeria, Kenya, India, Bangladesh and Pakistan.

Patients: Women with a gestational age between 26 weeks and 0 days and 33 weeks and 6 days of gestation with risk of preterm birth within next 48 hours were included. Exclusion criteria were women with severe infection, major congenital malformations and, concurrent or recent use of systemic glucocorticoids.

Intervention: In ratio of 1:1, a course of 6 mg intramuscular dexamethasone or placebo administered every 12 hours for four doses.

Outcomes: The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection. Secondary outcomes included neonatal and maternal mortality and morbidity.

Follow-up: 28 …

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