Antenatal Dexamethasone for Early Preterm Birth in Low-Resou
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The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. A multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth was conducted.

The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection. Neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale.

A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants in the dexamethasone group and in 331 of 1406 infants in the placebo group. Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants and in 444 of 1519 fetuses and infants, respectively. The incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively. There was no significant between-group difference in the incidence of adverse events.

Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2022398
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