Betamethasone falls short of reducing neonatal respiratory complications

Administering betamethasone in the late preterm period to pregnant women at risk of delivering prematurely does not appear to reduce the risk of neonatal respiratory distress, according to a study.

The single-centre, triple-blind, randomized, placebo-controlled trial included 847 pregnant participants at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. These participants were randomly assigned to receive either one course of intramuscular betamethasone (n=423) or placebo (n=424).

The primary endpoint was a composite of treatment for respiratory distress in the neonate, defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life. Secondary outcomes included transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, hypoglycaemia, stillbirth, and early neonatal death. Maternal outcomes such as chorioamnionitis, postpartum haemorrhage, puerperal fever, and length of hospitalization were also assessed.

Enrolment was stopped for futility after the planned interim analysis. Twenty-two participants were lost to follow-up. In the intention-to-treat population, the primary outcome did not significantly differ between the betamethasone group and the placebo group (4.9 percent vs 4.8 percent; relative risk, 1.03, 95 percent confidence interval, 0.57–1.84; number needed to treat, 786).

Secondary neonatal and maternal outcomes were also similar between the two treatment groups.