Delhi: The use of dexamethasone in women at high risk for early preterm birth helps in significant lowering of neonatal deaths, suggests a recent study in the New England Journal of Medicine.
Preterm birth is a leading cause of death in infants and children younger than 5 years of age globally.Infants born preterm are also at increased risk for a wide range of short-term and long-term respiratory, infectious, metabolic, and neurologic conditions, with higher risks among those born during the early preterm period.
The researchers determined the safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth.
For the purpose, the researchers conducted 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. They were assigned to intramuscular dexamethasone or an 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 across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for the benefit at the second interim analysis.
Key findings of the study include:
Neonatal death occurred in 19.6% of the infants in the dexamethasone group and in 23.5% infants in the placebo group (relative risk, 0.84).
Stillbirth or neonatal death occurred in 25.7% of fetuses and infants and in 29.2% of fetuses and infants (29.2%), respectively (relative risk, 0.88); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76).
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," concluded the authors.