The effects of betamethasone in increasing survival rate and respiratory distress of infants born at 34-36 weeks of gestation (late preterm) were investigated. A total of 17 university-based clinical centers were selected and women with a singleton pregnancy at 34 weeks + 0 days to 36 weeks +5 days of gestation with a high probability of late preterm delivery were selected. Women were not eligible for the study if they had received antenatal glucocorticoids at all during her pregnancy or if the patient was expected to go into labor in less than 12 hours.
The treatment of patients followed a strict protocol, and placebos were randomly assigned. Women either received a course of two intramuscular injections of 12 mg betamethasone or a matching placebo, 24 hours apart. The participants and the investigators were both unaware of the treatment and study group assignments. If delivery did not occur, patients were discharged if they were assessed to be stable, and for women who were suspected to go into preterm delivery at that time, labor inductions and C-sections were scheduled accordingly. Outcomes analyzed for this study were the need for respiratory infant support 72 hours after birth and the use of a continuous positive airway pressure cannula to assist with breathing.
It was found that administration of betamethasone decreased the risk for substantial respiratory assistance in infants born late preterm. The rate of the primary outcome, respiratory support, was lower in the betamethasone group than in the placebo group by about 4%. Serious maternal adverse events occurred in 10 women.
In a study such as this one, administering a drug to pregnant women who have high chance of an early delivery or complications can be dangerous. I found it shocking that there were no pharmacists listed as an author or contributor to this study. As I read this article, I was consistently drawn back to how these medical professionals handled patient care, since having a high risk pregnancy is extremely scary for some women. While pregnant, taking a drug whose effects are still being studied is probably even more unsettling.
NEJM. 2016;1-10. Link to Article