The impact of the Antenatal Late Preterm Steroids trial on the administration of antenatal corticosteroids

Abstract

Background: In 2016 the Antenatal Late Preterm Steroids study was published, demonstrating that antenatal corticosteroid therapy given to women at risk of late preterm delivery reduces respiratory morbidity in infants. However, the administration of antenatal corticosteroid therapy in late-preterm infants remains controversial. Late-preterm infants do not suffer from the same rates of morbidity as early-preterm infants, and the short-term benefits of antenatal corticosteroid therapy are less pronounced; consequently, the risk of possible harm is more difficult to balance.

Objective: This study aimed to evaluate the association between the publication of the Antenatal Late Preterm Steroids study or the subsequent changes in guidelines and the rates of antenatal corticosteroid therapy administration in late-preterm infants in the United States.

Study design: Data analyzed were publicly available US birth certificate data from January 1, 2016 to December 31, 2018. An interrupted time series design was used to analyze the association between publication of the Antenatal Late Preterm Steroids study and changes in monthly rates of antenatal corticosteroid administration in late preterm gestation (34+0 to 36+6 weeks). Births at 28+0 to 31+6 weeks' gestation were used as a control. Antenatal corticosteroid therapy administration in women with births at 32+0 to 34+6 weeks was explored to analyze whether the intervention influenced antenatal corticosteroid therapy administration in women in the subgroup approaching 34 weeks' gestation. Antenatal corticosteroid therapy administration in women with term births (>37 weeks' gestation) was analyzed to explore if the intervention influenced the number of term babies exposed to antenatal corticosteroid therapy. Our regression model allowed analysis of both step and slope changes. February 2016 was chosen as the intervention period.

Results: Our sample size was 18,031,950 total births. Of these, 1,056,047 were births at 34+0 to 36+6 weeks' gestation, 123,788 at 28+0 to 31+6 weeks, 153,708 at 32 to 33 weeks, and 16,602,699 were term births. There were 95,708 births at <28 weeks' gestation. There was a statistically significant increase in antenatal corticosteroid therapy administration rates in late preterm births following the online publication of the Antenatal Late Preterm Steroids study (adjusted incidence rate ratio, 1.48; 95% confidence interval, 1.36-1.61; P=.00). A significant increase in antenatal corticosteroid therapy administration rates was also seen in full-term births following the online publication of the Antenatal Late Preterm Steroids study. No significant changes were seen in antenatal corticosteroid administration rates in gestational age groups of 32+0 to 33+6 weeks or 28+0 to 31+6 weeks.

Conclusion: Online publication of the Antenatal Late Preterm Steroids study was associated with an immediate and sustained increase in the rates of antenatal corticosteroid therapy administration in late preterm births across the United States, demonstrating a swift and successful implementation of the Antenatal Late Preterm Steroids study guidance into clinical practice. However, there is an unnecessary increase in full-term infants receiving antenatal corticosteroid therapy. Given that the long-term consequences of antenatal corticosteroid therapy are yet to be elucidated, efforts should be made to minimize the number of infants unnecessarily exposed to antenatal corticosteroid therapy.

Keywords: antenatal corticosteroids; late preterm birth; prematurity; steroids; time series analysis.