Post Antenatal Late Preterm Steroids trial: interrupted time series analysis of respiratory outcomes in twin and pregestational diabetes

Abstract

The Antenatal Late Preterm Steroids trial found that corticosteroid administration decreased respiratory complications by 20% among late preterm singleton deliveries. After the Antenatal Late Preterm Steroids trial, corticosteroid administration increased by 76% among twin pregnancies and 113% among singleton pregnancies complicated by pregestational diabetes mellitus compared with expected rates based on the pre-Antenatal Late Preterm Steroids trial trend. However, the effect of corticosteroids on twin pregnancies and pregnancies complicated by pregestational diabetes mellitus is not well studied, as the Antenatal Late Preterm Steroids trial excluded twin pregnancies and pregnancies complicated by pregestational diabetes mellitus. This study aimed to examine the change in the incidence rate of immediate assisted ventilation use and ventilation use for more than 6 hours among 2 populations after the dissemination of the Antenatal Late Preterm Steroids trial at the population level. This study was a retrospective analysis of publicly available US birth certificate data. The study period was from August 1, 2014, to April 30, 2018. The dissemination period of the Antenatal Late Preterm Steroids trial was from February 2016 to October 2016. Population-based interrupted time series analyses were performed for 2 target populations: (1) twin pregnancies not complicated by pregestational diabetes mellitus and (2) singleton pregnancies complicated by pregestational diabetes mellitus. For both target populations, analyses were limited to individuals who delivered nonanomalous live neonates between 34 0/7 and 36 6/7 weeks of gestation (vaginal or cesarean delivery). As a sensitivity analysis, a total of 23 placebo tests were conducted before (5 tests) and after (18 tests) the dissemination period. For the analysis of late preterm twin deliveries, 191,374 individuals without pregestational diabetes mellitus were identified. For the analysis of late preterm singleton pregnancy with pregestational diabetes mellitus, 21,395 individuals were identified. After the dissemination period, the incidence rate of immediate assisted ventilation use for late preterm twin deliveries was significantly lower than the expected value based on the pre-Antenatal Late Preterm Steroids trial trend (11.6% observed vs 13.0% expected; adjusted incidence rate ratio, 0.87; 95% confidence interval, 0.78-0.97). The incidence rate of ventilation use for more than 6 hours among late preterm twin deliveries did not change significantly after the dissemination of the Antenatal Late Preterm Steroids trial. A significant increase in the incidence rate of immediate assisted ventilation use and ventilation use for more than 6 hours was found among singleton pregnancies with pregestational diabetes mellitus. However, the results of placebo tests suggested that the increase in incidence was not necessarily due to the dissemination period of the Antenatal Late Preterm Steroids trial. The dissemination of the Antenatal Late Preterm Steroids trial was associated with decreased incidence of immediate assisted ventilation use, but no change in ventilation use for more than 6 hours, among late preterm twin deliveries in the United States. In contrast, the incidence of neonatal respiratory outcomes among singleton deliveries with pregestational diabetes mellitus did not decrease after the dissemination of the Antenatal Late Preterm Steroids trial.