ALPS Trial Dissemination: Effects on Pregnant People with Diabetes and their Infants

Abstract

To examine the effects of the Antenatal Late Preterm Steroids (ALPS) trial on late preterm steroid use and neonatal assisted ventilation rates among people with diabetes. Interrupted time series analysis of singleton, liveborn, non-anomalous infants born between 34-36 weeks to women with pre-existing or gestational diabetes using US birth certificate data. The period from Feb 2016 (ALPS trial publication) to Oct 2016 (updated ACOG Committee Opinion publication) was considered the dissemination period. We examined the change in late preterm steroid use and rates of 1) any assisted ventilation and 2) assisted ventilation for >6 hours. Monthly rates before and after the dissemination period were compared between Jan 2014 and Dec 2019, controlling for seasonal variation in the outcomes and monthly distribution of deliveries by week of gestation. 143,707 women with diabetes gave birth during the analysis period; 20.2% of this cohort had pre-gestational diabetes. Figure 1 shows the unadjusted monthly rates of steroid administration and assisted ventilation use in this population and the adjusted linear pre- and post-dissemination period trend. After the ALPS trial publication and the dissemination period, there was an immediate 8.77-percentage point (pp) increase in late preterm steroid use (95% CI 7.76, 9.79). There was no significant change in the rate of assisted ventilation (0.42-pp decrease; 95% CI -1.29, 0.46) or assisted ventilation for more than 6 hours (0.36-pp increase; 95% CI -0.21, 0.94). Similar findings were seen in the subgroup of women with pre-gestational diabetes. The rate of late preterm steroid administration among this population increased substantially after the trial’s dissemination without observable improvement in neonatal assisted ventilation rates. Given the underlying risk of hypoglycemia in the infants of people with diabetes, further research is needed to assess the benefits and potential risks of late preterm steroid administration in this population.