Late-preterm steroid use among individuals with pregestational diabetes mellitus and with twin gestations

Abstract

Administering betamethasone to individuals who may deliver between 34 and 36 weeks of gestation decreased the risk of neonatal respiratory complications in the Antenatal Late Preterm Steroids (ALPS) trial.1Gyamfi-Bannerman C. Thom E.A. Blackwell S.C. et al.Antenatal betamethasone for women at risk for late preterm delivery.N Engl J Med. 2016; 374: 1311-1320Crossref PubMed Google Scholar The trial excluded patients with pregestational diabetes mellitus and twin pregnancies; guidelines from professional societies emphasized caution before recommending late-preterm steroids in these populations.2Society for Maternal-Fetal Medicine (SMFM) Publications CommitteeImplementation of the use of antenatal corticosteroids in the late preterm birth period in women at risk for preterm delivery.Am J Obstet Gynecol. 2016; 215: B13-B15Abstract Full Text Full Text PDF PubMed Scopus (66) Google Scholar,3American College of Obstetricians and Gynecologists’ Committee on Obstetric PracticeSociety for Maternal–Fetal Medicine. Committee Opinion No. 677: antenatal corticosteroid therapy for fetal maturation.Obstet Gynecol. 2016; 128: e187-e194Crossref PubMed Scopus (0) Google Scholar Our objective was to understand if the dissemination of the ALPS trial affected steroid use in these groups. We conducted an interrupted time-series (ITS) analysis using US natality data from 2014 to 2018. The primary exposure was the ALPS trial dissemination (February–October 2016), and the outcome was antenatal steroid use. Quarterly steroid administration rates were calculated in the 2 years before and after the dissemination period. The ITS model used Poisson regressions to examine the associations between ALPS trial dissemination and steroid exposure in 2 cohorts: patients delivering at 34 to 36 weeks’ gestation with (1) twins, or (2) pregestational diabetes mellitus and a singleton. A more detailed description of methods is included in the online Supplement. Analyses were performed using Stata, version 15.1 (StataCorp, College Station, TX). P values <.05 were considered statistically significant. The Mass General Brigham Institutional Review Board determined this study exempt from review as non–human subjects research. During the study, 41,181 and 42,162 patients with twin pregnancies and 9,713 and 11,877 patients with pregestational diabetes mellitus delivered between 34 and 36 weeks of gestation in the pre- and post-ALPS trial dissemination periods, respectively. Among twin pregnancies, the observed rate of steroid administration was 19.9% vs 11.5% (expected rate based on preperiod trends) in the first quarter after the dissemination period (unadjusted incidence rate ratio (IRR), 1.76; 95% confidence interval [CI], 1.58–1.96; adjusted IRR (aIRR), 1.73; 95% CI, 1.58–1.89) (Figure). Similarly, the steroid administration rate was 17.0% (observed) vs 8.0% (expected) in patients with pregestational diabetes mellitus (IRR, 2.11; 95% CI, 1.64–2.70; aIRR, 2.13; 95% CI, 1.57–2.90). Full model output is included in the online Supplement (Supplemental Tables 1 and 2). The dissemination of the ALPS trial was associated with increased steroid administration among 2 populations outside the original inclusion criteria. The Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists recently emphasized shared decision-making regarding this intervention in twin pregnancies but continued to recommend against its use in people with pregestational diabetes mellitus given the unknown benefits and potential risks, such as neonatal hypoglycemia, which was noted more often in the steroid-exposed group in the ALPS trial.1Gyamfi-Bannerman C. Thom E.A. Blackwell S.C. et al.Antenatal betamethasone for women at risk for late preterm delivery.N Engl J Med. 2016; 374: 1311-1320Crossref PubMed Google Scholar,4Society for Maternal-Fetal Medicine (SMFM)Electronic address: [email protected], Reddy UM, Deshmukh U, Dude A, Harper L, Osmundson SS. Society for Maternal-Fetal Medicine Consult Series #58: use of antenatal corticosteroids for individuals at risk for late preterm delivery: replaces SMFM Statement #4, implementation of the use of antenatal corticosteroids in the late preterm birth period in women at risk for preterm delivery.Am J Obstet Gynecol. 2021; 225 (August 2016): B36-B42Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar Additional studies are indicated to clarify the benefits and risks in these populations and to examine the factors and clinical decision-making contributing to their increased use.