Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study
Condition: Pregnancy Preterm; Neonatal Hypoglycemia; Hyperglycemia Drug Induced
MeSH terms: Premature Birth; Hypoglycemia; Hyperglycemia
Study type: Interventional

Summary: 
      Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36
      weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal
      treatment with betamethasone in the late preterm period significantly reduces neonatal
      respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.

      This research study will attempt to answer the following primary question: Does a management
      protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia,
      compared to usual antepartum care?
    

Detailed description: 
      Euglycemia after Antenatal Late Preterm Steroids, the E-ALPS Study:

      There is a fundamental gap in understanding the adverse metabolic effects of antenatal late
      preterm steroids (ALPS). In 2016, an important randomized clinical trial of 2827 late preterm
      pregnancies showed that antenatal betamethasone (BMZ) significantly reduced neonatal
      respiratory complications compared with placebo. However, those neonates exposed to BMZ were
      also more likely to have hypoglycemia at birth. This unexpected adverse outcome raised
      concern among both obstetricians and neonatologists and remains an important knowledge gap to
      be filled. The rationale for the proposed research is that steroid-induced maternal
      hyperglycemia leads to transient fetal hyperinsulinemia, which causes hypoglycemia in
      neonates that are delivered during this time-period. Thus, the fetal metabolic consequences
      and subsequent neonatal hypoglycemia observed after exposure to BMZ in utero can be prevented
      by achieving maternal euglycemia prior to delivery.

      This protocol describes a randomized clinical trial to evaluate whether screening for and
      treatment of steroid-induced hyperglycemia in non-diabetic women treated with BMZ in the late
      preterm period can decrease the rate of fetal hyperinsulinemia, thus reducing neonatal
      hypoglycemia and improving short-term neonatal outcomes.

      This study was formerly approved as Institutional Review Board #16-3200.
    

Intervention name(s): Maternal glycemic control
Intervention type(s): Other
Intervention description(s): Maternal capillary blood glucose testing will be performed according to oral intake status: every 2 hours if not eating (NPO) or fasting and 1-hour postprandial if eating regular meals. Hyperglycemia, defined based on the American Diabetes Association and the American College of Obstetricians and Gynecologists recommendations as well as current practice at study sites, will be treated according to study guidelines based on oral intake status: insulin infusion if NPO and subcutaneous insulin if eating regular meals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Betamethasone; Late preterm; Steroids