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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
86
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Umbilical Cord Blood C-peptide
C-peptide level (ng/mL) as measure of fetal hyperinsulinemia
Time frame: At delivery
Umbilical Cord Blood Cortisol
Cortisol level (ug/mL) as measure of fetal immune suppression
Time frame: At delivery
Umbilical Insulin-Like Growth Factor 1
Insulin-like growth factor 1 level (ng/mL) as a measure of in utero metabolic status
Time frame: At delivery
Umbilical Cord Blood Leptin
Leptin level (ng/mL) as measure of fetal adiposity
Time frame: At delivery
Neonatal Hypoglycemia
Number of neonates with capillary blood glucose \< 40 mg/dL
Time frame: After birth, up to 48 hours of life
Neonatal Hypoglycemia Treatment
Number of neonates with hypoglycemia requiring treatment with dextrose gel or dextrose intravenous fluids
Time frame: After birth, during hospital admission, assessed up to 28 days
Neonatal Glucose Nadir
Lowest neonatal capillary blood glucose (mg/dL)
Time frame: After birth, during hospital admission, assessed up to 28 days
Timing of Neonatal Blood Glucose Nadir
Number of hours after birth when lowest neonatal capillary blood glucose was measured
Time frame: After birth, during hospital admission, assessed up to 28 days
Neonatal Intensive Care Unit Admission
Number of neonates admitted to the neonatal intensive care unit for \> 24 hours
Time frame: Date of delivery to date of discharge from hospital, assessed up to 28 days
Neonatal Intensive Care Unit Length of Stay
Number of days of neonatal intensive care unit stay
Time frame: From neonatal intensive care unit admission to discharge, assessed up to 28 days
Neonatal Seizures
Number of neonates who had seizures
Time frame: After birth, during hospital admission, assessed up to 28 days
Neonatal Mortality
Number of neonates who died
Time frame: After birth, during hospital admission, assessed up to 28 days
Maternal Hyperglycemia
Number of mothers with intrapartum capillary blood glucose \>110 mg/dL, fasting capillary blood glucose \>95 mg/dL, or 1-hour postprandial capillary blood glucose \>140 mg/dL
Time frame: For five days after first dose of betamethasone administration
Maternal Insulin Treatment
Number of mothers who received insulin for treatment of hyperglycemia
Time frame: For five days after first dose of betamethasone administration
Maternal Hypoglycemia
Number of mothers with capillary blood glucose \<60 mg/dL
Time frame: For five days after first dose of betamethasone administration
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