At a glance
ClinicalIndex Comparison Record- ✓Singleton gestation with no known major fetal anomalies
- ✓Gestational age 34 weeks 0 days to 36 weeks 5 days at randomization
- ✓High probability of delivery in late preterm period necessitating antenatal betamethasone
- ✕Pre-gestational or gestational diabetes mellitus
- ✕Maternal contraindication to insulin
- ✕Planned outpatient treatment with antenatal betamethasone
- ✕Participation in another clinical trial affecting primary outcome or prior participation in this trial
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fetal Metabolic Consequences of Late Preterm Steroid Exposure
In Brief
A clinical study evaluating Maternal glycemic control for Pregnancy Preterm and 2 related conditions. Completed, enrolled 86 participants across 2 sites.
Detailed 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?
Study Details
Timeline
Interventions
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.