N/A
N=86
Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study
Pregnancy Preterm · Neonatal Hypoglycemia · Hyperglycemia Drug Induced
Bottom Line
View on ClinicalTrials.gov: NCT03076775 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Umbilical Cord Blood C-peptide — 1.02; 1.09 ng/mL — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Maternal glycemic control (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Umbilical Cord Blood C-peptide |
1.02; 1.09 | 0.97 |
| SECONDARY Umbilical Cord Blood Cortisol |
2.0; 2.5 | 0.24 |
| SECONDARY Umbilical Insulin-Like Growth Factor 1 |
78; 58 | 0.15 |
| SECONDARY Umbilical Cord Blood Leptin |
7.5; 5.6 | 0.55 |
| SECONDARY Neonatal Hypoglycemia |
20; 21 | 0.83 |
| SECONDARY Neonatal Hypoglycemia Treatment |
9; 8 | 0.79 |
| SECONDARY Neonatal Glucose Nadir |
42.3; 42.2 | 0.97 |
| SECONDARY Timing of Neonatal Blood Glucose Nadir |
1.7; 1.7 | 0.44 |
| SECONDARY Neonatal Intensive Care Unit Admission |
15; 21 | 0.16 |
| SECONDARY Neonatal Intensive Care Unit Length of Stay |
6; 7 | 0.59 |
| SECONDARY Neonatal Seizures |
0; 0 | — |
| SECONDARY Neonatal Mortality |
0; 0 | — |
| SECONDARY Maternal Hyperglycemia |
32; 0 | — |
| SECONDARY Maternal Insulin Treatment |
22 | — |
| SECONDARY Maternal Hypoglycemia |
— | — |
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?
Eligibility Criteria
Inclusion Criteria
- Singleton gestation with no known major fetal anomalies
- Gestational age at randomization between 34 weeks 0 days and 36 weeks 5 days
- Receiving antenatal betamethasone due to high probability of delivery in late preterm period
Exclusion Criteria
- Pre-gestational or gestational diabetes mellitus
- Maternal contraindication to insulin
- Planned outpatient treatment with antenatal betamethasone
- Participation in clinical trial that could affect primary outcome or participation in this trial in a previous pregnancy
Data sourced from ClinicalTrials.gov (NCT03076775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.