Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/9/2018 |
| Start Date: | June 8, 2017 |
| End Date: | May 30, 2020 |
| Contact: | Ashley N Battarbee, MD |
| Email: | ashley_battarbee@med.unc.edu |
| Phone: | 9199661601 |
Fetal Metabolic Consequences of Late Preterm Steroid Exposure
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?
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.
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.
Inclusion Criteria:
1. Singleton gestation with no known major fetal anomalies
2. Gestational age at randomization between 34 weeks 0 days and 36 weeks 5 days
3. Receiving antenatal betamethasone due to high probability of delivery in late preterm
period
Exclusion Criteria:
1. Pre-gestational or gestational diabetes mellitus
2. Maternal contraindication to insulin
3. Planned outpatient treatment with antenatal betamethasone
4. Participation in clinical trial that could affect primary outcome or participation in
this trial in a previous pregnancy
We found this trial at
1
site
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
