Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study (E-ALPS)
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|ClinicalTrials.gov Identifier: NCT03076775|
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : July 17, 2019
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?
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Preterm Neonatal Hypoglycemia Hyperglycemia Drug Induced||Other: Maternal glycemic control||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fetal Metabolic Consequences of Late Preterm Steroid Exposure|
|Actual Study Start Date :||June 8, 2017|
|Estimated Primary Completion Date :||May 30, 2020|
|Estimated Study Completion Date :||May 30, 2020|
Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.
Other: Maternal glycemic control
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.
No Intervention: Usual Care
Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
- Umbilical cord blood C-peptide [ Time Frame: Delivery ]C-peptide level (mcg/L) as measure of fetal hyperinsulinemia
- Neonatal hypoglycemia [ Time Frame: 48 hours of life ]Neonatal capillary blood glucose < 40 mg/dL
- Neonatal intensive care unit admission [ Time Frame: Date of delivery to date of discharge from hospital, assessed up to 28 days ]Admission to the neonatal intensive care unit for > 24 hours
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076775
|Contact: Ashley N Battarbee, MDfirstname.lastname@example.org|
|Contact: Kim Boggess, MDemail@example.com|
|United States, North Carolina|
|University of North Carolina - Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Ashley N Battarbee, MD|
|Principal Investigator:||Ashley N Battarbee, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Kim Boggess, MD||University of North Carolina, Chapel Hill|