Euglycemia After Antenatal Late Preterm Steroids, the E-ALPS Study (E-ALPS)

January 21, 2022 updated by: University of North Carolina, Chapel Hill

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical Cord Blood C-peptide
Time Frame: At delivery
C-peptide level (ng/mL) as measure of fetal hyperinsulinemia
At delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical Cord Blood Cortisol
Time Frame: At delivery
Cortisol level (ug/mL) as measure of fetal immune suppression
At delivery
Umbilical Insulin-Like Growth Factor 1
Time Frame: At delivery
Insulin-like growth factor 1 level (ng/mL) as a measure of in utero metabolic status
At delivery
Umbilical Cord Blood Leptin
Time Frame: At delivery
Leptin level (ng/mL) as measure of fetal adiposity
At delivery
Neonatal Hypoglycemia
Time Frame: After birth, up to 48 hours of life
Number of neonates with capillary blood glucose < 40 mg/dL
After birth, up to 48 hours of life
Neonatal Hypoglycemia Treatment
Time Frame: After birth, during hospital admission, assessed up to 28 days
Number of neonates with hypoglycemia requiring treatment with dextrose gel or dextrose intravenous fluids
After birth, during hospital admission, assessed up to 28 days
Neonatal Glucose Nadir
Time Frame: After birth, during hospital admission, assessed up to 28 days
Lowest neonatal capillary blood glucose (mg/dL)
After birth, during hospital admission, assessed up to 28 days
Timing of Neonatal Blood Glucose Nadir
Time Frame: After birth, during hospital admission, assessed up to 28 days
Number of hours after birth when lowest neonatal capillary blood glucose was measured
After birth, during hospital admission, assessed up to 28 days
Neonatal Intensive Care Unit Admission
Time Frame: Date of delivery to date of discharge from hospital, assessed up to 28 days
Number of neonates admitted to the neonatal intensive care unit for > 24 hours
Date of delivery to date of discharge from hospital, assessed up to 28 days
Neonatal Intensive Care Unit Length of Stay
Time Frame: From neonatal intensive care unit admission to discharge, assessed up to 28 days
Number of days of neonatal intensive care unit stay
From neonatal intensive care unit admission to discharge, assessed up to 28 days
Neonatal Seizures
Time Frame: After birth, during hospital admission, assessed up to 28 days
Number of neonates who had seizures
After birth, during hospital admission, assessed up to 28 days
Neonatal Mortality
Time Frame: After birth, during hospital admission, assessed up to 28 days
Number of neonates who died
After birth, during hospital admission, assessed up to 28 days
Maternal Hyperglycemia
Time Frame: For five days after first dose of betamethasone administration
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
For five days after first dose of betamethasone administration
Maternal Insulin Treatment
Time Frame: For five days after first dose of betamethasone administration
Number of mothers who received insulin for treatment of hyperglycemia
For five days after first dose of betamethasone administration
Maternal Hypoglycemia
Time Frame: For five days after first dose of betamethasone administration
Number of mothers with capillary blood glucose <60 mg/dL
For five days after first dose of betamethasone administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Ashley N Battarbee, MD, MSCR, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Actual)

February 18, 2021

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1970
  • 1R03HD096188-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected as a part of this trial will only be available to the study team. Protected health information will only be available to the recruiting site in order to complete data abstraction.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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