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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03076775
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : October 1, 2019
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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?

Condition or disease Intervention/treatment Phase
Pregnancy Preterm Neonatal Hypoglycemia Hyperglycemia Drug Induced Other: Maternal glycemic control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

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.

Primary Outcome Measures :
  1. Umbilical cord blood C-peptide [ Time Frame: Delivery ]
    C-peptide level (mcg/L) as measure of fetal hyperinsulinemia

Secondary Outcome Measures :
  1. Neonatal hypoglycemia [ Time Frame: 48 hours of life ]
    Neonatal capillary blood glucose < 40 mg/dL

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Recruiting pregnant females
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03076775

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Contact: Ashley N Battarbee, MD, MSCR 2059752361
Contact: Kim Boggess, MD

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ashley N Battarbee, MD, MSCR         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kim A Boggess, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Ashley N Battarbee, MD, MSCR University of Alabama at Birmingham
Principal Investigator: Kim Boggess, MD University of North Carolina, Chapel Hill

American Diabetes Association. Standards of medical care in diabetes - 2016. Diabetes Care. 2016; 39(suppl1):S1-S106.

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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT03076775    
Other Study ID Numbers: 18-1970
1R03HD096188-01 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Late preterm
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Glucose Metabolism Disorders
Metabolic Diseases