Early Gestational Diabetes Screening in the Gravid Obese Woman (EGGO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University of Alabama at Birmingham
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ochsner Health System
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01864564
First received: May 22, 2013
Last updated: August 7, 2016
Last verified: August 2016
  Purpose

Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese women (body mass index ≥30.0) will result in improved perinatal outcomes.

Specific Aim 2: To test the hypothesis that a lower diagnostic threshold for GDM at 14-18 weeks will result in improved detection of GDM and reduce the need for third-trimester testing.

Specific Aim 3: To test the hypothesis that 1,5-anhydroglucitol, a sensitive marker of hyperglycemia, can be used as a simple and sensitive serum test for GDM in the obese population.


Condition Intervention
Gestational Diabetes
Obesity
Other: Early Screen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Early Gestational Diabetes Screening in the Gravid Obese Woman

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Composite Perinatal Outcome [ Time Frame: Within 6 weeks of delivery ] [ Designated as safety issue: No ]
    Any one of the following: Macrosomia (birth weight > 4000 g), primary cesarean, gestational hypertension, preeclampsia, shoulder dystocia, neonatal hyperbilirubinemia, neonatal hypoglycemia (<40 mg/dL)


Secondary Outcome Measures:
  • Macrosomia [ Time Frame: Within 6 weeks of delivery ] [ Designated as safety issue: No ]
    Birth weight >4000 g

  • Primary cesarean delivery [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    Primary cesarean : delivery via cesarean, first cesarean (does not include repeat cesarean deliveries)

  • Pregnancy induced hypertension [ Time Frame: Within 6 weeks of delivery ] [ Designated as safety issue: No ]
    Includes gestational hypertension and preeclampsia

  • Shoulder dystocia [ Time Frame: At birth ] [ Designated as safety issue: No ]
    Shoulder dystocia as identified by delivering physician

  • Neonatal hyperbilirubinemia [ Time Frame: Within 6 weeks of delivery ] [ Designated as safety issue: No ]
  • Neonatal hypoglycemia [ Time Frame: Within 6 weeks of delivery ] [ Designated as safety issue: No ]
    Blood sugar level <40 mg/dL

  • Preterm delivery [ Time Frame: Diagnosed at the time of delivery ] [ Designated as safety issue: No ]
    Delivery <37 weeks gestation


Estimated Enrollment: 1160
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Routine Screening

Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care.

All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.

Experimental: Early Screening

Obese women will be randomized to be screened at 14-18 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-18 weeks will be re-screened at 24-28 weeks per the standard of care.

All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.

Other: Early Screen
Women will be randomized to be screened for gestational diabetes at 14-18 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • 18 years and older
  • Body mass index >=30.0
  • <18 weeks gestation at presentation for care

Exclusion Criteria:

  • Prior cesarean
  • History of bariatric surgery
  • Major maternal medical illness (cardiac disease, HIV, hemoglobinopathy, oxygen requirement)
  • Chronic prednisone use
  • Known fetal anomalies
  • Multifetal gestation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864564

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Lorie M Harper, MD, MSCI    205-975-0515    lmharper@uabmc.edu   
Principal Investigator: Lorie M Harper, MD, MSCI         
United States, Louisiana
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Sherri Longo, MD    504-842-4155    slongo@ochsner.org   
Sponsors and Collaborators
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ochsner Health System
Investigators
Principal Investigator: Lorie M Harper, MD, MSCI University of Alabama at Birmingham
  More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01864564     History of Changes
Other Study ID Numbers: F121008004  K12HD001258 
Study First Received: May 22, 2013
Last Updated: August 7, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Alabama at Birmingham:
Gestational diabetes
Screening
Obesity
Anhydroglucitol

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on August 23, 2016