Early Gestational Diabetes Screening in the Gravid Obese Woman

NCT01864564 | Completed Results

• 2 other identifiers: F121008004K12HD001258
• Study Type: interventional
• Target: 962
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gestational Diabetes; Obesity

Keywords

Gestational diabetes; Screening; Obesity; Anhydroglucitol

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Composite Perinatal Outcome

  Any one of the following: Macrosomia (birth weight \> 4000 g), primary cesarean, gestational hypertension, preeclampsia, shoulder dystocia, neonatal hyperbilirubinemia, neonatal hypoglycemia (\<40 mg/dL)

  Baseline to within 6 weeks of delivery

Secondary Outcomes (10)

• Number of Participants With Macrosomia

  Within 6 weeks of delivery

• Primary Cesarean Delivery

  Delivery

• Pregnancy Induced Hypertension

  Within 6 weeks of delivery

• Shoulder Dystocia

  At birth

• Neonatal Hyperbilirubinemia

  Within 6 weeks of delivery

Study Arms (2)

Routine Screening

NO INTERVENTION

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.

Early Screening

EXPERIMENTAL

Obese women will be randomized to be screened at 14-19.9 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 14-19.9 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

Interventions

Early Screen OTHER

Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.

Early Screening

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant
• years and older
• Body mass index \>=30.0
• \<20 weeks gestation at presentation for care

You may not qualify if:

• Prior cesarean
• History of bariatric surgery
• Major maternal medical illness (cardiac disease, HIV, hemoglobinopathy, oxygen requirement)
• Chronic prednisone use
• Known fetal anomalies
• Multifetal gestation

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Ochsner Health System: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Related Publications (1)

• Harper LM, Jauk V, Longo S, Biggio JR, Szychowski JM, Tita AT. Early gestational diabetes screening in obese women: a randomized controlled trial. Am J Obstet Gynecol. 2020 May;222(5):495.e1-495.e8. doi: 10.1016/j.ajog.2019.12.021. Epub 2020 Jan 9.

  PMID: 31926951 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Lack of blinding of participants and providers may have introduced bias. The study population being largely Black or Hispanic women and without private insurance limits the generalizability.

Results Point of Contact

• Title: Lorie M. Harper, MD, MSCI
• Organization: University of Texas at Austin

lorie.harper@austin.utexas.edu

512-324-7036

Study Officials

• Lorie M Harper, MD, MSCI

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 29, 2013
• Study Start: June 18, 2013
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: June 23, 2020
• Results First Posted: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)