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Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)

NCT02309138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 921

Last updated 2020-07-20

Study results available
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Summary

This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes. Maternal metabolic profiles and infant growth will be assessed at randomization and at one year postpartum.

Conditions

  • Gestational Diabetes
  • Pregnancy
  • Glucose Intolerance

Interventions

DIAGNOSTIC_TEST

Gestational diabetes screening with fasting 3 hour 100 gm

Participants receive fasting 3 hour 100 gm oral glucose tolerance test

DIAGNOSTIC_TEST

Gestational diabetes screening with fasting 2 hour 75g

Participants receive fasting 2 hour 75 gm oral glucose tolerance test

Sponsors & Collaborators

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

    collaborator NIH

  • Esa M Davis, MD MPH FAAFP

    lead OTHER

Principal Investigators

  • Esa M Davis, MD MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-11
Primary Completion
2019-07-03
Completion
2020-06-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02309138 on ClinicalTrials.gov