CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 962 enrolled
Drug / intervention
Early Screenother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01864564
NCT01864564N/ACompleted
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Early Gestational Diabetes Screening in the Gravid Obese Woman

University of Alabama at Birmingham·interventional·Posted May 29, 2013·Updated Jun 23, 2020

In Brief

A clinical study evaluating Early Screen for Gestational Diabetes and Obesity. Completed, enrolled 962 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGestational Diabetes, Obesity
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ochsner Health System

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 29, 2013
Enrollment StartJun 18, 2013
Primary CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 13.1 years ago

Interventions

Early Screenother

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.