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Gestational Diabetes Diagnostic Methods

NCT01540396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-02-04

No results posted yet for this study

Summary

This is a pilot feasibility study of 40 pregnant women to test the investigators' recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes. The two methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1 hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and Coustan criteria).

Conditions

  • Gestational Diabetes

Interventions

BEHAVIORAL

Dietary modification and medications

Patients diagnosed with gestational diabetes will receive dietary advice and instruction on blood glucose monitoring from their regular prenatal doctors, consistent with standard of care practices. Medications (glyburide, insulin) will be used as needed to assist with blood glucose control.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Christina M Scifres, MD · University of Pittsburgh

  • Esa Davis, MD MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-02-28
Completion
2014-12-31

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 NCT01540396 on ClinicalTrials.gov