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Utility Of Hemoglobin A1C For The Diagnosis Of Gestational Diabetes

NCT02273193 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 643

Last updated 2018-11-28

No results posted yet for this study

Summary

A prospective cohort research study is being conducted in the Mike O'Callaghan Federal Medical Center (MOFMC), Department of Family Medicine, Obstetrics Clinic to determine if early screening with hemoglobin A1C, a blood test for blood glucose, can be used to identify women with hyperglycemia or Gestational Diabetes Mellitus (GDM) in the first semester of pregnancy in place of a fasting blood glucose blood test. This study will also determine how hemoglobin A1C compares with the oral glucose tolerance test (GTT) done as a standard of care with the standard of care second trimester prenatal care testing. Subjects recruited and consented during the Obstetrics Orientation Class will have two (2) additional blood tests drawn with their standard of care prenatal tests in the first trimester (\<13 weeks) of pregnancy and at the second trimester (24-28 weeks) of pregnancy. Subjects identified as having GDM by blood HbA1C, fasting glucose or the 2 hr OGTT will be treated for GDM with standard of care by their primary care provider. The correlation of blood HbA1C with the fasting glucose in the first trimester of pregnancy and with the 2 hr OGTT will be determined for early detection and diagnosis of GDM. This study will contribute to understanding the role of HbA1C in pregnancy and the development of GDM.

Conditions

  • Gestational Diabetes Mellitus

Sponsors & Collaborators

  • Mike O'Callaghan Military Hospital

    lead FED

Principal Investigators

  • Paul Crawford, MD · Mike O'Callaghan Federal Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-14
Primary Completion
2017-07-01
Completion
2017-07-01

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 NCT02273193 on ClinicalTrials.gov