Utility Of Hemoglobin A1C For The Diagnosis Of Gestational Diabetes

NCT02273193 | Completed

• 1 other identifier: FWH20130041H
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Fasting Glucose will be obtained during the first trimester of pregnancy

  13 weeks

Secondary Outcomes (1)

• Hemoglobin A1c will be obtained during the second trimester of pregnancy (between 24-28 weeks)

  24-28 weeks

Study Arms (1)

Pregnant Women

Pregnant Women in the first trimester (\<13 weeks) of pregnancy and the second trimester of pregnancy.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test

You may qualify if:

• Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin).

You may not qualify if:

• Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin) known to have and/or develop during the study any of the following upon review of their medical record:
• Hemoglobinopathy (including sickle cell disease or trait, thalassemia)
• Chronic kidney disease
• Diabetes
• Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test (beta human chorionic gonadotropin) taking any of the following:
• Erythropoietin
• Daily oral steroids

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Officials

• Paul Crawford, MD

  Mike O'Callaghan Federal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 23, 2014
• Study Start: October 14, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)