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Utility Of Hemoglobin A1C For The Diagnosis Of Gestational Diabetes (A1cGDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273193
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

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.

Condition or disease
Gestational Diabetes Mellitus

Detailed Description:

This is a prospective cohort research study conducted in the Mike O'Callaghan Federal Medical Center (MOFMC), Department of Family Medicine Residency and Obstetrics Clinics. Subjects will be pregnant female active duty or DoD beneficiaries 18 years or older recruited from the MOFMC, Department of Family Medicine Residency Clinic, and Obstetrics Orientation Class at Nellis AFB. At the screening, the Research Assistant discusses the study, answers all questions, obtains Informed Consent, and schedules appointments for routine OB care. The research design includes a screening visit to obtain written consent and two (2) additional laboratory blood tests obtained during the standard of care prenatal screen testing during the first and second trimesters of pregnancy. Each laboratory blood test will be done via 1 venipuncture for 5-10 ml (1-2 teaspoons) of blood. The OB nurse orders all labs upon completion of the Obstetrics Orientation Class.

Screening Visit: Initial Standard of Care Obstetrics Appointment

  • Obtain subject signed Informed Consent document and HIPAA Authorization
  • Demographic data: age, race, weight, height, estimated week of gestation
  • Review past medical history

First Trimester Prenatal Visit (<13 weeks) Screen Testing

  • Subjects will have routine prenatal labs drawn to include the HbA1C blood test which is standard of care
  • Subjects will have fasting (10 hour) glucose blood test will be ordered along with these labs (research driven)

Second Trimester Prenatal Visit (24-28 weeks)

  • Subjects will have routine prenatal labs drawn to include the 2 hr glucose tolerance test (2 hr OGTT) which is standard of care
  • Subjects will have will be the HbA1C blood test ordered along with these labs (research driven)

Delivery and Neonatal Data Collection

-Select data regarding delivery and neonatal health will be tracked. All of this data is already routinely collected as standard of care and will be found in the patient record. This will require no interaction with the patient or the neonate

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Study Type : Observational
Actual Enrollment : 643 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Utility Of Hemoglobin A1C (HbA1C) For The Diagnosis Of Gestational Diabetes Mellitus (GDM).
Actual Study Start Date : October 14, 2014
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: A1C

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



Primary Outcome Measures :
  1. Fasting Glucose will be obtained during the first trimester of pregnancy [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Hemoglobin A1c will be obtained during the second trimester of pregnancy (between 24-28 weeks) [ Time Frame: 24-28 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Active duty or DoD beneficiaries of childbearing age 18 years or older with a positive pregnancy test
Criteria

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

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

Exclusion:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273193


Locations
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United States, Nevada
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
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Principal Investigator: Paul Crawford, MD Mike O'Callaghan Federal Medical Center

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Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02273193    
Other Study ID Numbers: FWH20130041H
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications