Utility Of Hemoglobin A1C For The Diagnosis Of Gestational Diabetes

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

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