Gestational Diabetes Diagnostic Methods
Gestational Diabetes Diagnostic Methods
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).
This is a pilot feasibility study of 40 pregnant women between 24-28 weeks gestation 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.

 Forty women 18 years of age or older will be recruited at 20-24 weeks pregnancy from the
 ob/gyn outpatient practices at Magee-Women's hospital (MWH). Eligible women will return to
 MWH main lab between 24-28 weeks gestation for the routine 1 hour 50gm glucose challenge
 test. Women with blood glucose values less than 200 will be randomized to receive either the
 fasting 2 hour 75 gm oral glucose tolerance test (OGTT)or the 3 hour 100 gm OGGT within two
 weeks. Gestational diabetes will be determined for the 2 hour 75 gm OGGT arm based on the
 2011 ADA guidelines and the 3 hour 100 gm OGGT arm based on the Carpenter and Coustan
 criteria. Patients and their providers will be informed of the diagnosis of gestational
 diabetes, but they will be blinded to the criteria used to make the diagnosis as well as the
 specific results of glucose tolerance testing.

 Chart reviews will be conducted to assess for perinatal maternal and infant health factors
 (e.g.pregnancy weight, gestational weight gain, co morbidities) as well as for data on
 perinatal outcomes related to GDM such as macrosomia, c-sections, and birth trauma. Two brief
 self-administered questionnaire will assess participants' views on screening for gestational
 diabetes and assess participants experience with and solicit feedback on the study
 procedures.

 At the end of this pilot study, the investigators will have experience with recruitment,
 retention, and randomization procedures and have made the necessary protocol revisions. If
 successful, this feasibility study will provide the preliminary data and feasibility
 justification needed to conduct a larger randomized control trial to compare the
 effectiveness of two diagnostic methods for gestational diabetes.
Inclusion Criteria:

 -  Singleton pregnancy

 -  Plan to undergo gestational diabetes screening at 24-28 weeks' gestation.

 Exclusion Criteria:

 -  Existing Type 1 or Type 2 diabetes

 -  Diabetes diagnosed early in pregnancy (less than 24 weeks gestation)

 -  Multiple gestation (e.g. twins, triplets)

 -  Chronic hypertension (requiring medications)

 -  Oral, IM or IV corticosteroid use within the previous 30 days

 -  Major congenital anomaly or anticipated preterm delivery before 28 weeks

 -  Inability to complete 50 gram GCT before 28 completed weeks' gestation

 -  Patients with known HIV, Hepatitis B or C virus.