Gestational Diabetes Diagnostic Methods
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Dietary modification and medications
Intervention type(s): Behavioral
Intervention description(s): Patients diagnosed with gestational diabetes will receive dietary advice and instruction on blood glucose monitoring from their regular prenatal doctors, consistent with standard of care practices. Medications (glyburide, insulin) will be used as needed to assist with blood glucose control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Gestational Diabetes