Gestational Diabetes Mellitus Trial (GDM)
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Gestational diabetes mellitus (GDM) is a type of diabetes (high blood sugar) that occurs in
      pregnant women. This study will determine whether treating pregnant women who have mild GDM
      improves the health of their babies. The follow-up study will examine whether factors during
      the previous pregnancy (such as blood sugar during pregnancy) are associated with the woman
      and her child's health 4-9 years later.
    

Detailed description: 
      Gestational diabetes mellitus is defined as glucose intolerance of variable severity with
      onset or first recognition during pregnancy. The definition applies regardless of insulin use
      for treatment or the persistence of the condition after pregnancy, and does not exclude the
      possibility that unrecognized glucose intolerance or overt diabetes may have preceded the
      pregnancy. Pre-existing diabetes substantially contributes to perinatal morbidity and
      mortality. The association of milder forms of gestational diabetes with adverse pregnancy
      outcomes, including morbidities such as macrosomia, birth trauma, and neonatal hypoglycemia,
      remains questionable. While it is likely that maternal glucose intolerances reflect a
      continuum of risk for adverse outcomes, it is not known whether there is a benefit to
      identification and subsequent treatment of mild glucose intolerance during pregnancy. This
      study will determine whether dietary treatment (and insulin as required) for mild GDM will
      reduce the frequency of neonatal morbidity associated with mild glucose intolerance.

      Participants in this study will receive a 50-gram glucose loading test (GLT) between 24 and
      30 weeks' gestation. Those with a positive GLT will receive a subsequent 3-hour oral glucose
      tolerance test (OGTT). Based upon these test results, women will be assigned to 4 groups.
      Women with a positive GLT and abnormal OGTT will be randomly assigned to receive either
      nutritional counseling and diet therapy (Group 1) or no specific treatment (Group 2a). Women
      with a positive GLT but normal OGTT will be enrolled in Group 2b for observation. Women with
      a negative GLT will be enrolled in Group 3 and will serve as a control group.

      Women in Group 1 will receive formal nutritional counseling and will be instructed on the
      techniques of self blood glucose monitoring. Patients will take daily blood glucose
      measurements and will be seen at weekly study visits. The study will evaluate birth outcomes,
      including stillbirth, neonatal hypoglycemia, neonatal hyperinsulinemia, neonatal
      hyperbilirubinemia, and birth trauma.

      The follow-up study will examine if blood sugar levels and treatments during pregnancy
      influence the health of the mother and child several years later. The study will also examine
      whether there is a genetic link to the health of the mother and child. The study visit will
      include blood pressure, body size measurements, blood draw and saliva collection, and
      questions related to the mother and child's health and environment.
    

Intervention name(s): nutritional counseling; self blood glucose monitoring
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild gestational diabetes mellitus; Maternal Fetal Medicine Units Network