Clinical Trial: Gestational Diabetes Mellitus Trial (GDM)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus

Brief 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 Summary:

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
Sponsor: The George Washington University Biostatistics Center

Current Primary Outcome:

  • Composite neonatal morbidity (hypoglycemia, hyperinsulinemia, hyperbilirubinemia, birth trauma, neonatal mortality; death or stillbirth [ Time Frame: Delivery ]
  • death or stillbirth [ Time Frame: Delivery ]


Original Primary Outcome:

  • - Composite neonatal morbidity (hypoglycemia, hyperinsulinemia, hyperbilirubinemia, birth trauma)
  • - death or stillbirth


Current Secondary Outcome:

  • large for gestational age [ Time Frame: Delivery ]
  • macrosomia (birth weight > 4000 gm) [ Time Frame: Delivery ]
  • delivery route [ Time Frame: Delivery ]
  • neonatal fat mass [ Time Frame: Delivery ]
  • neonatal mortality and morbidity [ Time Frame: Delivery ]


Original Secondary Outcome:

  • - large for gestational age
  • - macrosomia (birth weight > 4000 gm)
  • - delivery route
  • - neonatal fat mass
  • - neonatal mortality and morbidity


Information By: The George Washington University Biostatistics Center

Dates:
Date Received: September 29, 2003
Date Started: October 2002
Date Completion:
Last Updated: October 19, 2015
Last Verified: October 2015