Home | | | Search | | | Browse | | | Resources | | | Help | | | What's New | | | About |
---|
Gestational Diabetes Mellitus Trial
This study is currently recruiting patients.
Sponsored by: | National Institute of Child Health and Human Development (NICHD) |
---|---|
Information provided by: | National Institute of Child Health and Human Development (NICHD) |
Purpose
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 with mild GDM improves the health of their babies.
Condition | Treatment or Intervention |
---|---|
Diabetes, Gestational |
Behavior: nutritional counseling Behavior: self blood glucose monitoring |
MedlinePlus related topics: Diabetes and Pregnancy
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
Expected Total Enrollment: 2375
Study start: October 2002
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.
Eligibility
Ages Eligible for Study: 18 Years - 50 Years, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
Inclusion Criteria
Exclusion Criteria
Location and Contact Information
More Information
Publications
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |