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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00069576 |
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 who have mild GDM improves the health of their babies.
| Condition | Intervention |
|---|---|
|
Diabetes, Gestational |
Behavioral: nutritional counseling Behavioral: self blood glucose monitoring |
| 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 |
| Enrollment: | 1889 |
| Study Start Date: | October 2002 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
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 to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| Wayne State University - Hutzel Hospital | |
| Detroit, Michigan, United States | |
| United States, New York | |
| Columbia University-St. Luke's Hospital | |
| New York City, New York, United States | |
| United States, North Carolina | |
| University of North Carolina-Chapel Hill | |
| Chapel Hill, North Carolina, United States | |
| United States, Ohio | |
| Ohio State University Hospital | |
| Columbus, Ohio, United States, 43210 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| University of Pittsburgh-Magee Womens Hospital | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Rhode Island | |
| Brown University | |
| Providence, Rhode Island, United States | |
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States | |
| University of Texas-Houston | |
| Houston, Texas, United States | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States | |
| Study Chair: | Mark B. Landon, MD | Ohio State University |
More Information
| Responsible Party: | Pregnancy and Perinatology Branch, NICHD, NIH ( Catherine Y Spong, MD, Chief ) |
| Study ID Numbers: | 2U10HD027915, HD21410, HD27869, HD27917, HD27915, HD34116, HD34208, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512, HD36801, HD53118, HD53097 |
| Study First Received: | September 29, 2003 |
| Last Updated: | October 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00069576 History of Changes |
| Health Authority: | United States: Federal Government |
|
Mild gestational diabetes mellitus Maternal Fetal Medicine Units Network |
|
Pregnancy Complications Metabolic Diseases Diabetes Mellitus |
Endocrine System Diseases Diabetes, Gestational Glucose Metabolism Disorders |