ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Gestational Diabetes Mellitus Trial

This study is ongoing, but not recruiting participants.

Sponsored by: 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

MedlinePlus related topics:   Diabetes   

Drug Information available for:   Dextrose   

U.S. FDA Resources

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

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Composite neonatal morbidity (hypoglycemia, hyperinsulinemia, hyperbilirubinemia, birth trauma)
  • death or stillbirth

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

Enrollment:   1889
Study Start Date:   October 2002
Estimated Study Completion Date:   July 2008
Primary Completion Date:   February 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria

  • Pregnant
  • Gestational age at enrollment 24 - 31 weeks

Exclusion Criteria

  • Diabetes diagnosed prior to pregnancy
  • Abnormal gestational diabetes (>= 135 mg/dl) testing prior to 24 weeks' gestation
  • Gestational diabetes in a previous pregnancy
  • History of stillbirth or fetal death
  • Pregnancy with more than one fetus
  • Known major fetal anomaly
  • Current or planned corticosteroid therapy
  • Asthma requiring medication
  • Current or planned beta adrenergic therapy
  • Chronic hypertension requiring medication within 6 months of or during pregnancy
  • Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
  • Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
  • Maternal or fetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labor, or intrauterine growth retardation
  • Previous or planned tocolytic therapy to induce labor or increase contraction strength
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069576

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

Sponsors and Collaborators

Investigators
Study Chair:     Mark B. Landon, MD     Ohio State University    
  More Information


NICHD Maternal Fetal Medicine Units Network website  This link exits the ClinicalTrials.gov site
 

Publications:

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
First Received:   September 29, 2003
Last Updated:   May 21, 2008
ClinicalTrials.gov Identifier:   NCT00069576
Health Authority:   United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Mild gestational diabetes mellitus  
Maternal Fetal Medicine Units Network  

Study placed in the following topic categories:
Pregnancy Complications
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetes, Gestational
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers