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Gestational Diabetes Mellitus Trial (GDM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00069576
First received: September 29, 2003
Last updated: November 15, 2013
Last verified: September 2012
  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. 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.


Condition Intervention
Diabetes, Gestational
Behavioral: nutritional counseling
Behavioral: self blood glucose monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus

Resource links provided by NLM:


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, neonatal mortality; death or stillbirth [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • death or stillbirth [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • large for gestational age [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • macrosomia (birth weight > 4000 gm) [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • delivery route [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • neonatal fat mass [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • neonatal mortality and morbidity [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Enrollment: 1889
Study Start Date: October 2002
Study Completion Date: October 2013
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nutritional counseling & self blood glucose monitoring
Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter.
Behavioral: nutritional counseling Behavioral: self blood glucose monitoring
No Intervention: No treatment
This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University - Hutzel Hospital
Detroit, Michigan, United States, 48201
United States, New York
Columbia University-St. Luke's Hospital
New York City, New York, United States, 10032
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 17599
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44109
Ohio State University Hospital
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
University of Texas Medical Branch
Galveston, Texas, United States, 77555
University of Texas-Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Investigators
Study Chair: Mark B. Landon, MD Ohio State University
Study Director: Uma Reddy, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth A Thom, Ph.D. George Washington University Biostatistics Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00069576     History of Changes
Other Study ID Numbers: HD36801 - GDM, U10HD021410, U10HD027869, U10HD027917, U10HD027915, U10HD034116, U10HD034208, U10HD040500, U10HD040485, U10HD040544, U10HD040545, U10HD040560, U10HD040512, U01HD036801, U10HD053118, U10HD053097, U10HD027860
Study First Received: September 29, 2003
Last Updated: November 15, 2013
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on July 22, 2014