Gestational Diabetes Mellitus Trial (GDM)

Completed · Not applicable

Conditions studied: Diabetes, Gestational

In brief

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.

Key facts

Study ID

NCT00069576

Run by

The George Washington University Biostatistics Center

People needed

7381

Starts

2002-10-01

Expected to finish

2013-10-01

Last updated by the study team

2019-07-15

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant
• Gestational age at enrollment 24 - 31 weeks

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Northwestern University — Chicago, Illinois, United States
• Wayne State University - Hutzel Hospital — Detroit, Michigan, United States
• Columbia University-St. Luke's Hospital — New York, New York, United States
• University of North Carolina-Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Ohio State University Hospital — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Brown University — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Texas-Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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