Parkland Memorial Hospital
Dallas, Texas, 75235, United States
NCT Number: NCT00744965
This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.
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Notify Me16 year–45 year
Female
Interventional
Phase 4
Dallas, Texas, 75235, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Sham dose adjustments of the placebo will be made.
Time frame: Immediately after delivery of fetus
Time frame: After delivery
Birth weight exceeding the 90th percentile for the gestational age at delivery.
Time frame: After delivery
birth weight 4,000 g or greater
Time frame: Until hospital discharge
Time frame: After delivery
Time frame: until hospital discharge
Time frame: at delivery
Time frame: after delivery
Time frame: at delivery
Time frame: intrapartum
Maternal fever >=38.0°C
Time frame: throughout pregnancy and delivery
University of Texas Southwestern Medical Center
Other
A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.