Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00744965|
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mild Gestational Diabetes||Drug: Glyburide Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||395 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2016|
Active Comparator: 1
Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
Placebo Comparator: 2
Women with mild gestational diabetes will be started ADA diet and placebo.
Sham dose adjustments of the placebo will be made.
- Fetal weight reduction of 200gm with Glyburide treatment [ Time Frame: Immediately after delivery of fetus ]
- Large for gestational age infants [ Time Frame: After delivery ]
- Macrosomia [ Time Frame: After delivery ]
- Neonatal Intensive Care Unit admissions [ Time Frame: Until hospital discharge ]
- Rate of cesarean delivery [ Time Frame: After delivery ]
- Risk of preeclampsia [ Time Frame: until hospital discharge ]
- Time to achieve glycemic control [ Time Frame: after delivery ]
- Need for insulin treatment [ Time Frame: after delivery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744965
|United States, Texas|
|Parkland Memorial Hospital|
|Dallas, Texas, United States, 75235|