Conditions: Mild Gestational Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 395
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 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. arm 2: Women with mild gestational diabetes will be started ADA diet and placebo.

Interventions: intervention 1: Glyburide intervention 2: Placebo
Intervention descriptions: intervention 1: Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control. intervention 2: Sham dose adjustments of the placebo will be made.

Protocol document: