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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
395
Parkland Memorial Hospital
Dallas, Texas, United States
Mean Fetal Weight at Birth
Time frame: Immediately after delivery of fetus
Number of Participants With Large for Gestational Age Infants
Birth weight exceeding the 90th percentile for the gestational age at delivery.
Time frame: After delivery
Macrosomia
birth weight 4,000 g or greater
Time frame: After delivery
Neonatal Intensive Care Unit Admissions
Time frame: Until hospital discharge
Rate of Cesarean Delivery
Time frame: After delivery
Diagnosis of Pregnancy-induced Hypertension
Time frame: until hospital discharge
Shoulder Dystocia
Time frame: at delivery
Need for Insulin Treatment
Time frame: after delivery
3rd or 4th Degree Perineal Laceration
Time frame: at delivery
Chorioamnionitis
Maternal fever \>=38.0°C
Time frame: intrapartum
Need for Insulin Therapy
Time frame: throughout pregnancy and delivery
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