A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Mean Fetal Weight at Birth
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
- •An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
- •Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
- •Singleton gestation
排除标准
- •Established pregestational diabetes
- •Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
- •Multiple gestations
- •Known major fetal anomaly or fetal demise
- •Any renal disease with serum creatinine of >1.0
- •Known liver disease such as hepatitis
- •Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction
- •Known hypersensitivity or allergic reaction to Glyburide
研究组 & 干预措施
Glyburide
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.
干预措施: Glyburide (Drug)
Placebo
Women with mild gestational diabetes will be started ADA diet and placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Fetal Weight at Birth
时间窗: Immediately after delivery of fetus
次要结局
- Number of Participants With Large for Gestational Age Infants(After delivery)
- Macrosomia(After delivery)
- Neonatal Intensive Care Unit Admissions(Until hospital discharge)
- Rate of Cesarean Delivery(After delivery)
- Diagnosis of Pregnancy-induced Hypertension(until hospital discharge)
- Shoulder Dystocia(at delivery)
- Need for Insulin Treatment(after delivery)
- 3rd or 4th Degree Perineal Laceration(at delivery)
- Chorioamnionitis(intrapartum)
- Need for Insulin Therapy(throughout pregnancy and delivery)
研究者
Kenneth Leveno
Professor
University of Texas Southwestern Medical Center