Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Treatment failure
研究概览
简要总结
This study aims to compare the maternal, fetal, and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes.
The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy.
详细描述
Primary Outcome: treatment failure is defined as the initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects.
Secondary Outcomes:
Maternal:
- Percentage of fasting and postprandial glucose levels within target levels after initiation of treatment
- Incidence of maternal hypoglycemia
- Reported maternal side effects
- Maternal weight gain
- Preterm delivery
- Development of pregnancy-induced hypertension
- Labor dystocia.
- Instrumental delivery and its indication (fetal compromise, delay in progress, or maternal exhaustion)
- Mode of delivery
- Incidence of third and fourth perineal tear
Fetal and neonatal:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women over 18 years old.
- •Gestational age between 24 - 28 weeks.
- •New diagnosis of gestational diabetes mellitus using a 2-hour glucose tolerance test.
- •Medical therapy is indicated to control blood glucose following the failure of diet and lifestyle changes to solely achieve glycemic control (A2GDM).
排除标准
- •Patients with pre-gestational diabetes.
- •First trimester fasting blood glucose ≥105 mg/dl or HbA1c > 6.4%.
- •Major fetal anomalies.
- •Intrauterine growth restriction (IUGR) before 24 weeks.
- •Abnormal renal or liver function.
- •Contraindications to metformin or glyburide.
- •Medical treatment declined by the patient.
- •Direct indication to commence insulin (initial fasting blood glucose >= 7 mmol/l or 126 mg/dl or >= 6 mmol/l or 108 mg/dl with macrosomia or polyhydramnios).
- •Significant medical co-morbidities requiring continuous medical treatment in pregnancy.
- •Non-compliance to blood glucose self-monitoring (missing 50% or more of total readings)
研究组 & 干预措施
Metformin
Metformin (500 to 2000 mg orally)
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
Glyburide
Glyburide (2.5 mg to 20 mg orally)
干预措施: GlyBURIDE 2.5 MG Oral Tablet (Drug)
结局指标
主要结局
Treatment failure
时间窗: From 28 weeks till 41 weeks of pregnancy
Initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects
次要结局
- Incidence of maternal hypoglycemia(From 28 weeks till 41 weeks of pregnancy)
- Significant side effects(From 28 weeks till 41 weeks of pregnancy)
- Fetal macrosomia (large for gestational age)(32 weeks of gestation to onset of labour)
研究者
Sherif Abdelkarim Mohammed Shazly
Senior clinical fellow
Middle-Eastern College of Obstetricians and Gynecologists