EUCTR2014-001244-38-GB进行中（未招募）不适用
Preventing Recurrent Gestational Diabetes Mellitus with Early Metformin Intervention - Preventing Recurrent Gestational Diabetes with Metformin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Confirmed singleton viable pregnancy
- •2. Between 8 and 22 weeks gestation
- •3. History of a previous pregnancy complicated by gestational diabetes mellitus
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Established pre-existing diabetes (including unrecognised diabetes defined as FPG = 7.0mmol/L and/ or HbA1c = 48mmol/mol)
- •2. Contraindications to metformin therapy
- •a. Renal impairment: creatinine = 130µmol/L
- •b. Impaired liver function (ALT = 2.0 x upper limit normal)
- •c. Previous intolerance to metformin
- •3. Planned continued antenatal care/ delivery at centre not included in trial
- •4. Planned fast for cultural/ religious reasons e.g. Ramadan
研究者
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