ISRCTN51279843已完成3 期
A multicentre randomised placebo controlled clinical trial of metformin versus placebo in pregnant women to reduce the risk of obesity and metabolic syndrome in their babies
niversity of Edinburgh and NHS Lothian (UK)0 个研究点目标入组 400 人开始时间: 2010年6月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Caucasian obese (body mass index [BMI] greater than or equal to 30 kg/m^2) pregnant women between 12-0 and 16+0 weeks gestation
- •2. Women aged greater than 16 years
- •3. Signed informed consent form
排除标准
- •1. Non Caucasian women
- •2. Women with a BMI less than or equal to 29 kg/m^2
- •3. Gestation greater than than 16 weeks
- •4. Women with pre-existing diabetes
- •5. Women with gestational diabetes in a previous pregnancy
- •6. Women with systemic disease requiring regular medication
- •7. Gestational diabetes in index pregnancy (diagnosed with 75 g oral glucose tolerance test [OGTT] prior to randomisation)
- •8. Previous delivery of a baby less than 3rd centile or previous pregnancy with pre-eclampsia prompting delivery before 32 weeks gestation
- •9. A known hypersensitivity to metformin hydrochloride or to any of the excipients
- •10. Known abnormalities of the liver (tested prior to randomisation)
- •11. Renal failure or renal dysfunction
- •12. Acute conditions with the potential to alter renal function such as:
- •12.1. Dehydration sufficient to require intravenous infusion
- •12.2. Severe infection
- •12.3. Shock
- •12.4. Intravascular administration of iodinated contrast agents
- •12.5. Acute or chronic diseases which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock or hepatic insufficiency, acute alcohol intoxication or alcoholism
- •13. Lactation
- •14. Multiple pregnancy
研究者
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