EUCTR2011-002203-15-SE进行中（未招募）1 期
Metformin treatment of pregnant PCOS women and prevention of late miscarriages and preterm birthThe PregMet 2 Study - PregMet 2
TNU, Norwegian University of Science and Technology0 个研究点目标入组 1,000 人开始时间: 2012年6月26日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
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
- •Inclusion criteria
- •Age: 18-45 years
- •PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion.
- •Mode of conception: Any
- •Single, viable fetus, diagnosed by vaginal ultrasound
- •Gestational week at inclusion: week 6 + 0 to 12 + 0.
- •Wash out for metformin: at least 7 days
- •Able to communicate fluently in the official language at the study cite or English
- •Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Any type of diabetes (except GDM in former pregnancy).
- •Known liver disease or ALAT > 100 IU/L
- •Known kidney disease or creatinine > 110 µmol/L
- •Known alcohol or drug abuse
- •Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidin, anticoagulation therapy
- •Unsuitable for participation of other reasons
- •Participating in other medical trials in the same period of time
研究者
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