DRKS00007621尚未招募不适用
Pregnancy outcome after first-trimester exposure to metformin: the experience of the Berlin institute for clinical teratology and drug risk assessment in pregnancy
Pharmakovigilanz- und Beratungszentrum für EmbryonaltoxikologieCharité - Universitätsmedizin Berlin0 个研究点目标入组 1,500 人开始时间: 2015年8月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 one（—）
- 性别
- Female
入选标准
- •Both cohorts: prospectively ascertained pregnancies, i.e. outcome of pregnancy is unknown at the time of contact to the study centre; study cohort: metformin exposure during the first trimester of pregnancy; control cohort: control group without metformin therapy
排除标准
- •malignancies, exposure to established teratogens (lenalidomide, carbamazepine, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topiramate, warfarin) or fetotoxicants (angiotensin-converting enzyme (ACE)-inhibitors and angiotensin II receptor antagonists) after the first trimester; valproaic acid-exposed pregnancies will be evaluated separately (patients may be prone to PCOS)
研究者
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