DRKS00007620已完成不适用
Investigation of embryotoxic effects of maternal therapy with vitamin k antagonist phenprocoumon in pregnancy: the experience of the Embryotox- database - Phenprocoumon in pregnancy
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie; Charité Universitätsmedizin0 个研究点目标入组 409 人开始时间: 2015年9月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 409
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
- •Prospectively ascertained pregnancies.
- •Study cohort
- •Prospectively ascertained pregnancies with maternal phenprocoumon therapy.
- •Exposure interval at least 32 days before conception (2 weeks + 4 days before the first day of the last menstrual period (LMP)) and week 12+6 days after LMP. Therapy may have started earlier and can have lasted longer.
- •Control group
- •Prospectively ascertained pregnancies without phenprocoumon or other coumarin- derivates (acenocoumarol, warfarin, coumadine) exposure during any time in pregnancy.
排除标准
- •Exclusion criteria are women with acute malignancies, with tumors, with seizures (except preeclampsia) and cases with maternal exposure to the following drugs considered as major teratogens or fetotoxicants:
- •carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topiramate, valproic acid, angiotensin-converting enzyme (ACE)-inhibitors and angiotensin II receptor antagonists.
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