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临床试验/DRKS00015636
DRKS00015636已完成不适用

Evaluation of pregnancy outcomes after maternal first trimester exposure to valproate and analysis of embryotoxic risks - Valproate during pregnancy

Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin0 个研究点目标入组 484 人开始时间: 2018年10月23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
484

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

  • For both cohorts: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact. An analysis of these prospectively ascertained pregnancies can therefore be used for risk quantification of the defined endpoints.

排除标准

  • Maternal malignancies in both cohorts. For the control cohort maternal exposure to substances considered as potent teratogens or fetotixicants, i.e. acenocoumarol, ACE-inhibitors and AT1-antagonists (exposure in 2nd and 3rd trimester), carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topimarat, valproate, warfarin.

研究者

发起方
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin

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