跳至主要内容
临床试验/DRKS00029177
DRKS00029177Enrolling By Invitation不适用

Pregnancy outcome after 1st trimester exposure to statins - an evaluation based on the Embryotox cohort database

Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum,0 个研究点目标入组 840 人开始时间: 2022年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
840

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. First contact during the study period 01.01.2000- 30.06.2021. Information on the outcome of pregnancy is completed. The quality of the information/data must comply with internal standards.

排除标准

  • Malignancies; Cases with maternal exposure to considered potent teratogens or fetotoxicants: i.e. valproate, topiramate and carbamazepine as well as acenocoumarol, ACE-inhibitors and AT1- antagonists (exposure in 2nd and 3rd trimester), lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide and warfarin.
  • Missing data on pregnancy outcome.

研究者

发起方
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum,

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