DRKS00004864已完成不适用
Are fluoroquinolones teratogenic in humans? Evaluation of the Embryotox patient-database
Pharmakovigilanzzentrum EmbryonaltoxikologieCharité-Universitätsmedizin0 个研究点目标入组 4,745 人开始时间: 2013年4月5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
- 4,745
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: Prospectively ascertained pregnancies, i.e. neither the outcome of pregnancy nor results of prenatal diagnostics are primarily known, but are ascertained at a later stage.
- •Study group (Fluoroquinolone exposed pregnancies): Pregnant women, who had a systemic exposure to fluoroquinolones (oral or intravenous) between gestational week 2+0 and 12+6 after last menstrual period.
- •Control group: Pregnant women, who were neither exposed to fluoroquinolones nor strong teratogenic or fetotoxic substances. The control group is matched with the study group for year of enrolment.
排除标准
- •Exclusion criteria for the control group are cancer or seizures except preklampsia. Furthermore, the exposure to one of the following substances is an exclusion criteria: Acitretin, carbamazepine, isotretinoin, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, valproic acid, warfarin, ACE inhibitors, angiotensin II receptor antagonist.
研究者
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