DRKS00032881已完成不适用
Observational cohort study of pregnancy outcomes after intrauterine exposure to clindamycin based on the Embryotox cohort
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie0 个研究点目标入组 400 人开始时间: 2024年1月3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
- 400
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 study cohorts: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact. First contact with the Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy, Berlin during the study period 01.01.2000- 31.07.2023. Information on the outcome of pregnancy is completed. The quality of the information/data must comply with internal standards.
排除标准
- •Exclusion criteria (applies for the exposed cohort and the control cohorts):
- •-Malignant diseases
- •-Exposure to proven teratogens [acenocoumarol, carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalene, alitretinoin, isotretinoin, tazarotene, tretinoin, trifarotene), topimarate, thalidomide, valproic acid, warfarin]; Exposure to fetotoxic substances in the second and/or third trimester [angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists]
- •-Topical/cutaneous application of clindamycin (exception: vaginal application)
- •-Indication for clindamycin treatment due to pathological pregnancy complications (e.g. preterm labour, premature rupture of membranes) caused by infection in late pregnancy
- •-Insufficient data on pregnancy outcome or non-plausible, missing relevant data
研究者
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