DRKS00003328已完成不适用
Is there an increased risk for adverse pregnancy outcome after exposure to low-dose methotrexate (MTX) during early pregnancy? A prospective multicenter cohort study.
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie; Charité Universitätsmedizin0 个研究点目标入组 1,890 人开始时间: 2012年1月18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
- 1,890
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 all 3 cohorts: prospectively ascertained pregnancies, i.e. neither the outcome of pregnancy nor the results of prenatal diagnostics are primarily known, but are ascertained at a later stage.
- •Study group
- •Includes cases with low dose MTX, <=30 mg/week. Cases with more than 30 mg/week will be evaluated separately. MTX exposure time meets the period from 3 months pre-conception until week 12 after LMP. Exposure time may have started before 3 months preconception and continued beyond week 12.There is no limit of treatment duration during pregnancy. (Usually the treatment is stopped after recognition of pregnancy, which e.g. could be in week 20). A single dose of MTX is sufficient for study inclusion, as long as the single dose was not received earlier than one month before conception (in the preconception subgroup).
- •Control group 1 (Disease group”)
- •Includes cases with rheumatoid arthritis or other autoimmune diseases either without medication or with other immunomodulatory/immunosuppressive drugs than MTX. (e.g. MedDRA HLT code 10039078: rheumatoid arthropathies, HLT-code 10025135: lupus erythematosus (incl. subtypes), PT-code 10002817: antiphospholipid-syndrome, HLT-code 10065874: psoriatic conditions, PT-code 10011401: Crohn ‘s disease, PT 10047115: Vasculitis; ICD-10 (2010: http://www.lumrix.de/icd.php): D68.6, K50; M05-M09; M32-36). Matched with study group for year of counseling and treatment indication (disease) and recruiting country.
- •Control group 2 (General controls”)
- •Matched with study group for year of counseling and recruiting country.
排除标准
- •For all three cohorts:
- •Excludes cases with exposure to following medication that is considered as major teratogen or major fetotoxicant:Acitretin, Isotretinoin,
- •Mycophenolate,Thalidomide, Valproic acid,
- •Angiotensin-II receptor blockers (sartanes) (only when used in 2nd or 3rd trimester) and
- •ACE inhibitors (only when used in 2nd or 3rd trimester)
- •Excludes cases with the following treatment indication: Malignancies (MedDRA code: Malignant or unspecified tumors (SMQ 20000091) ), ICD-10: C00-D09). Malignancy related conditions (MedDRA: SMQ 20000092), ICD-10: C00-D09)
- •Control group 1 (Disease group”):
- •Excludes cases with exposure to MTX
- •Control group 2 (General controls):
- •Excludes cases with exposure to MTX and cases with exposure to Immunomodulatory/immunosuppressive drugs (Exception: corticosteroids).
研究者
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