Humira (adalimumab) Pregnancy Exposure Registry: OTIS Rheumatoid Arthritis in Pregnancy Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 944
- 试验地点
- 1
- 主要终点
- Major malformations
研究概览
简要总结
The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently pregnant
排除标准
- 未提供
结局指标
主要结局
Major malformations
时间窗: Throughout pregnancy and up to 1 year of life
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects of newborns.
次要结局
- Pregnancy outcome(Throughout pregnancy)
- Infant follow-up(Throughout pregnancy and up to 1 year of life)
- Minor malformations(At dysmorphological exam)
研究者
Christina Chambers
Principal Investigator, Professor Department of Pediatrics
University of California, San Diego