Cimzia (certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 925
- 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 Diseases 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 five years 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 which 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.
详细描述
The purpose of the OTIS Autoimmune Diseases in Pregnancy Project, Cimzia Pregnancy Exposure Registry is to follow pregnant women with or without a Cimzia approved indication who have or have not been treated with Cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.
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: Duration of 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.
次要结局
- Minor malformations(At dysmorphological exam which will occur at one time point between birth and 5 years of age)
- Pregnancy Outcome(Duration of pregnancy and up to 1 year of life)
- Infant follow-up(Duration of pregnancy and up to 5 years of life)
研究者
Christina Chambers
Professor, Co-Director Center for Promotion of Maternal Health and Infant Development
University of California, San Diego