NCT01087125已完成不适用
Abatacept Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project: An Extension Study
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2006年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Major structural birth defects of newborns
研究概览
简要总结
The purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth.
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
- 否
入选标准
- •Currently pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants
排除标准
- •Women who come in first contact with the project after prenatal diagnosis of a fetal abnormality
研究组 & 干预措施
Pregnant RA patients with abatacept exposure during pregnancy
干预措施: No Interventions (Drug)
结局指标
主要结局
Major structural birth defects of newborns
时间窗: Throughout pregnancy and up to 1 year of life
次要结局
- 3 or more minor structural defects(at dysmorphological exam)
- Small for gestational age(at birth)
- Spontaneous abortion(throughout pregnancy)
- Postnatal serious infections, hospitalizations or malignancies(1st year of life)
- Postnatal growth deficiency(throughout pregnancy and up to 1 year of life)
- Premature delivery(throughout pregnancy)
研究者
研究点 (1)
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