Avonex Pregnancy Exposure Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 329
- 试验地点
- 1
- 主要终点
- Record and analyze birth defects and spontaneous fetal losses
研究概览
简要总结
The primary objectives of the study were to prospectively record and analyze birth defects and spontaneous fetal losses in women with multiple sclerosis (MS) exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy, where the outcome of the pregnancy was unknown prospectively and to prospectively record and analyze pregnancy outcomes in an exploratory fashion of women with MS who stopped therapy, but who may have been exposed to Avonex with approximately 1 week of conception or during the first trimester of pregnancy.
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
- •Have been exposed to AVONEX within approximately 1 week of conception or during the first trimester of pregnancy.
- •Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively).
- •Provide verbal consent to participate in the Registry.
- •Verbally provide contact information for herself, her HCP, and the infant's HCP (if applicable).
- •NOTE: Other protocol defined inclusion/exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Pregnant participants
Pregnant participants who were exposed to Avonex within approximately 1 week of conception or during the first trimester of pregnancy
干预措施: BG9418 (interferon beta-1a) (Drug)
结局指标
主要结局
Record and analyze birth defects and spontaneous fetal losses
时间窗: Prospectively, MS women exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
Record and analyze pregnancy outcomes
时间窗: Prospectively, MS women who stopped therapy, but may have been exposed to Avonex within 1 week of conception or during the first trimester of pregnancy
次要结局
未报告次要终点