Fampridine Pregnancy Exposure Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Maternal death
研究概览
简要总结
This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.
详细描述
There are no mandatory physician visits. The registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post 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
- •Documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.)
- •The outcome of the pregnancy must not be known at the time of report.
排除标准
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Maternal death
时间窗: During pregnancy, labor or delivery
Elective or therapeutic terminations
时间窗: Up to 9 months of pregnancy
Fetal death including still births
时间窗: >22 weeks of gestation or weighing 500 grams
Live born infants
时间窗: During delivery time ( at expected average 9 months of pregnancy)
Neonatal death
时间窗: Prior to 28 days of life
Birth Defects
时间窗: Delivery time (expected 9 months of pregnancy)
Ectopic pregnancy
时间窗: Up to 9 months of pregnancy
Spontaneous abortions
时间窗: < 22 weeks of gestation
Premature births
时间窗: Delivered before 37 Weeks of gestation
次要结局
未报告次要终点