Mavacamten Pregnancy Surveillance Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pregnancy outcomes
研究概览
简要总结
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first)
- •At least 15 years of age or older at the time of enrollment
- •Informed consent or institutional review board/ethics committee-approved waiver of informed consent
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Pregnant or breastfeeding women exposed to mavacamten
干预措施: Mavacamten (Drug)
结局指标
主要结局
Pregnancy outcomes
时间窗: Up to 10 months
(1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications
Fetal/neonatal/infant outcomes
时间窗: Up to 12 months post pregnancy outcome
Number of fetal/neonatal/infants in utero, at birth, and through the first year of life with major and minor congenital malformations, small for gestational age, premature delivery, and post-natal growth and development deficiency
次要结局
未报告次要终点