Observational Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy to Assess the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of MCM
研究概览
简要总结
The purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to Epidiolex/Epidyolex during pregnancy and their infant up to 12 months of life.
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
- •Patients with exposure to at least 1 dose of Epidiolex/Epidyolex during the 13 days prior to their LMP or at any time during pregnancy.
- •Verbal or written informed consent to participate
排除标准
- •1) Patients exposed to a non-regulatory approved product containing Cannabidiol (CBD) during pregnancy who do not also have exposure to Epidiolex during the 13 days prior to their LMP or during the pregnancy.
研究组 & 干预措施
Retrospective Pregnancy
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is no longer pregnant at the time of study enrollment.
干预措施: Epidiolex (Drug)
Prospective Pregnancy
Participants who were exposed to at least one dose of Epidiolex/Epidyolex in routine practice during the 13 days prior to last menstrual period (LMP) or at any time during their pregnancy and is pregnant at the time of study enrollment.
干预措施: Epidiolex (Drug)
结局指标
主要结局
Rate of MCM
时间窗: Up to 12 months post birth
Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age
次要结局
- Rate of pregnancy outcomes(Up to 10 months gestation)
- Rate of maternal complications during pregnancy(Up to 10 months gestation)
- Rate of other events of interest in the developing neonate and infant(Up to 12 months post birth)