A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Women Exposed to Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Major congenital malformations (MCM)
研究概览
简要总结
Bempedoic acid pregnancy surveillance program
详细描述
A surveillance study of females exposed to bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product (FCDP) during pregnancy. Observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（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 bempedoic acid or bempedoic acid/ezetimibe FCDP at any time during pregnancy (from first day of last menstrual period [LMP] to pregnancy outcome
排除标准
- 未提供
结局指标
主要结局
Major congenital malformations (MCM)
时间窗: Birth up to 12 months
An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention (CDC 2019a). MCMs will be defined and coded with criteria specified by US CDC Metropolitan Atlanta Congenital Defects Program (MACDP).
次要结局
- Minor congenital malformation(Birth up to 12 months)
- Spontaneous abortion(Time of conception up to birth)
- Stillbirth(Time of conception up to birth)
- Elective termination(Time of conception up to birth)
- Preterm birth(Time of conception up to birth)
- Small for gestational age (SGA)(Birth up to 12 months)
- Infant development deficiency(Birth up to 12 months)
- Postnatal growth deficiency(Birth up to 12 months)