The Mycophenolate Pregnancy Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Fetal Outcomes: Incidence of Congenital Disorders
研究概览
简要总结
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified.
This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.
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
- •Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
排除标准
- •Pregnancies for which there is paternal exposure only
- •Pregnancies occurring outside the U.S.
研究组 & 干预措施
Pregnant Patients Exposed to Mycophenolate
结局指标
主要结局
Fetal Outcomes: Incidence of Congenital Disorders
时间窗: Approximately 13 years
Time/Duration of Mycophenolate Exposure
时间窗: Approximately 13 years
Maternal Medical/Demographic Characteristics
时间窗: Approximately 13 years
Maternal Outcomes: Incidence of Pregnancy Complications
时间窗: Approximately 13 years
Indications for Mycophenolate use
时间窗: Approximately 13 years
Mycophenolate Dose/Regimen
时间窗: Approximately 13 years
次要结局
- Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy(Approximately 13 years)