A Prospective Study Of Pregnancies Exposed to UCB Antiepileptic Drugs to Determine if There is a Potential Increase in the Risk of Major Birth Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- The number of birth defects reported and confirmed by a teratologist
研究概览
简要总结
This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra XR® in order to determine if there is a potential increase in the risk of major birth defects compared to rates from women in the general US population.
The objectives of the UCB AED Pregnancy Registry are:
- To prospectively collect data concerning 1) exposure to Keppra® and Keppra XR® during pregnancy, 2) potential confounding factors, 3) outcome of pregnancy, and 4) long-term pediatric outcome
- To review reported cases of possible birth defects
- To estimate the risk of birth defects occurring in live-born offspring of women exposed to Keppra® and Keppra XR® during pregnancy
This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subjects must meet the following criteria for registration:
- •Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
- •Exposure to Keppra® and Keppra XR® on or after the first day of the patient's last menstrual period (verified by date or gestational age of exposure)
- •For patient-initiated enrollments, provide verbal or written consent to participate in the Registry
- •For patient-initiated enrollments, provide contact information for herself, her HCP, and the infant's HCP (as applicable)
排除标准
- 未提供
结局指标
主要结局
The number of birth defects reported and confirmed by a teratologist
时间窗: Throughout pregnancy and up to 3 years of life
The purpose of the UCB AED Pregnancy Registry is to monitor pregnancies exposed to UCB AEDs to determine if there is a potential increase in the risk of major birth defects.
次要结局
未报告次要终点