INC Research
Wilmington, North Carolina, 28405, United States
NCT Number: NCT00345475
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).
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Observational
Wilmington, North Carolina, 28405, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The subjects must meet the following criteria for registration:
Time frame: 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.
UCB Pharma
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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