UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00345475|
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : September 2, 2016
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).
|Condition or disease|
|Birth Defects Pregnancy Complications Epilepsy Seizures|
|Study Type :||Observational|
|Actual Enrollment :||516 participants|
|Official Title:||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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Women being treated with UCB AEDs while pregnant.
- The number of birth defects reported and confirmed by a teratologist [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345475
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28405|
|Principal Investigator:||Vikki Brown, MD||Syneos Health|
|Study Director:||Jürgen Bentz, PhD||UCB Pharma|