UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Women's Studies, Epilepsy |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2004 |
| End Date: | March 2016 |
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
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).
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).
Inclusion Criteria:
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)
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