UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)

Completed

• Conditions: Pregnancy Complications; Seizures; Birth Defects; Epilepsy

• Registration Number: NCT00345475
• Lead Sponsor: UCB Pharma

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2006-06-26
• Study First Submitted QC: 2006-06-26
• Study First Posted: 2006-06-28
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 516

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of birth defects reported and confirmed by a teratologist	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.

Trial Locations

Locations (1)

INC Research; 🇺🇸 Wilmington, North Carolina, United States