Clinical trial NCT00345475: UCB Antiepileptic Drugs (AED) Pregnancy Registry (Formerly the Keppra® Pregnancy Registry)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Defects
Pregnancy Complications
Epilepsy
Seizures
Keywords: Birth Defects
Epilepsy
High Risk Pregnancy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-06-28
Enrollment: 516
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See Inclusion Criteria

- Women who have been diagnosed with Epilepsy and continued their UCB AED medication while pregnant

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).


Eligibility criteria: 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)

Primary outcomes:
measure: The number of birth defects reported and confirmed by a teratologist
timeFrame: Throughout pregnancy and up to 3 years of life
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: INC Research
state: North Carolina
Study officials:
affiliation: Syneos Health
name: Vikki Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCB Pharma
name: Jürgen Bentz, PhD
role: STUDY_DIRECTOR
References:
citation: Scheuerle AE, Holmes LB, Albano JD, Badalamenti V, Battino D, Covington D, Harden C, Miller D, Montouris GD, Pantaleoni C, Thorp J, Tofighy A, Tomson T, Golembesky AK. Levetiracetam Pregnancy Registry: Final results and a review of the impact of registry methodology and definitions on the prevalence of major congenital malformations. Birth Defects Res. 2019 Aug 1;111(13):872-887. doi: 10.1002/bdr2.1526. Epub 2019 May 23.