Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
- Conditions
- EpilepsyCognition DisordersSeizure
- Registration Number
- NCT00021866
- Lead Sponsor
- Emory University
- Brief Summary
The purpose of this study is to determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?
- Detailed Description
This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 331
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Child IQ as measured by the Differential Abilities Scale at 6 Years of age 6 years
- Secondary Outcome Measures
Name Time Method Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale 6 Years Behavior via Behavior Assessment for Children & Parent Stress Index 6 Years Academic Functioning via Wide Range Achievement Test 6 Years Executive Functioning,Tower-NEPSY 6 Years Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales 6 Years Motor Functioning via Grooved Pegboard 6 Years Adaptive Functioning via Adaptive Behavior System -2nd Edition 6 Years Memory via Children's Memory Scale 6 Years
Trial Locations
- Locations (21)
University of Alabama
🇺🇸Birmingham, Alabama, United States
Arizona Health Sciences
🇺🇸Tucson, Arizona, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
RUSH University Medical Center
🇺🇸Chicago, Illinois, United States
Via Christi Medical Center
🇺🇸Wichita, Kansas, United States
Brigham & Womens' Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Scroll for more (11 remaining)University of Alabama🇺🇸Birmingham, Alabama, United States