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?
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.
Study Type
OBSERVATIONAL
Enrollment
331
IQ measurement at 3, 4.5 and 6 years of age
Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
University of Alabama
Birmingham, Alabama, United States
Arizona Health Sciences
Child IQ as measured by the Differential Abilities Scale at 6 Years of age
Time frame: 6 years
Executive Functioning,Tower-NEPSY
Time frame: 6 Years
Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales
Time frame: 6 Years
Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale
Time frame: 6 Years
Memory via Children's Memory Scale
Time frame: 6 Years
Motor Functioning via Grooved Pegboard
Time frame: 6 Years
Academic Functioning via Wide Range Achievement Test
Time frame: 6 Years
Adaptive Functioning via Adaptive Behavior System -2nd Edition
Time frame: 6 Years
Behavior via Behavior Assessment for Children & Parent Stress Index
Time frame: 6 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Georgetown University
Washington D.C., 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
...and 11 more locations