Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy

Completed

• Conditions: Epilepsy; Cognition Disorders; Seizure
• Interventions: Behavioral: Differential Abilities Scale; Behavioral: Neuropsychological Testing

• 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.

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2001-08-08
• Study First Submitted QC: 2001-08-09
• Study First Posted: 2001-08-10
• Primary Completion: 2010-08
• Study Completion: 2012-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 331

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phenytoin	Neuropsychological Testing	Children and their mothers exposed to phenytoin in utero
Phenytoin	Differential Abilities Scale	Children and their mothers exposed to phenytoin in utero
Valproate	Differential Abilities Scale	Children and their mothers exposed to Valproate in utero
Carbamazepine	Differential Abilities Scale	Children and their mothers exposed to Carbamazepine monotherapy in utero
Carbamazepine	Neuropsychological Testing	Children and their mothers exposed to Carbamazepine monotherapy in utero
Lamotrigine	Differential Abilities Scale	Children and their mothers exposed to Lamotrigine in utero
Lamotrigine	Neuropsychological Testing	Children and their mothers exposed to Lamotrigine in utero
Valproate	Neuropsychological Testing	Children and their mothers exposed to Valproate in utero

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
Memory via Children's Memory Scale	6 Years
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
Adaptive Functioning via Adaptive Behavior System -2nd Edition	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

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

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