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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study

Conditions
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Epilepsy, Seizure, Cognition Disorders

Intervention / Treatment
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* Behavioral: Differential Abilities Scale
* Behavioral: Neuropsychological Testing


Participation Criteria
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Eligibility Criteria
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Subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures) Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy. Mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse. Mothers must be able to maintain an accurate seizure diary of major motor seizures Subjects must have an IQ greater than or equal to 70 points. Subjects must have a history of a negative RPR and HIV. Subjects must not have progressive cerebral disease or presence of other major medical illness Subjects must not have exposure to known teratogens during pregnancy, except AEDs. Subjects must not have poor compliance with prenatal care. Subjects must have adequate reading skills to perform the cognitive tests.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carbamazepine<br>Children and their mothers exposed to Carbamazepine monotherapy in utero | Behavioral: Differential Abilities Scale<br>* IQ measurement at 3, 4.5 and 6 years of age<br>* Other names: DAS;Behavioral: Neuropsychological Testing<br>* Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age<br>* Other names: Parenting Stress Index;|
| Phenytoin<br>Children and their mothers exposed to phenytoin in utero | Behavioral: Differential Abilities Scale<br>* IQ measurement at 3, 4.5 and 6 years of age<br>* Other names: DAS;Behavioral: Neuropsychological Testing<br>* Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age<br>* Other names: Parenting Stress Index;|
| Lamotrigine<br>Children and their mothers exposed to Lamotrigine in utero | Behavioral: Differential Abilities Scale<br>* IQ measurement at 3, 4.5 and 6 years of age<br>* Other names: DAS;Behavioral: Neuropsychological Testing<br>* Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age<br>* Other names: Parenting Stress Index;|
| Valproate<br>Children and their mothers exposed to Valproate in utero | Behavioral: Differential Abilities Scale<br>* IQ measurement at 3, 4.5 and 6 years of age<br>* Other names: DAS;Behavioral: Neuropsychological Testing<br>* Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age<br>* Other names: Parenting Stress Index;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child IQ as measured by the Differential Abilities Scale at 6 Years of age |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive Functioning,Tower-NEPSY |  | 6 Years | 
| Linguistic Functioning via Expressive one word vocabulary test and NEPSY subscales |  | 6 Years | 
| Visual-Spatial Motor Functioning via NEPSY subscale and Visual-Motor Integration Scale |  | 6 Years | 
| Memory via Children's Memory Scale |  | 6 Years | 
| Motor Functioning via Grooved Pegboard |  | 6 Years | 
| Academic Functioning via Wide Range Achievement Test |  | 6 Years | 
| Adaptive Functioning via Adaptive Behavior System -2nd Edition |  | 6 Years | 
| Behavior via Behavior Assessment for Children & Parent Stress Index |  | 6 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AED, seizure, epilepsy, pregnancy, antiepileptic, carbamazepine, phenytoin, valproate, lamotrigine, child, behavior