Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
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ClinicalTrials.gov Identifier: NCT00021866 |
Recruitment Status :
Completed
First Posted : August 10, 2001
Last Update Posted : November 11, 2013
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Condition or disease | Intervention/treatment |
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Epilepsy Seizure Cognition Disorders | Behavioral: Differential Abilities Scale Behavioral: Neuropsychological Testing |
Study Type : | Observational |
Actual Enrollment : | 331 participants |
Observational Model: | Family-Based |
Time Perspective: | Prospective |
Official Title: | Neurodevelopmental Effects of Antiepileptic Drugs II: the NEAD Study |
Study Start Date : | September 2000 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2012 |

Group/Cohort | Intervention/treatment |
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Carbamazepine
Children and their mothers exposed to Carbamazepine monotherapy in utero
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Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS Behavioral: Neuropsychological Testing Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
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Phenytoin
Children and their mothers exposed to phenytoin in utero
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Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS Behavioral: Neuropsychological Testing Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
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Lamotrigine
Children and their mothers exposed to Lamotrigine in utero
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Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS Behavioral: Neuropsychological Testing Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
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Valproate
Children and their mothers exposed to Valproate in utero
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Behavioral: Differential Abilities Scale
IQ measurement at 3, 4.5 and 6 years of age
Other Name: DAS Behavioral: Neuropsychological Testing Tests of memory, attention, and behavior administered at 2,3, 4.5 and 6 Years of age
Other Names:
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- 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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021866

Principal Investigator: | Kimford J. Meador, M.D. | Emory University, Atlanta |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kimford J. Meador, MD, Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT00021866 |
Other Study ID Numbers: |
0334-2001 2R01NS038455 ( U.S. NIH Grant/Contract ) 2R01NS038455-06 ( U.S. NIH Grant/Contract ) |
First Posted: | August 10, 2001 Key Record Dates |
Last Update Posted: | November 11, 2013 |
Last Verified: | September 2013 |
epilepsy seizure pregnancy antiepileptic AED carbamazepine |
phenytoin valproate lamotrigine child behavior |
Epilepsy Seizures Cognition Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Neurocognitive Disorders Mental Disorders |