Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2010-09-30

Brief Summary

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This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include:

1. Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.
2. Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.
3. The child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations.
4. The occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester.

The study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.

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Detailed Description

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Conditions

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Autism Developmental Delay Birth Defects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LTG-exposed

Children exposed to LTG during pregnancy.

No interventions assigned to this group

VPA-exposed

Children exposed to VPA during pregnancy.

No interventions assigned to this group

CBZ-exposed

Children exposed to CBZ during pregnancy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 36-83 months of age
* Prenatal exposure to LTG, VPA, or CBZ monotherapy
* AED was used by mother to suppress seizures
* Mother was enrolled in the North American AED Pregnancy Registry

Exclusion Criteria

* Exposure during the first trimester to other known teratogens.
* Mother with mental health issues
* Refusal to release medical records to confirm eligibility.

Minimum Eligible Age

36 Months

Maximum Eligible Age

83 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes