Autism Clinical Trial
Official title:
Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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