NCT01097720

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 298 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 36 Months – 83 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Autism
• Developmental Delay
• Birth Defects

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-01-01
• Completion: 2010-09-01
• First posted: 2010-04-02
• Last updated: 2010-04-02

Locations

1 site across 1 country: United States