Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine
Recruitment status was: Active, not recruiting
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:
- Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.
- Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.
- 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.
- 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine|
- Adaptive Behavior Scores [ Time Frame: 36-83 months of age ] [ Designated as safety issue: No ]Measures of each child's Adaptive Behavior scores as assessed by the Vineland-II Adaptive Behavior Scales, collected when the child was between 36 and 83 months of age.
- Presence/Absence of Major Malformations [ Time Frame: 36-83 months of age ] [ Designated as safety issue: No ]Based on interview with mother and review of medical records, determination is made as to whether or not the child had any major malformations at birth.
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||September 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Children exposed to LTG during pregnancy.
Children exposed to VPA during pregnancy.
Children exposed to CBZ during pregnancy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097720
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Lewis B. Holmes, MD||Massachusetts General Hospital|
|Study Director:||Jane Adams, Ph.D.||University of Massachusetts, Boston|