Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine
|ClinicalTrials.gov Identifier: NCT01097720|
Recruitment Status : Unknown
Verified March 2010 by Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 2, 2010
Last Update Posted : April 2, 2010
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.
|Condition or disease|
|Autism Developmental Delay Birth Defects|
|Study Type :||Observational|
|Actual Enrollment :||298 participants|
|Official Title:||Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||September 2010|
Children exposed to LTG during pregnancy.
Children exposed to VPA during pregnancy.
Children exposed to CBZ during pregnancy.
- Adaptive Behavior Scores [ Time Frame: 36-83 months of age ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|