This trial is active, not recruiting.

Conditions autism, developmental delay, birth defects
Sponsor Massachusetts General Hospital
Collaborator GlaxoSmithKline
Start date March 2005
End date January 2010
Trial size 298 participants
Trial identifier NCT01097720, 2005P000379


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Children exposed to LTG during pregnancy.
Children exposed to VPA during pregnancy.
Children exposed to CBZ during pregnancy.

Primary Outcomes

Adaptive Behavior Scores
time frame: 36-83 months of age

Secondary Outcomes

Presence/Absence of Major Malformations
time frame: 36-83 months of age

Eligibility Criteria

Male or female participants from 36 months up to 83 months old.

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.

Additional Information

Official title Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine
Principal investigator Lewis B. Holmes, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.