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

Status unconfirmed

Conditions studied: Autism, Developmental Delay, Birth Defects

In brief

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.

Key facts

Study ID

NCT01097720

Run by

Massachusetts General Hospital

People needed

298

Starts

2005-03-01

Expected to finish

2010-09-01

Last updated by the study team

2010-04-02

Who can join

Age: 3 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Exposure during the first trimester to other known teratogens.
• Mother with mental health issues
• Refusal to release medical records to confirm eligibility.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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