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

Mass General Brigham

Status: Unknown

Conditions: Birth Defects; Developmental Delay; Autism

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01097720

2005P000379

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: All

Ages: 36 to 83 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

298 participants in 3 patient groups

LTG-exposed

Description:

Children exposed to LTG during pregnancy.

VPA-exposed

Description:

Children exposed to VPA during pregnancy.

CBZ-exposed

Description:

Children exposed to CBZ during pregnancy.