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

• Conditions: Autism; Developmental Delay; Birth Defects

• Registration Number: NCT01097720
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2010-01
• Status Verified: 2010-03
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Last Update Submitted: 2010-03-31
• Study First Posted: 2010-04-02
• Last Update Posted: 2010-04-02
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 298

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adaptive Behavior Scores	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.

Secondary Outcome Measures

Name	Time	Method
Presence/Absence of Major Malformations	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States