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

Study Overview
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Brief Summary
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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.

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

Conditions
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Autism, Developmental Delay, Birth Defects

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 83 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LTG-exposed<br>Children exposed to LTG during pregnancy. | |
| VPA-exposed<br>Children exposed to VPA during pregnancy. | |
| CBZ-exposed<br>Children exposed to CBZ during pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adaptive Behavior Scores | 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. | 36-83 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/Absence of Major Malformations | 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. | 36-83 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valproate, Lamotrigine, Carbamazepine, Anticonvulsant, Antiepileptic, Teratogen, Autism, Developmental Delay