Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autism; Developmental Delay; Birth Defects
Phase: N/A
Status: Active, not recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): Lewis B. Holmes, MD, Principal Investigator, Affiliation: Massachusetts General Hospital Jane Adams, Ph.D., Study Director, Affiliation: University of Massachusetts, Boston
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.
Clinical Details
Official title: Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Adaptive Behavior Scores
Secondary outcome: Presence/Absence of Major Malformations
Eligibility
Minimum age: 36 Months.
Maximum age: 83 Months.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: March 2005
Last updated: March 31, 2010
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