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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

Page last updated: August 23, 2015

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