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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01097720
Recruitment Status : Unknown
Verified March 2010 by Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 2, 2010
Last Update Posted : April 2, 2010
Information provided by:
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.

Condition or disease
Autism Developmental Delay Birth Defects

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Study Type : Observational
Actual Enrollment : 298 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine
Study Start Date : March 2005
Actual Primary Completion Date : January 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Children exposed to LTG during pregnancy.
Children exposed to VPA during pregnancy.
Children exposed to CBZ during pregnancy.

Primary Outcome Measures :
  1. Adaptive Behavior Scores [ Time Frame: 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 :
  1. Presence/Absence of Major Malformations [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children 36-83 months of age, prenatally exposed to LTG, VPA, or CBZ monotherapies, recruited through mothers enrolled in the North American Antiepileptic Drug Pregnancy Registry.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01097720

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Lewis B. Holmes, MD Massachusetts General Hospital
Study Director: Jane Adams, Ph.D. University of Massachusetts, Boston
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Responsible Party: Lewis B. Holmes, MD, Massachusetts General Hospital Identifier: NCT01097720    
Other Study ID Numbers: 2005P000379
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: April 2, 2010
Last Verified: March 2010
Keywords provided by Massachusetts General Hospital:
Developmental Delay
Additional relevant MeSH terms:
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Congenital Abnormalities