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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01097720
First received: March 31, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted

March 31, 2010
March 31, 2010
March 2005
January 2010   (final data collection date for primary outcome measure)
Adaptive Behavior Scores [ Time Frame: 36-83 months of age ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Presence/Absence of Major Malformations [ Time Frame: 36-83 months of age ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine
Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine, Sodium Valproate, or Carbamazepine

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Autism
  • Developmental Delay
  • Birth Defects
Not Provided
  • LTG-exposed
    Children exposed to LTG during pregnancy.
  • VPA-exposed
    Children exposed to VPA during pregnancy.
  • CBZ-exposed
    Children exposed to CBZ during pregnancy.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
298
September 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
36 Months to 83 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01097720
2005P000379
No
Lewis B. Holmes, MD, Massachusetts General Hospital
Massachusetts General Hospital
GlaxoSmithKline
Principal Investigator: Lewis B. Holmes, MD Massachusetts General Hospital
Study Director: Jane Adams, Ph.D. University of Massachusetts, Boston
Massachusetts General Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP