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

NCT01097720 | Unknown

• 1 other identifier: 2005P000379
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

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. 1.Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism.
2. 2.Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations.
3. 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. 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.

Conditions

Autism; Developmental Delay; Birth Defects

Keywords

Valproate; Lamotrigine; Carbamazepine; Anticonvulsant; Antiepileptic; Teratogen; Autism; Developmental Delay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Presence/Absence of Major Malformations

  36-83 months of age

Study Arms (3)

LTG-exposed

Children exposed to LTG during pregnancy.

VPA-exposed

Children exposed to VPA during pregnancy.

CBZ-exposed

Children exposed to CBZ during pregnancy.

Eligibility Criteria

• Age: 36 Months - 83 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Exposure during the first trimester to other known teratogens.
• Mother with mental health issues
• Refusal to release medical records to confirm eligibility.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Learning Disabilities; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lewis B. Holmes, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jane Adams, Ph.D.

  University of Massachusetts, Boston

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 2, 2010
• Study Start: March 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 2, 2010

Record last verified: 2010-03

Locations

US (1)