eurodevelopment of babies born to mothers with epilepsy study

Completed

Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine
UKCRC code/ Disease:
Pregnancy and Childbirth

Registration Number: ISRCTN98260309

Lead Sponsor: The University of Manchester

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 385

Inclusion Criteria

1. A diagnosis of epilepsy and either:
1.1. On antiepileptic drug treatment (experimental group)
1.2. Not on treatment (control group)
2. Living within the North West, North East of England or Northern Ireland.
3. Able to provide informed consent
4. In their first or second trimester of pregnancy

Exclusion Criteria

1. Significant learning disability (defined as not able to live independently).
2. Taking non-AED medications which are known to be teratogenic (e.g. warfarin)
3. Unable to understand written or verbal English (due to the standardised assessments in use)

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Sensitivity and specificity of the Ages and Stages Questionnaire for assessing child development (collected at 12 and 24 months of age) <br>2. Behaviour and cognitive skills, assessed using Vineland Adaptive Behaviour Scale-II (collected at 12 and 24 months of age)<br>3. Child development, assessed using Bayley Scales of Infant and Toddler Development-III (collected at 24 months of age)

Secondary Outcome Measures

Name	Time	Method
Child development, assessed using the Bayley Scales of Infant and Toddler Development-III (collected at 24 months of age) across individual antiepileptic drugs treatments.