Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine
Conditions
Interventions
Surveillance for neurodevelopmental teratogenic effects of pharmacological treatment during pregnancy is limited, the consequence of which is that treatment is unlikely to be optimised for maternal or
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity and specificity of the Ages and Stages Questionnaire for assessing child development (collected at 12 and 24 months of age) 2. Behaviour and cognitive skills, assessed using Vineland Adaptive Behaviour Scale-II (collected at 12 and 24 months of age) 3. Child development, assessed using Bayley Scales of Infant and Toddler Development-III (collected at 24 months of age) | — |
Secondary
| Measure | Time frame |
|---|---|
| Child development, assessed using the Bayley Scales of Infant and Toddler Development-III (collected at 24 months of age) across individual antiepileptic drugs treatments. | — |
Countries
United Kingdom
Contacts
Public ContactRebecca Bromley
Outcome results
None listed