Epilepsy Nervous System Diseases Epilepsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. They have a diagnosis of epilepsy and are either: 1.1. Trying to conceive 1.2. They are pregnant and before 21 weeks gestation 1.2.1. They have an expected date of delivery prior to the recruitment closure date (30th November 2019). 2. They are taking either: 2.1. Monotherapy lamotrigine or levetiracetam 2.2. Polytherapy combinations including lamotrigine and levetiracetam and other antiepileptic drugs; with the exception of valproate and carbamazepine. 3. They are receiving their care through one of the participating centres 4. They are willing to complete prospectively recorded seizure diaries
Exclusion criteria
Exclusion criteria: 1. Significant learning disability, requiring support to live independently 2. Experience or history of non-epileptic attacks (also known as NEAD or psychogenic seizures) 3. Taking non-antiepileptic medications which are known to be teratogenic (e.g. warfarin, mycophenolate) 4. English is not the first language in the home
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age. 2. Language development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age. 3. Motor development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Social and behavioural development is measured using Bayley Scales of Infant and Toddler Development at 12- 15 months of age. 2. Maternal experiences of participating in the study is measured using questionnaires when the child is 12- 15 months of age. | — |
Countries
United Kingdom