Epilepsy in pregnancy Nervous System Diseases Epilepsy
Conditions
Interventions
Relevant neurological and obstetric history will be obtained from pregnant women with epilepsy at booking / antenatal visit. Baseline data will be collected on age, ethnicity, age at first seizure (ex
Sponsors
Queen Mary, University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Have signed a consent form before undergoing any trial-related activities 2. Have a confirmed viable pregnancy of less than 16 weeks gestation at booking 3. Have a confirmed diagnosis of epilepsy (any syndrome: primary, localised or unclassified) 4. Currently prescribed lamotrigine monotherapy or polytherapy (with carbamazepine, phenytoin or levetiracetam), carbamazepine monotherapy, phenytoin monotherapy or levetiracetam monotherapy 5. Be capable of understanding the information provided, with use of an interpreter if required
Exclusion criteria
Exclusion criteria: 1. Be beyond 16 weeks gestation at booking 2. Documented non-epileptic seizures in the last 2 years 3. Documented of status epilepticus in the last 12 months 4. A history of alcohol or substance abuse or dependence in the last 2 years 5. Sodium valproate (VPA) monotherapy or polytherapy 6. Non lamotrigine polytherapy 7. A history of poor AED adherence 8. Unable to complete a seizure diary or recall frequency of seizures accurately 9. Have a significant learning disability 10. Participation in any blinded, placebo-controlled trials of investigational medicinal products in pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomisation to first seizure and time to first tonic clonic seizure throughout pregnancy up to and including six weeks post-delivery. Statistical analysis will take into account the time to each ?event? per woman over the whole period of monitoring. Participants will be asked to document the occurrence of each seizure by frequency and type in a trial specific seizure diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal: 1.Neurological 1.1. Percentage of women experiencing seizures who were seizure free in three month prior to consent. Number of seizures per week and number of seizure free days per week throughout pregnancy and up to and including six weeks post delivery 1.2. Serum levels of AED in each trimester, daily dose exposure by trimester, cumulative dose exposure for pregnancy, adverse events as measured by the Liverpool Adverse Events Profile 2. Obstetric Maternal death, mode of delivery, preterm labour, induction of labour, pre eclampsia, antepartum and postpartum haemorrhage, admission to high dependency/ intensive care unit, breast feeding, infection, gestational diabetes mellitus 3. Quality of Life: Epilepsy specific QoL as measured by QOLIE-31, generic QoL as measured by EQ-5D Foetal and neonatal: Major and minor congenital malformation: major congenital malformations defined as structural abnormalities with surgical, medical or cosmetic importance at antenatal or post natal diagnosis. Apgar score at 1? and 5? minutes, admission to neonatal unit, birth weight, head circumference, foetal growth, stillbirths, neonatal deaths, Bayley Scales of Infant Development (BSID). | — |
Countries
United Kingdom
Outcome results
None listed