Antiepileptic drug monitoring In pregnancy

INTERVENTION: 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 (excluding febrile seizures), seizure frequency over the previous 6 months, seizure types, epilepsy syndrome, aetiology of epilepsy, duration of epilepsy, current AED and dose, baseline AED level, learning difficulty, any neurological signs, school leaving age, educational performance, current employment, previous AED pregnancy exposure, previous pregnancy complications, perinatal outcome, number of children, health of child and educational status of child at the first visit. There are 3 groups ‐ The treatment groups will be clinical features monitoring alone versus therapeutic drug monitoring (for some centres around the UK clinical features monitoring is usual practice whereas in other therapeutic drug monitoring is usual practice). The third group will be participants whose blood AED levels remain stable. Women will be followed up in the usual way every 4 weeks. Serum AED levels will be obtained but results will be kept blinded. Details of seizures, responses to QoL questionnaire and obstetric assessments will be recorded 4 weekly. A seizure diary specially developed for collecting trial data will be obtained but results will be kept blinded. It will provide details of type of seizure, frequency of seizure in the last 4 weeks and any side effects from the medication. The daily dose of AED and any increase will be recorded. The foetus will be evaluated by detailed ultrasound scan at 20 weeks for congenital abnormalities and serial growth scans if fetal growth restriction is suspected. Foetal outcomes will be collected antenatal, at delivery and 6 weeks after delivery. An online data entry system, with appropriate security, will allow physicians, and specialist nurses to enter data directly. CONDITION: Epilepsy in pregnancy ; Nervous System Diseases ; Epilepsy PRIMARY OUTCOME: 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. 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 SECONDARY OUTCOME: 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).