Evaluating the impact of the EpiSafe bundle on care and clinical outcomes for pregnant women with epilepsy and their babies: a cluster randomised hybrid implementation-effectiveness trial, process evaluation and qualitative study with economic evaluation
Pregnant women with epilepsy
Maternity units will be randomised to either an intervention or control arm in a 1:1 ratio. All women receiving antenatal care in a specific maternity unit (cluster) will receive the same care according to the allocation of the cluster. Intervention arm: EpiSafe bundle The EpiSafe bundle incorporates a structured risk assessment and implementation strategies to facilitate identification and referral of high-risk pregnant women with epilepsy for early specialist epilepsy care. Booking midwives will use the EpiSafe bundle during the antenatal booking visit (first antenatal appointment) of pregnant women with epilepsy. Control arm: Usual care Pregnant women will be booked for their usual care according to existing National Institute for Health and Care Excellence (NICE) and Royal College of Obstetricians and Gynaecologists guidelines. In both arms, women will be followed up until the end of pregnancy.
Unit-level inclusion criteria: NHS maternity units providing antenatal care for pregnant women with epilepsy, with a pathway to access specialist antenatal epilepsy care Individual level inclusion criteria: All pregnant women >=18 years of age with a confirmed diagnosis of epilepsy, attending antenatal booking visit at participating maternity units in their first trimester
Current key exclusion criteria as of 23/02/2026: Unit-level exclusion criteria, maternity units: 1. Where there is no access to dedicated epilepsy specialists (either obstetric or neurological) 2. That lack the resources to implement the EpiSafe bundle 3. Where procedures are already in place for all women with epilepsy to access specialist epilepsy care <14 weeks' gestation Individual level exclusion criteria, pregnant women: 1. With non-epileptic attack disorder (NEAD) 2. Whose epilepsy diagnosis was not confirmed before pregnancy 3. Less than 18 years of age 4. Withdrawal of consent to use data, through the NHS data opt-out _____ Previous key exclusion criteria: Unit-level exclusion criteria, maternity units: 1. Where there is no access to dedicated epilepsy specialists (either obstetric or neurological) 2. That lack the resources to implement the EpiSafe bundle 3. Where procedures are already in place for all women with epilepsy to access specialist epilepsy care <14 weeks' gestation Individual level exclusion criteria, pregnant women: 1. With non-epileptic attack disorder (NEAD) 2. Whose epilepsy diagnosis was not confirmed before pregnancy 3. Who had already seen or are planning to see an epilepsy specialist in the first trimester 4. Less than 18 years of age 5. Withdrawal of consent to use data, through the NHS data opt-out