Pregnant women with epilepsy Pregnancy and Childbirth
Conditions
Interventions
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 accordi
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of high-risk pregnant women with epilepsy accessing specialist epilepsy care in first 14 weeks of gestation, calculated as a percentage of all those considered to be at high risk ; Timepoint(s): At 14 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 23/02/2026: 1. The occurrence of any type of seizure, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 2. Increase in the frequency or severity of seizures, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 3. Prolonged epileptic seizures lasting 30 minutes or a series of seizures with incomplete return of consciousness (status epilepticus), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 4. Death of pregnant women, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy or within 42 days of termination of pregnancy 5. Occurrence of epileptic seizures that result in altered consciousness, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 6. Accidents or injuries directly resulting from seizure activities, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 7. Any hospital admissions resulting from seizure activity during pregnancy, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 8. Admission to high dependency or intensive care unit for any reason, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 9. Anti-seizure medication adherence during pregnancy, obtained from care provider log; Timepoint(s): During pregnancy 10. Development of new-onset hypertension and proteinuria after 20 weeks of gestation (pre-eclampsia), obtained directly from patient records and clinical notes; Timepoint(s): After 20 weeks of gestation 11. Onset of labour before 37 weeks of gestation, obtained directly from patient records and clinical notes; Timepoint(s): At 37 weeks of pregnancy 12. Rupture of membranes before the onset of labour, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 13. Pr | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactCarmel Moore
Outcome results
None listed