Improving epilepsy and pregnancy care
| ISRCTN | ISRCTN63771613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63771613 |
| IRAS number | 353310 |
| Secondary identifying numbers | CPMS 68695; Grant Code: NIHR204156 |
- Submission date
- 24/06/2025
- Registration date
- 27/06/2025
- Last edited
- 17/07/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Every year in the UK, around 2,500 women with epilepsy get pregnant. Epilepsy is one of the leading causes of maternal death and women with epilepsy face higher risks during pregnancy such as miscarriage, high blood pressure, early birth, and problems with the baby’s growth. During pregnancy, changes in the body can affect seizure patterns and how medicines which help control epilepsy are processed in the body. Some women stop taking their medication on their own because they worry it may harm their baby. These factors can increase the risk of seizures which is why specialist epilepsy care is recommended during pregnancy. However, in practice, many don’t receive specialist care or early enough. For this study, a new programme (the EpiSafe bundle) has been developed, which aims to support more women accessing specialist care during pregnancy and to improve overall health outcomes.
Who can participate?
The study will take place at NHS Maternity Units across the UK. The study design (cluster randomised controlled trial) means that all pregnant women aged 18 years and over with epilepsy who attend the antenatal clinics at participating maternity units will automatically be part of the study if they meet the study inclusion criteria. While pregnant women with epilepsy will not be approached to consent to take part in the study, they will be made aware of its existence and the use of their data through a study poster and dedicated website. Women will have the option to opt out of data collection via the national NHS digital data opt-out system.
What does the study involve?
Midwives in the maternity units randomly allocated to the ‘EpiSafe bundle’ will apply the ‘EpiSafe bundle’ at the first antenatal appointment. It includes a short risk assessment to identify pregnant women with epilepsy at increased risk and refer them early to an epilepsy specialist. If a maternity unit is allocated to EpiSafe, all eligible women with epilepsy attending that unit will automatically receive the EpiSafe intervention as part of their standard care during their antenatal booking visit. In the units allocated to usual care (the control group), women will be booked according to the standard guidelines according to the National Institute for Health and Care Excellence (NICE) and the Royal College of Obstetricians and Gynaecologists guidelines. The study will also involve interviews with two different groups: 25 – 30 healthcare professionals and 18 – 24 women with epilepsy at maternity sites allocated to the EpiSafe bundle. These interviews will explore what poses barriers to and what helps health professionals use the EpiSafe bundle and pregnant women’s experiences of being exposed to it.
What are the possible benefits and risks of participating?
The EpiSafe bundle has the potential to increase access to specialist epilepsy care in the first 14 weeks for women at high risk due to their epilepsy. The study primarily uses data collected as part of routine care and therefore minimises disruption to the lifestyle and care of women with epilepsy. There are no anticipated risks to pregnant women with epilepsy cared for in the maternity units in the intervention arm. This is because their care and their care pathways remain the same. The intervention will only aid in the systematic assessment of the high-risk women and early referral to specialist epilepsy teams.
Where is the study run from?
The project is being sponsored by the University of Liverpool and is being conducted in collaboration with Anglia Ruskin University and Birmingham City University (UK)
When is the study starting and how long is it expected to run for?
April 2015 to June 2027
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
John Allotey, john.allotey@liverpool.ac.uk
Contact information
Public
Anglia Ruskin University
Faculty of Health, Education, Medicine, and Social Care
Bishops Hall Lane
Chelmsford
CM1 1SQ
United Kingdom
 ORCID ID |
0000-0002-2386-7200 |
|---|---|
| Phone | +44 (0)1245 684938 |
| carmel.moore@aru.ac.uk |
Scientific
University of Liverpool
Department of Epidemiology and Women’s Health
William Henry Duncan Building
6 West Derby Street
Liverpool
L7 8TX
United Kingdom
| ORCID ID |
0000-0003-4134-6246 |
|---|---|
| john.allotey@liverpool.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Screening, Prevention, Process of Care, Management of Care, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | EpiSafe |
| Study objectives | The implementation of the EpiSafe bundle at antenatal booking will increase the proportion of high-risk pregnant women with epilepsy accessing specialist epilepsy care before 14 weeks’ gestation and improve maternal and perinatal outcomes. |
| Ethics approval(s) | Approved 03/07/2025, West Midlands - Black Country Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 104 8010; blackcountry.rec@hra.nhs.uk), ref: 25/WM/0109 |
| Health condition(s) or problem(s) studied | Pregnant women with epilepsy |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 1. The occurrence of any type of seizure, obtained directly from patient records and clinical notes (key secondary outcome); 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. Method of delivery (vaginal or caesarean), obtained directly from patient records and clinical notes; Timepoint(s): At time of delivery of baby 12. Onset of labour before 37 weeks of gestation, obtained directly from patient records and clinical notes; Timepoint(s): At 37 weeks of pregnancy 13. Rupture of membranes before the onset of labour, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 14. Premature separation of the placenta from the uterine wall (placental abruption), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 15. Blood loss of 500 ml or more from the genital tract within 24 hours of birth (peripartum haemorrhage), obtained directly from patient records and clinical notes; Timepoint(s): Within 24 hours of birth 16. Spontaneous loss of pregnancy before 24 weeks of gestation (miscarriage), obtained directly from patient records and clinical notes; Timepoint(s): At 24 weeks of gestation 17. Implantation of fertilised egg outside the uterus (ectopic pregnancy), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 18. Intentional ending of pregnancy (termination of pregnancy), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy 19. Initiation of breastfeeding within the first 48 hours postpartum, obtained directly from patient records and clinical notes; Timepoint(s): At 48 hours postpartum 20. Fetal death occurring at or after 24 weeks gestation (stillbirth), obtained directly from patient records and clinical notes; Timepoint(s): End of pregnancy 21. Death of a live-born infant within the first 28 days of life (neonatal death), obtained directly from patient records and clinical notes; Timepoint(s): Within the first 28 days of the infant's life 22. Presence of major structural or genetic abnormalities (congenital abnormalities), obtained directly from patient records and clinical notes; Timepoint(s): At birth 23. Birth occurring before 37 completed weeks of gestation (pre-term birth), obtained directly from patient records and clinical notes; Timepoint(s): At 37 weeks of gestation 24. Weight below the 10th percentile for gestational age at birth, obtained directly from patient records and clinical notes; Timepoint(s): At birth 25. APGAR score <7 at 1 and 5 minutes after birth, obtained directly from patient records and clinical notes; Timepoint(s): At 1 and 5 minutes after birth 26. Neonatal intensive care unit admission for any reason, obtained directly from patient records and clinical notes; Timepoint(s): At birth 27. Blood glucose level 5 mg/dL (2.5 mmol/L) in the first 24 hours of life (hypoglycaemia) obtained directly from patient records and clinical notes; Timepoint(s): In the first 24 hours of the infant’s life 28. Need for neonatal resuscitation measures at birth, obtained directly from patient records and clinical notes; Timepoint(s): At birth 29. Brain injury due to oxygen deprivation around the time of birth (hypoxic-ischemic encephalopathy), obtained directly from patient records and clinical notes; Timepoint(s): At birth 30 Percentage of all women with epilepsy in the intervention arm who receive EpiSafe intervention (REACH), obtained from medical records; Timepoint(s): End of intervention delivery 31. Percentage of booking midwives who complete the EpiSafe training (ADOPTION), obtained from training logs; Timepoint(s): End of intervention delivery 32. Percentage of the components of the EpiSafe bundle delivered according to the protocol (FIDELITY), obtained from medical records; Timepoint(s): Over the duration of a maternity unit's involvement in the study 33. Number of components of the EpiSafe bundle adapted (ADAPTION), obtained from medical notes; Timepoint(s): Over the duration of a maternity unit's involvement in the study 34. Percentage of EpiSafe intervention components delivered (DOSE); Timepoint(s): Over the duration of a maternity unit's involvement in the study 35. Patient and healthcare professional rating of EpiSafe bundle’s suitability for individual sites (APPROPRIATENESS); Timepoint(s): End of intervention delivery 36. Written protocol for management of (i) status epilepticus, (ii) epilepsy in pregnancy obtained from hospital documents; Timepoint(s): End of intervention delivery 37. Percentage of healthcare professionals caring for pregnant women with epilepsy trained in EpiSafe bundle, obtained from training log; Timepoint(s): End of intervention delivery 38. Number of multi-disciplinary team meetings discussing the high-risk women management, obtained from medical records; Timepoint(s): End of pregnancy 39. Implementation of regular audit and feedback cycles for care of epilepsy in pregnancy, obtained from quality improvement report; Timepoint(s): End of intervention delivery 40. Acceptability of the EpiSafe bundle to women, families, healthcare professionals measured via interviews; Timepoint(s): End of intervention delivery Assessment of the EpiSafe bundle’s adaptability, feasibility and impact on health equity measured via interviews; Timepoint(s): End of intervention delivery 41. Identification of implementation barriers to intervention delivery and study conduct measured via interviews; Timepoint(s): End of intervention delivery 42. Patient reported experience measures (PREMs) on process of care: dignity, information, trust, positive birth experience measured via interviews; Timepoint(s): End of intervention delivery 43. Total cost associated with implementing the EpiSafe bundle measured via an economic evaluation; Timepoint(s): During pregnancy 44. Percentage of pregnant women with epilepsy who undergo a formal assessment of seizure risk and current anti-seizure medication during pregnancy, obtained from medical records; Timepoint(s): During pregnancy 45. Percentage of high-risk pregnant women on anti-seizure medication accessing specialist care within 2 weeks from referral, obtained from medical records; Timepoint(s): During pregnancy 46. Proportion of all women with epilepsy in whom discussion on risk-benefit of seizures and anti-seizure medications recorded during pregnancy, obtained from medical records; Timepoint(s): During pregnancy 47. Percentage of all pregnant women with epilepsy on anti-seizure medication who had a medication review in their first visit with the epilepsy specialist, obtained from medical records; Timepoint(s): At the first visit with an epilepsy specialist 48. Percentage of pregnant women with epilepsy who receive information on epilepsy in pregnancy; Timepoint(s): During pregnancy |
| Overall study start date | 01/04/2015 |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 1836; UK Sample Size: 1836 |
| Key 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 |
| 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 |
| Date of first enrolment | 01/09/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Leighton
Crewe
CW1 4QJ
United Kingdom
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Queen Elizabeth Hospital Site
King's Lynn
PE30 4ET
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Cumberland Infirmary
Infirmary Street
Carlisle
CA2 7HY
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Guildford
GU2 7XX
United Kingdom
Grove Lane
Smethwick
B66 2QT
United Kingdom
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom
Crown Street
Liverpool
L8 7SS
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Ayr
KA6 6AB
United Kingdom
Birmingham
B4 6NH
United Kingdom
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Lovely Lane
Warrington
WA5 1QG
United Kingdom
Moat Road
Walsall
WS2 9PS
United Kingdom
Chertsey
KT16 0PZ
United Kingdom
Leighton
Crewe
CW1 4QJ
United Kingdom
729 the Ridge
St. Leonards-on-sea
TN37 7PT
United Kingdom
Frimley
Camberley
GU16 7UJ
United Kingdom
London
SE1 7EH
United Kingdom
London
SE5 9RS
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Sponsor information
University/education
Clinical Directorate, 4th Floor, Thompson Yates Building
Faculty of Health and Life Sciences
Liverpool
L69 3GB
England
United Kingdom
| Phone | +44 (0)151 795 1780 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study will be published in peer-reviewed scientific journals, presented at national and international conferences and published on the EpiSafe website (https://www/episafe.org). The study results will be made available to participants through a variety of channels, including the study’s dedicated website (https://www/episafe.org), participating NHS Trust websites and social media announcements directing participants to the main study website. The result dissemination will be after the data analysis is complete and has been peer reviewed (anticipated date 31/05/2028). |
| IPD sharing plan | Anonymised data generated during the trial may be shared with a qualified third party upon request. Data requests will be considered by the CI (Prof Shakila Thangaratinam; s.thangaratinam@liverpool.ac.uk) and the sponsor (sponsor@liverpool.ac.uk). For approved requests, the dataset will be prepared by the coordinating centre and will be provided as a summary at a cluster and study level only. A data-sharing agreement will be required between the sponsor and the external party. |
Editorial Notes
17/07/2025: Ethics approval details added. The date of first enrolment was changed from 01/07/2025 to 01/09/2025.
24/06/2025: Study's existence confirmed by the NIHR.
