EpiSafe

• Research type

  Research Study

• Full 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.

• IRAS ID

  353310

• Contact name

  Shakila Thangaratinam

• Contact email

  s.thangaratinam@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  Background
  Epilepsy is a condition that affects the brain and causes seizures. Seizures are strong bursts of electrical activity in the brain that can lead to loss of consciousness, shaking and confusion. They increase the risk of falls and injuries and can affect people’s independence, ability to work, and care for others.

  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 risk of seizures and is why specialist epilepsy care is recommended during pregnancy. However, in practice many don’t receive specialist care or early enough.

  What will the study do?
  In the ‘EpiSafe’ study, midwives 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.

  Where and how will the study run?
  The study will run in around 34 NHS maternity units over two years. Half of the units will use the ‘EpiSafe bundle’, and half will continue with usual care. We will compare whether the bundle improves access to specialist epilepsy care in the first 14 weeks of pregnancy for women identified to be at increased risk. We will also look at outcomes for women and their babies, and how well the bundle works in practice. Interviews with pregnant women and healthcare professionals will help with this plan.
  

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  25/WM/0109

• Date of REC Opinion

  3 Jul 2025

• REC opinion

  Further Information Favourable Opinion