RecruitingInterventional

Improving epilepsy and pregnancy care

This study focuses on improving care for pregnant women with epilepsy, a group who face higher risks during pregnancy. About 2,500 women in the UK with epilepsy get pregnant each year, and they often don't get specialist care early enough. This new study introduces the 'EpiSafe bundle,' a programme designed to help maternity units identify and refer women with epilepsy to specialists sooner. The study involves randomly assigning maternity units to either use this new 'EpiSafe bundle' or continue with standard care. Researchers will then compare outcomes to see if EpiSafe leads to better health for mothers and babies. Women attending participating units will automatically be part of the study's data collection, with an option to opt out.

At a glance

Status

Recruiting

Sponsor

University of Liverpool

Enrolment target

1,866

Start

11 Sep 2025

Estimated completion

30 Jun 2027

Pregnant women with epilepsy

What is this study about?

Each year in the UK, many women with epilepsy become pregnant. While this is a special time, it can also bring unique challenges for women with epilepsy. They might face higher risks during pregnancy, such as complications like high blood pressure or issues with the baby's growth. Changes in the body during pregnancy can also affect how epilepsy medicines work and even change seizure patterns. Sometimes, women worry about their medication harming their baby and might stop taking it, which can be risky for them.

Because of these concerns, it's really important for pregnant women with epilepsy to receive specialist care. However, this doesn't always happen, or it might not happen early enough. This study introduces something called the 'EpiSafe bundle,' which is a new programme designed to help more pregnant women with epilepsy get the special care they need sooner. The main goal is to improve the health and safety of both mothers and their babies.

To see if the EpiSafe bundle works, different maternity units across the UK will be chosen at random. Some will use the EpiSafe bundle, while others will continue with their usual care. Researchers will then look at health information to see if the units using EpiSafe have better results for their patients. They will also talk to healthcare staff and some women to understand how the new programme works in practice and what it feels like for patients.

Key takeaways

Targets pregnant women with epilepsy for improved care.
Tests a new programme called the 'EpiSafe bundle' in maternity units.
Aims to ensure earlier access to specialist epilepsy care.
Primarily uses routine health data, no extra burden on patients.
Potential for better health outcomes for mothers and babies.
You can opt out of your data being used if you wish.

Who may be eligible?

This study isn't about individual women signing up; instead, it involves different maternity units across the UK. If a maternity unit is taking part in the study, then all pregnant women aged 18 or over who have a confirmed diagnosis of epilepsy and attend that unit for their first antenatal appointment will automatically be included in the study's data collection.

There are a few reasons why a maternity unit might not be part of the study, for example, if they don't have access to dedicated epilepsy specialists or if they already have very strong procedures in place for all pregnant women with epilepsy to get specialist care very early on. Similarly, an individual pregnant woman would not be included if she has a different type of seizure disorder that isn't epilepsy, or if her epilepsy diagnosis wasn't confirmed before she got pregnant. If a woman decides she doesn't want her health data to be used in the study, she can also choose to opt out through the NHS system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you pregnant?
Do you have a confirmed diagnosis of epilepsy?
Are you 18 years old or older?
Are you attending an NHS maternity unit in your first trimester?
Do you want your health data to be used for research (or have not opted out)?

Answer every question to see your result.

What does participation involve?

If your maternity unit is chosen to be part of this study, you won't need to do anything extra or different from your usual care. The 'EpiSafe bundle' is designed to become part of the standard care delivery at your antenatal booking visit if your unit is using it. This means that if your unit is using EpiSafe, the midwives will carry out a short quick check to see if you're at a higher risk due to your epilepsy and refer you to an epilepsy specialist earlier if needed. If your unit is in the group providing 'usual care,' then your care will follow the current standard guidelines.

The study mostly uses routine health information that's already collected as part of your care, so it won't impact your daily life. You won't have extra appointments or need to take any new medications just for the study. Some women with epilepsy and healthcare staff at the units using EpiSafe will also be invited for interviews to share their experiences, but this is optional and separate from your routine care.

Potential risks and benefits

The main benefit of this study could be that more pregnant women with epilepsy, especially those at higher risk, get to see an epilepsy specialist earlier in their pregnancy. This could lead to better management of their epilepsy and potentially improve health outcomes for both mothers and babies. Because the study mainly uses existing health information and the 'EpiSafe bundle' only helps staff to make earlier referrals, there are no expected additional risks for pregnant women taking part. Your care pathway remains the same, with the intervention simply aiming to improve how quickly you connect with specialist teams. Remember, you have the right to opt out of your data being used in the study at any time through the NHS digital data opt-out system.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mid Cheshire Hospitals NHS Foundation Trust
City only
Crewe, England
Wirral University Teaching Hospital NHS Foundation Trust
City only
Wirral, England
Bradford Teaching Hospitals NHS Foundation Trust
City only
Bradford, England
Barts Health NHS Trust
City only
London, England
Northumbria Healthcare NHS Foundation Trust
City only
North Shields, England
Queen Elizabeth Hospital Kings Lynn
Unverified
King's Lynn, England
York and Scarborough Teaching Hospitals NHS Foundation Trust
Unverified
York, England
Blackpool Teaching Hospitals NHS Foundation Trust
Unverified
Blackpool, England
North Cumbria Integrated Care NHS Foundation Trust
Unverified
Carlisle, England
University Hospitals of Leicester NHS Trust
Unverified
Leicester, England
Royal Surrey County Hospital NHS Foundation Trust
Unverified
Guildford, England
Sandwell and West Birmingham Hospitals NHS Trust
Unverified
Smethwick, England

Common questions

What is the 'EpiSafe bundle'?

It's a new programme designed to help maternity units identify pregnant women with epilepsy who are at higher risk and refer them to a specialist earlier in their pregnancy.

Will I know if my maternity unit is using EpiSafe?

Yes, you should see posters or information on a website at participating units explaining the study and how it works.

Do I have to do anything special if I'm in the study?

No, your care will be exactly the same as usual. The study uses existing health information and doesn't require extra appointments or treatments from you.

Can I choose not to be part of the study?

You can opt out of your health data being used in the study through the national NHS digital data opt-out system.

What kind of results are they hoping for?

The hope is that by using EpiSafe, more pregnant women with epilepsy will receive specialist care sooner, leading to better health for them and their babies.

How to find out more

Carmel Moore

carmel.moore@aru.ac.uk +44 (0)1245 684938 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.