- NIHR-funded project aims to identify women with epilepsy who are at highest risk of seizures and initiate a pathway to specialist antenatal care.
- Case study: I had to fight just to get any specialist care, mum of two says
- While 1 in 250 women who give birth in the UK have epilepsy, 1 in 10 of women who die during or after childbirth have epilepsy.
- Project will also study the long-term neurodevelopment of children exposed to the newer anti-epileptic drugs while they were in the womb.
Pregnant women with epilepsy could see a major improvement in the care they receive and reduce maternal mortality risk through a new project led by the University of Birmingham.
The EpiSafe project, funded by the National Institute for Health and Care Research over five years, will create and trial an evidence-based, personalised care bundle specifically designed for pregnant women with epilepsy.
The team of researchers, led by Professor Shakila Thangaratinam from the University of Birmingham, will provide healthcare professionals caring for pregnant women with epilepsy, the tools and guidance they need to streamline the care they provide and allow for shared decision-making with women regarding their epilepsy and pregnancy.
At a parliamentary event hosted by former Health Minister Baroness Cumberlege to mark the early stages of the project, patients and researchers explained about how important this project is for ensuring that women across the UK get a say in managing epilepsy during pregnancy.
Addressing the event, Baroness Cumberlege said:
“Being pregnant is a very important stage for every woman, conscious that if all goes well she is bringing new life into the world. The EpiSafe programme is crucial in creating evidenced based pathways which must ensure the voices and experience of women directly shape solutions. The success of this programme will only be realised if there is meaningful collaboration between researchers, clinicians, and women with epilepsy and their families. Cooperation is vital to spur change.
“All those involved in the care of pregnant women have a duty to safeguard the wellbeing of all mothers with chronic health needs. I will follow the progress of innovations borne from initiatives such as this closely, and with the help of others advocate tirelessly for their swift translation into enhanced standards of care.”
Anti-epileptic drugs and children's development
The EpiSafe project will also study the long-term effects of newer anti-epileptic drugs (AEDs) on children's development. Many mothers are prescribed these newer AEDs due to concerns with older medications, yet they often discontinue them out of fear of potential harm to their baby.
As part of this study, the researchers at University of Birmingham will bridge the knowledge gap by assessing the long-term neurodevelopmental outcomes of children exposed to newer AEDs during pregnancy. This research will empower pregnant women with epilepsy, enabling them to make informed decisions about the safe use of AEDs.
Epilepsy continues to be one of the main causes of mothers dying in pregnancy and postpartum periodProfessor Shakila Thangaratinam
Professor Shakila Thangaratinam, Dame Hilda Lloyd Chair of Maternal and Perinatal Health at the University of Birmingham and Consultant Obstetrician at Birmingham Women’s and Children’s NHS Foundation Trust said:
“Epilepsy continues to be one of the main causes of mothers dying in pregnancy and postpartum period. Sadly, we are not observing a fall in maternal deaths. On the contrary, there has been a doubling of the rates of Sudden Unexpected Death in Epilepsy (SUDEP) in mothers between 2013-15 and 2019-21 in UK and Ireland.
“We know that the primary factors contributing to these poor maternal outcomes are the lack of specialist antenatal care and reduced compliance with anti-seizure medication. The EpiSafe programme of work has the potential to improve the care these women receive and save lives within this high-risk group.”
At the core of the EpiSafe programme are mothers with lived experiences of epilepsy from diverse backgrounds. They will play a pivotal role throughout the lifetime of the programme in shaping the development and roll-out of the EpiSafe bundle. Charity partners on the programme include Epilepsy Research Institute and Epilepsy Action, who will provide invaluable insight and guidance.
I had to fight to get the care I needed
Ngawai Moss is a mother of two whose experiences have led her to play an integral role in the establishment of the EpiSafe project.
Diagnosed with epilepsy at the age of 11, Ngawai had managed seizures well during her teens and 20s. Still, she vividly remembered the conversation with her GP when she was informed of her condition. This early discussion sparked a ripple effect throughout her life, as she contemplated motherhood, navigated the healthcare system, and ultimately participated in the EMPIRE trial.
“I was told that if I ever wanted to get pregnant, I must first get checked up and see a neurologist because “the medication you’re on is not very good if you want to get pregnant.” As a newly diagnosed 11 year old it scared the life out of me.”
When Ngawai was considering becoming a mum for the first time, she remembered this conversation and urged her newer GP to refer her for a consultation with a neurologist. Unusually for that time, the hospital provided a preconception care pathway for women with epilepsy, and she ended up being invited to join the EMPIRE trial. Participating in the trial provided her with an additional level of clinical support to manage medications.
Ngawai explained that the decision to have a baby and the process to getting pregnant was “worrying”:
“Now it’s a scary time when I first started thinking about getting pregnant. It took me several years just to sort out the kind of medication that would work for me. I was worried about how this would affect my fertility and if I could even get pregnant.
“I was on sodium valproate at the time and despite communicating my concerns about the risks to the baby, the neurologist advised me to just lower the dose. I wasn’t happy but I went along with it, you assume they are the experts and they know something you don’t.
Sadly, I ended up miscarrying. By this point my epilepsy nurse specialist from the preconception pathway took the initiative and we tried different medications, but I just remember thinking ‘at least I can get pregnant’.
“I pretty much took part in the clinical trial to get the additional appointments offered to all the women – it was my first child and I had no idea.”
Ngawai explains that her experience on the clinical trial has had a huge bearing on how she accessed care when she planned a pregnancy for her second child:
“When I became pregnant with my second child, I had moved and was based at a different hospital. I had learned a lot from being on the trial so I knew what I needed as a woman with epilepsy. I got in touch to get some additional support but there was no pathway for higher risk women.”
Despite knowing about some of the nuances required for her care, no one seemed to listen. For example, she asked to see a consultant or specialist earlier in the process so they could manage her medication dosage but was told to ask the sonographers during her 12-week scan instead.
“When I did eventually see the consultant it turned out he was just the designated obstetrician for epilepsy cases and had no particular expertise in epilepsy. I was really angry at the time. If this had been my first child I wouldn’t have known any differently, you just accept that’s the way it is, you don’t know what to ask or what you need. This should not be acceptable.
“I fought to get my care moved back to the hospital where I took part in the trial (EMPIRE). But I know that I’m lucky. It shouldn’t be like that for women with epilepsy, to have to know what care we should receive.”
...we will develop an acceptable, relevant and accessible tool which identifies pregnant women with epilepsy who are at high risk and promotes safe use of AEDDr John Allotey
Dr John Allotey, Associate Professor in Epidemiology and Women’s Health at the University of Birmingham and project leader said:
“By working with diverse groups of women with epilepsy and their families, professional bodies, organisations providing care for pregnant women with epilepsy, as well as dedicated epilepsy charities, we will develop an acceptable, relevant and accessible tool which identifies pregnant women with epilepsy who are at high risk and promotes safe use of AED.”
The project consists of six work packages to create the EpiSafe risk assessment and treatment pathway, that will facilitate early specialist epilepsy care for high-risk women. The team will also evaluate whether EpiSafe will help more women at high-risk access specialist epilepsy care early in pregnancy.
The Epilepsy Research Institute’s Director of Research Partnerships, Dr Caoimhe Twohig-Bennett, said:
“The Institute launched last month with Reproduction & Hormones as one of our overarching strategic research theme. We are delighted to be collaborating on the EpiSafe project, to ensure safer care and reduced risks for pregnant women with epilepsy.“Central to the work of the Epilepsy Research Institute is a culture of advocating and actioning the research priorities of people affected by epilepsy through our Shape Network PPIE group. Members of the network have been pivotal in the development of this programme of research, and we look forward to their continued involvement as this important project progresses.”
Rajinder Flora, Assistant Director of NIHR's Programme Grants for Applied Research (PGfAR), which funds the research, said:
"Epilepsy causes 1 in 10 of all deaths during pregnancy in the UK, this new project aims to identify women with epilepsy who are at highest risk of seizures and create a treatment pathway for them.
"Funding research like this is vital to provide evidence-based personalised care for pregnant women with epilepsy"
The EpiSafe team also includes co-applicants from University of Liverpool, University of Manchester, Birmingham City University, University of Aberdeen and Belfast Health and Social Care trust, as well as partnerships with Kings Health Partnership and Murdoch Children’s Research initiative.
The EpiSafe work streams consist of:
- Gathering all evidence needed to design the EpiSafe bundle,
- Co-designing and testing the EpiSafe bundle by working with women and healthcare professionals,
- A randomised controlled trial to see if using the EpiSafe bundle improves care, reduces seizures and complications in mother and baby,
- Studying the longer-term development of children aged 7-11 exposed to AEDs before birth,
- Studying the cost of using EpiSafe and its long-term impact, and
- Planning appropriate involvement and engagement with women with epilepsy and their support networks.