NIHR-funded project aims to identify women with epilepsy who are at highest risk of seizures and initiate a pathway to specialist antenatal care
Image credit: Volodymyr Hryshchenko, 2019.
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 Epi-Safe 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.
The team 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.
Professor Shakila Thangaratinam, Dame Hilda Lloyd Chair of Maternal and Perinatal Health at the University of Birmingham said:
“Epilepsy causes 1 in 10 of all deaths during pregnancy in the UK, and neurological conditions have become the second highest cause of maternal deaths in the UK, with the numbers rising from approximately 6 per year in 2013 to 11 per year in 2019.
“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 Epi-Safe 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 Epi-Safe 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 Epi-Safe bundle. Charity partners on the programme include Epilepsy Research UK (ERUK) and Epilepsy Action, who will provide invaluable insight and guidance.
Ngawai Moss is a mother of two whose experiences have led her to play an integral role in the establishment of the Epi-Safe 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.
Ngawai said:
“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.
Now it’s a scary time when I first started thinking about getting pregnant
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.
Ngawai said:
“When I did eventually see the consultant it turned out he was just the designated gynaecologist 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.”
Dr John Allotey, women’s health researcher at the University of Birmingham 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 Epi-Safe risk assessment and treatment pathway, that will facilitate early specialist epilepsy care for high-risk women. The team will also evaluate whether Epi-Safe will help more women at high-risk access specialist epilepsy care early in pregnancy.
Rajinder Flora, Assitant 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 Epi-Safe work streams consist of:
About the National Institute for Health and Care Research
Honorary Professor
Staff profile of Professor Shakila Thangaratinam, Honorary Professor at Metabolism and Systems Science (MSS) at the University of Birmingham.
Associate Professor in Epidemiology and Women’s Health
Staff profile of Dr John Allotey, Associate Professor in Epidemiology and Women's Health, in the Department of Metabolism and Systems Science and at the Department of Applied Health Sciences, University of Birmingham.
