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Month: December 2023

a pregnant woman in a patterned dress sits on the edge of a hospital bed. a female doctor is speaking to her, with hands clasped.

Epilepsy in pregnancy – new project to create personalised care for at-risk mums

Written by Louise Stanley on . Posted in Inflammation and chronic disease, Maternal health.

Pregnant women with epilepsy could see a major improvement in the care they receive through a new cross-BHP project led by the University of Birmingham with Birmingham Women’s and Children’s Hospitals NHS Foundation Trust (BWC), which also aims to reduce maternal mortality risk.

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 and BWC, will provide healthcare professionals with 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 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 across BHP 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 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.

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.

Parliamentary event

At a parliamentary event to launch the project hosted by former Health Minister Baroness Cumberlege – who chaired key report on harmful side effects of some medicine – 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.”

Eye-safe laser technology to diagnose traumatic brain injury

Written by Louise Stanley on . Posted in Early diagnosis and detection.

Researchers from BHP founder-member the University of Birmingham have designed and developed a novel diagnostic device designed for the early detection of traumatic brain injury (TBI), which works by shining a safe laser into the eye.

Described in Science Advances, the technique is dramatically different from other diagnostic methods and is now expected to be developed into a hand-held device for use in the crucial ‘golden hour’ after TBI, when life-critical decisions on treatment must be made.

The device incorporates a class 1, CE-marked, eye-safe laser and a unique Raman spectroscopy system, which uses light to reveal the biochemical and structural properties of molecules by detecting how they scatter light, to detect the presence and levels of known biomarkers for brain injury.

There is an urgent need for new technologies to improve the timeliness of TBI diagnosis, which is a leading cause of death worldwide. TBI is caused by sudden shock or impact to the head, which can cause mild to severe injury to the brain, and although it needs diagnosis and treatment as soon as possible to prevent further irreversible damage, it is hard to diagnose at the point of injury. Additionally, radiological investigations such as X-ray or MRI are very expensive and slow to show results.

Birmingham researchers, led by Professor Pola Goldberg Oppenheimer from the School of Chemical Engineering, designed and developed the novel diagnostic hand-held device to assess patients as soon as injury occurs. It is fast, precise and non-invasive for the patient, causing no additional discomfort, can provide information on the severity of the trauma, and will be suitable to be used on-site – at the roadside, on the battlefield or on the sports pitch – to assess TBI.

The device works by scanning the back of the eye where the optic nerve sits. Because this nerve is so closely linked to the brain, it carries the same biological information in the form of protein and lipid biomarkers. These biomarkers exist in a very tightly regulated balance, meaning even the slightest change may have serious effects on brain health. TBI causes these biomarkers to change, indicating that something is wrong.

Previous research has demonstrated the technology can accurately detect the changes in animal brain and eye tissues with different levels of brain injuries – picking up the slightest changes.

The device detailed in the current paper detects and analyses the composition and balance of these biomarkers to create ‘molecular fingerprints’. The study details the development, manufacture, and optimisation of a proof-of-concept prototype, and its use in reading biochemical fingerprints of brain injury on the optic nerve, to see whether it is a viable and effective approach for initial ‘on-scene’ diagnosis of TBI.

The researchers constructed a phantom eye to test its alignment and ability to focus on the back of the eye, used animal tissue to test whether it could discern between TBI and non-TBI states, and also developed decision support tools for the device, using AI, to rapidly classify TBIs.

The device is now ready for further evaluation including clinical feasibility and efficacy studies, and patient acceptability.

The researchers expect the diagnostic device to be developed into a portable technology which is suitable for use in point-of-care conditions capable to rapidly determine whether TBI occurs as well as classify whether it is mild, moderate or severe, and therefore, direct triage appropriately and in timely manner.