Authors :
Presenting Author: Rebecca Bromley, PhD – University of Manchester
Matthew Bluett-Duncan, PhD – University of Manchester
Michelle Dower, RN – Liverpool Women's Hospital NHS Foundation Trust
Marta Garcia-Fiñata, PhD – University of Liverpool
Craig Heath, MD – NHS Greater Glasgow and Clyde
Beth Irwin, RN – Belfast Health and Social Care Trust
Graeme Sills, PhD – University of Glasgow
Ngawai Moss, BSc – Queen Mary University of London
Aoife O'Sullivan, BSc – University of Manchester
Victoria Taylor, BSc – University of Manchester
John Craig, MBBS – Belfast Health and Social Care Trust
Rationale:
Pregnancy and epilepsy registers were established to conduct surveillance for offspring major congenital anomalies following exposure to antiseizure medications (ASMs). Few include routine longitudinal follow up to assess other later emerging child health and neurodevelopmental outcomes. The LIFETIME framework was developed as part of the ConcePTION Study (https://www.imi-conception.eu/results/) to improve the monitoring of diverse child outcomes in pregnancy and breastmilk exposure-related pharmacovigilance studies. The LIFETIME Framework was adopted into the UK Epilepsy and Pregnancy Register to pilot both surveillance (screening questionnaires) and enhanced level (blinded, researcher led) investigations as a routine part of the Register’s activities.Methods:
Recruitment took place at two clinics and nationally online via the UK Epilepsy and Pregnancy Register website from October 2023 to December 2024. Women were recruited during pregnancy and provided health and demographic information prospectively via online questionnaires or over the phone. Birth and child health data were collected through completion of an expert-developed health questionnaire at 3, 6, 12 and 24 months of age. Validation of pregnancy and birth information was completed for women recruited via the two clinics. Child early neurodevelopmental progress was measured via the Ages and Stages Questionnaires, 3rd Edition at 6, 12 and 24 months of age. Additionally, at 24 months of age, the Bayley’s Scale of Infant and Toddler Development will be administered to provide a blinded and standardised assessment of the child’s abilities, which forms the enhanced investigation stream.
Results:
201 pregnant women were recruited, with 188/201 (94%) providing data. ASMs included 123 monotherapy, 45 duotherapies, 11 polytherapy and 9 women where no medication was taken. These numbers included rarer ASM exposures such as clobazam, cenobamate, zonisamide, lacosamide and brivaracetam. Rates of follow up remained high with third trimester data provided by 115/125 (92%) and 124/140 (89%) regarding birth outcomes. This cohort is still under follow up, but currently 92/111 (83%) completed the questionnaire on child health and breastfeeding status at 3 months. The Ages and Stages Questionnaire was completed in 70/88 (80%) at 6 months and 20/24 (83%) at 12 months.
Conclusions:
A dual model of both surveillance and enhanced investigations offers the opportunity to routinely collect screening level child health and neurodevelopmental outcome data across large geographical regions, alongside more enhanced researcher-led data collection for subpopulations. Implementing longitudinal routine child health and neurodevelopmental investigations into already established initiatives such as Epilepsy and Pregnancy Registers will improve available data regarding the safe use of ASMs in women of reproductive age.
Funding:
This work has received support from the EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking ConcePTION grant no. 821520 and the UK Epilepsy Research Institute grant no. DC2406.