Pilot extension to the UK Epilepsy and Pregnancy Register
Research type
Research Study
Full title
Child neurodevelopment following prenatal exposure to antiseizure medications: a pilot extension to the UK Epilepsy and Pregnancy Register
IRAS ID
298187
Contact name
Alison Murphy
Contact email
Sponsor organisation
Belfast Health and Social Care Northern Ireland
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 28 days
Research summary
In the UK women with epilepsy give birth to approximately 2,500 babies each year. Women with epilepsy worry about the potential impact of antiseizure medications, particularly with regards to their baby’s health. This uncertainty continues after birth with many women opting to avoid breastfeeding.
The UK Epilepsy and Pregnancy Register has been researching the children of women with epilepsy for over 2 decades, but our current follow up stops 3 months after the birth. We want to understand if we can follow up participating women with epilepsy for longer to learn about breastfeeding and the development of their children. This pilot study will replace the previously running UK Epilepsy and Pregnancy Register.Women will tell us about their health and pregnancy at set points during the pregnancy and following the birth of their child using either web-based questionnaires, over the phone or via post (their preference). At two years of age a face-to face developmental assessment will be completed with the child, masked to any knowledge of whether the child was exposed to a medication or not in the womb.
We will also investigate women’s willingness for us to combine anonymised data (e.g. child developmental scores, health history and medication information) with other similar datasets from around the world. Being able to do this will improve our knowledge about less frequently used or new antiseizure medications.
We will investigate whether this system of longer term follow up is feasible, what resources are needed and collect feedback from the women who take part. The results will inform the future design of the UK Epilepsy and Pregnancy Register.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
23/NW/0066
Date of REC Opinion
16 May 2023
REC opinion
Further Information Favourable Opinion