NAPES Study
Research type
Research Study
Full title
Neurodevelopment After Exposure in Pregnancy to Seizures (NAPES) Study
IRAS ID
232507
Contact name
Rebecca Bromley
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
This study proposes to investigate whether there is an effect on a child’s development if their mother had seizures during pregnancy. It is important to understand any potential risks to the foetus so that women with epilepsy and their doctors can make fully informed decisions about the best treatment approach during pregnancy.
This study would recruit women before and during pregnancy and follow up the child at 12 months of age with a formal developmental assessment. Only women taking levetiracetam or lamotrigine as their primary medication would be suitable for this study as currently these drugs are thought to carry to lowest risk to the developing foetus. The person conducting the assessment would not know whether the child was exposed to seizures or the medication the mother was on. The neurodevelopmental assessments would be completed in the child’s home.
The results would be made available at the end of the study and it would be expected that the study results would be utilised immediately by women and their doctors. In the longer term this data would be used with data from other studies refine our knowledge on this issue, for example longer-term follow up or the establishment of larger groups of children to study.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0261
Date of REC Opinion
23 Apr 2018
REC opinion
Favourable Opinion