NOCT Study
Research type
Research Study
Full title
Neurodevelopmental Outcomes in Children exposed to Topiramate in the Womb
IRAS ID
256953
Contact name
Anja Wittkowski
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Epilepsy is a condition that causes seizures. It is usually treated with medicine. Women with epilepsy who are pregnant often have to continue taking epilepsy medicine throughout pregnancy, as seizures can harm both mother and baby. Research finds that, when taken during pregnancy, certain epilepsy medicines can be harmful to the development of babies in the womb. Women are now offered newer epilepsy medicines, such as topiramate. However, little is known about the impact of topiramate on babies in the womb and whether this medicine interferes with brain development. This limits women and prescribers alike in making informed decision about epilepsy treatment.
The current study will investigate whether children exposed to topiramate in the womb differ in their development compared to a control group. 102 women with epilepsy will be recruited, all of whom have children aged 3-16 years. Half of the mothers in the sample will have taken topiramate throughout pregnancy. The remaining mothers will have had no epilepsy medicine during pregnancy and will be the control group. The sample will be recruited from a research register (UK Epilepsy and Pregnancy Register) owned by Belfast Health and Social Care Trust. Women with epilepsy across the UK voluntarily enroll onto the register during pregnancy.
Participation in the research will take place via telephone interviews, requiring a maximum of one hour's time per participant. The interview will initially involve taking a history of the child's development and obtaining maternal/paternal information. The second part of the interview will involve questions about the child's communication, socialisation and daily living, all of which can be termed adaptive behaviour skills. The data gained from interviews will be analysed to determine whether there is an association between exposure to topiramate in the womb and the development of adaptive behaviour skills when other influencers are adjusted for.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
19/NW/0299
Date of REC Opinion
8 Aug 2019
REC opinion
Further Information Favourable Opinion