Status:
UNKNOWN
The Biomarkers of Neurological Disease in Utero Study
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborating Sponsors:
University of Nottingham
Conditions:
Epilepsy
Neurodevelopmental Disorders
Eligibility:
FEMALE
18-45 years
Brief Summary
Anti-epileptic drugs (AEDs) are potent teratogens associated with a spectrum of physical and neurodevelopmental anomalies to the exposed fetus. Particular risks include congenital malformations, impai...
Detailed Description
BACKGROUND There are approximately 50 million people with epilepsy worldwide, with approximately 3-5 births per thousand to women with epilepsy; in the United Kingdom (UK) there are 2500 births per ye...
Eligibility Criteria
Inclusion
- Singleton pregnancy Age 18 - 45 years BMI \< 50 Able to give informed consent
Exclusion
- Multiple pregnancy Age less than 18 or greater than 45 years old BMI \> 50 Unable to give informed consent Contraindication to MRI Refractory seizures Seizure(s) within last 30 days Unstable for transfer to MRI
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04043572
Start Date
June 1 2019
End Date
October 1 2025
Last Update
October 8 2020
Active Locations (1)
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1
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH