Exploring the effects of anti-epileptic drugs on fetal neurological development
The Biomarkers of Neurological Disease in Utero Study
This study looks at how anti-epileptic drugs taken during pregnancy might affect the brain development of unborn babies to help identify risks and improve outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Nottingham University Hospitals NHS Trust Academic / other |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Trial ID | NCT04043572 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the teratogenic effects of anti-epileptic drugs (AEDs) on fetal neurological development using fetal magnetic resonance imaging (MRI). It aims to identify biomarkers and understand the onset of abnormalities related to AED exposure during pregnancy. By examining the structural and functional changes in the fetal brain, the study seeks to improve risk stratification and identify candidates for early intervention to enhance developmental outcomes. The research addresses a significant public health concern regarding the impact of AEDs on fetal health.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 45 years with singleton pregnancies who are able to provide informed consent.
Not a fit: Patients who are under 18 or over 45 years old, have multiple pregnancies, or have contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved developmental outcomes for children exposed to anti-epileptic drugs in utero.
How similar studies have performed: While the study explores a novel approach using fetal MRI, previous research has highlighted the teratogenic effects of AEDs, indicating a need for further investigation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Singleton pregnancy Age 18 - 45 years BMI \< 50 Able to give informed consent Exclusion Criteria: 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
Where this trial is running
Nottingham, Nottinghamshire
- Nottingham University Hospitals NHS Trust — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Tayyib T Hayat, MRCP PhD
- Email: tayyib.hayat@nottingham.ac.uk
- Phone: +447971903513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.