ISRCTN01253916Completed未知
AntiEpileptic drug Monitoring in PREgnancy: an evaluation of effectiveness, costeffectivenessand acceptability of monitoring strategies
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 1,000
Study Overview
Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29737274
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Have signed a consent form before undergoing any trial-related activities
- •2. Have a confirmed viable pregnancy of less than 16 weeks gestation at booking
- •3. Have a confirmed diagnosis of epilepsy (any syndrome: primary, localised or unclassified)
- •4. Currently prescribed lamotrigine monotherapy or polytherapy (with carbamazepine, phenytoin or levetiracetam), carbamazepine monotherapy, phenytoin monotherapy or levetiracetam monotherapy
- •5. Be capable of understanding the information provided, with use of an interpreter if required
Exclusion Criteria
- •1. Be beyond 16 weeks gestation at booking
- •2. Documented non-epileptic seizures in the last 2 years
- •3. Documented of status epilepticus in the last 12 months
- •4. A history of alcohol or substance abuse or dependence in the last 2 years
- •5. Sodium valproate (VPA) monotherapy or polytherapy
- •6. Non lamotrigine polytherapy
- •7. A history of poor AED adherence
- •8. Unable to complete a seizure diary or recall frequency of seizures accurately
- •9. Have a significant learning disability
- •10. Participation in any blinded, placebo-controlled trials of investigational medicinal products in pregnancy
Investigators
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