Abstract
Background There is a 10-fold increase in mortality among pregnant women with epilepsy, which greatly exceeds the two to three-fold rate of deaths observed in all people with epilepsy. Risks of uncontrolled convulsive seizures in the mother outweigh potential risk of the medication. The levels of anti epileptic drugs (AEDs) have been shown to reduce during pregnancy. EMPiRE is a randomised controlled trial to determine whether Therapeutic Drug Monitoring reduces risk of seizure deterioration compared to Clinical Features monitoring alone. The trial aims to recruit 1,000 participants. We report on the challenges of recruitment.
Highlights
There is a 10-fold increase in mortality among pregnant women with epilepsy, which greatly exceeds the two to three-fold rate of deaths observed in all people with epilepsy
EMPiRE is a randomised controlled trial to determine whether Therapeutic Drug Monitoring reduces risk of seizure deterioration compared to Clinical Features monitoring alone
We report on the challenges of recruitment
Summary
There is a 10-fold increase in mortality among pregnant women with epilepsy, which greatly exceeds the two to three-fold rate of deaths observed in all people with epilepsy. Building the empire: a multi specialist, multi centre pragmatic trial From 2nd Clinical Trials Methodology Conference: Methodology Matters Edinburgh, UK. Background There is a 10-fold increase in mortality among pregnant women with epilepsy, which greatly exceeds the two to three-fold rate of deaths observed in all people with epilepsy. Risks of uncontrolled convulsive seizures in the mother outweigh potential risk of the medication.
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