The EMPiRE Study – Anti-Epileptic drug Monitoring in PREgnancy: an evaluation of effectiveness, cost-effectiveness and acceptability of monitoring strategies.
Researchers at the Women’s Health Research Unit at Queen Mary University of London are currently undertaking the EMPiRE study. They are working in collaboration with centres in Birmingham to find out the best way of managing seizure control in pregnancy. This is the largest international trial to date in pregnant women with epilepsy. It aimed to recruit 1,000 women from 50 maternity units across the UK. The study is funded by the NHS and is supported by Epilepsy Action, a charity dedicated to representing and helping people with epilepsy.
Pregnant women who had epilepsy and were taking one or more of the following anti-epileptic drugs: carbamazepine, lamotrigine, levetiracetam or phenytoin were eligible to take part in the study. Women recruited to EMPiRE were seen as usual in a hospital antenatal clinic and had regular blood tests. These were taken approximately every four weeks up until six weeks after they give birth to measure the levels of antiepileptic drug in their blood. They were also be asked to complete a daily seizure diary.
The study recruited women until August 2014.
Professor Khalid Khan is Chief Investigator for EMPiRE and is keen raise awareness of the study with doctors and pregnant women with epilepsy:
‘‘The EMPiRE study is long awaited and will provide definitive answers on the best method to manage pregnant women with epilepsy on anti-epileptic drugs. Currently these mothers have dual concerns: the risk of worsening seizures in pregnancy and the effect of the drugs on their babies. We are pleased to say that we have had overwhelming support both from clinicians and mothers alike for participation in the study. We hope to provide answers on the most effective and safe method of managing epilepsy in pregnancy.’’
Further information relating to this research can be found at:
- This project was funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 09/55/38) and will be published in full in Health Technology Assessment.
- The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.