EMPiRE: Antiepileptic Drug Management in Pregnancy

Managing epilepsy while pregnant can be distressing and potentially harmful, which is why many opt to use anti-epileptic drugs to control the seizures. This study aimed to find out if routine blood tests to monitor drug levels in pregnancy is better than management based on only clinical findings.

Empire project large


With assistance from their research team:

S Thangaratinam, N Marlin, S Newton, A Weckesser, M Bagary, L Greenhill,5 R Rikunenko, M D’Amico, E Rogozin, A Kelso, K Hard, J Coleman, N Moss, T Roberts, L Middleton, J Dodds,A Pullen, S Eldridge, A Pirie, E Denny, D McCorry and K. S. Khan on behalf of the EMPiRE Collaborative Network

Research background

EMPiRE was a study on the management of anti-epileptic drugs (AEDs) for women with epilepsy who are pregnant. When a woman with epilepsy is pregnant, it is important that her doctor considers such issues as:

  • choice of AEDs, 
  • risk of seizures to her and the baby while pregnant, 
  • risk of any anti-epileptic drugs to unborn child, and 
  • the increased monitoring and attendance at maternity clinics.

There is very little research on the type of care and treatment that is beneficial to the mother and baby. Therefore, doctors may find it difficult to reliably advise on the best way to treat and manage such patients during this time. The study was funded by the National Institute for Health Research Health Technology Assessment Programme.  

Research aims

The EMPiRE study aimed to find out if routine blood tests to monitor drug levels in pregnancy is better than management based on only clinical findings in preventing seizures and avoiding complications in pregnancy. The study also sought womens views on the two strategies as well as their experiences of managing epilepsy while being pregnant.

Research methods

560 women took part in the RCT and 32 took part in the qualitative study. The qualitative study consisted of narrative interviews and each participant was interviewed twice: once near the end of their first trimester and once after their baby was born. 


The risk of seizures and pregnancy complications as well as infantsbirthweight and mothersquality of life were similar in the group managed by monitoring drug levels regularly and in the group managed based on only clinical findings. We did not identify a link between an increase in seizures and a decrease in drug levels.  Women reported that the decisions that they make regarding epilepsy medication intake and dose are influenced by their feelings of responsibility for the health of their babies.  EMPiRE findings do not support regular blood monitoring of antiepileptic drug levels in pregnancy.