Pregnant women with epilepsy face a tenfold increase in mortality, yet UK guidelines do not recommend routine monitoring of their anti-epileptic drug levels because the evidence is too weak to support it. This matters because blood levels of anti-epileptic drugs fall during pregnancy due to normal physiological changes, raising the risk of seizures that can be fatal. The EMPiRE trial will recruit 1,000 women from 40 UK centres and randomly assign them to either dose adjustments guided by regular blood tests or adjustments based on clinical symptoms alone. The researchers will also interview women about their experiences and conduct a cost-effectiveness analysis comparing the two strategies. If the trial shows that blood-level monitoring reduces seizure deterioration, it could change NHS guidelines and standard practice for managing epilepsy in pregnancy. That would mean fewer seizures, fewer deaths, and clearer evidence for clinicians who currently lack data to guide dosing decisions. The health-economic analysis will tell the NHS whether the added monitoring is worth the cost.
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Epilepsy affects 0.5-1% of general population. Approximately one third of people receiving AEDs are of reproductive age. There is a 10-fold increase in mortality among pregnant women with epilepsy which greatly exceeds the two to three-fold mortality rate observed in all people with epilepsy. These were invariably a direct consequence of seizures. There is one in 250 pregnancies exposed to anti-epileptic drugs (AEDs). AED exposure in-utero is associated with congenital malformation. The general consensus is that the risks of uncontrolled convulsive seizures in the mother outweigh the potential teratogenic risk from AEDs, and most women with active epilepsy are advised to continue with their medication during pregnancy. The blood levels of various AEDs fall in pregnant women with epilepsy due to physiological changes in pregnancy. Monitoring of serum AED levels in each trimester and after delivery has been recommended by the American Academy of Neurologists. In the UK however, the NICE (National Institute for Health and Clinical Excellence) and SIGN (Scottish Intercollegiate Guidelines Network) guidelines do not recommend regular AED monitoring in pregnancy due to paucity of evidence. EMPiRE is a multicentre randomised controlled trial that aims to evaluate whether AED dose adjustment based on serum AED levels reduces the risk of seizure deterioration in pregnancy compared to management based on clinical factors only. All pregnant women with epilepsy on one or more of the following AEDs: lamotrigine, carbamazepine, phenytoin, levetiracetam will be eligible for recruitment. We aim to recruit 1000 participants from 40 centres throughout the UK. We will qualitatively assess the views and experiences of pregnant women with epilepsy. In addition to that, cost-effectiveness analysis will be undertaken by comparing different management strategies using a decision-analytic model based health economic evaluation.
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