Why a pregnancy registry?
The use of antiepileptic drugs (AEDs) during pregnancy has been associated with an increased risk of birth defects. At present, there are many antiepileptic drugs to choose from and it is unclear if some of these drugs are safer to use during pregnancy than others. Indeed, the information on the teratogenicity of old AEDs in humans is presently conflicting, due to inadequate sample size and other shortcomings of the studies completed to date. In addition, the potential harmful effects of newer AEDs are even less known. This situation prevents a rational approach to the issue of AED treatment in women of childbearing age. To try to fill this gap, and provide meaningful conclusions with respect to the safety of different AEDs in pregnancy, it is necessary to gather data from large numbers of patients. And this is best accomplished in an international collaboration.
How is it carried out?
EURAP is an observational study and does not interfere with the treatment prescribed by the patient’s physician. The aim is to collect information concerning risk factors, exposures during pregnancy and pregnancy outcome. The data collected are part of the information that should be generally available during good medical care; the study does not entail any special evaluation procedure or extra visits.
All women taking antiepileptic drugs at conception are eligible for inclusion whether the indication for treatment is epilepsy or other disorders. To avoid selection bias, only pregnancies enrolled before foetal outcome is known and within week 16 of gestation contribute to the prospective study.
Who can contribute?
The EURAP project is open to any physician or research group that can comply with the protocol. You may join the network and work directly by enrolling and reporting pregnancies or you may assist in referring interested patients to collaborating physicians in your region. If interested, please visit the site for more detailed information and go to ‘contact EURAP’.