EURAP is a prospective observational study of pregnancies with antiepileptic drugs (AEDs).
It was launched in Europe in 1999 by a consortium of independent research groups and later extended to several other nations worldwide. The aim was to collect data on the risk of antiepileptic drugs during pregnancy and share it in an international registry.
Physicians from 45 countries in Europe, Oceania, Asia, Latin America and Africa have participated to the study and more than 26,000 pregnancies have been registered so far.
EURAP is an international collaboration with the vision to establish a basis for a safer treatment of epilepsy during pregnancy. The primary objective is to compare the safety of different antiepileptic drugs during pregnancy with respect to the risk of birth defects.
The primary goal is to compare the risk of major congenital malformations following maternal intake of different antiepileptic drugs (AEDs) and their combinations. Secondary objectives include the evaluation of:
- any specific pattern of foetal abnormalities
- dose-effect relationships
- other risk factors
Why a pregnancy registry?
The use of AEDs during pregnancy is associated with an increased risk of birth defects.
At present, though, the information on the teratogenicity of old AEDs in humans is 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 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.
All women taking antiepileptic drugs at conception are eligible for inclusion whether the indication for treatment is epilepsy or other disorders. Recruitment is carried out by Reporting physicians after obtaining informed consent as required by the Ethics Committee of the individual country.
To ensure anonymity, each case is identified with only the date of birth of the mother and the first three letters of her surname. To avoid selection bias, only pregnancies enrolled before foetal outcome is known and within week 16 of gestation contribute to the prospective study.
Retrospective cases are also collected as they may provide valuable information but are not included in the comparative risk evaluation.
Who can contribute?
The EURAP project is open to any physician or research group that can comply with the protocol. If interested, please visit the site for more detailed information and go to ‘contact EURAP’.
Funding and support
EURAP is an independent research initiative promoted and implemented by physicians working on a non-profit basis. It is administratively organised by the Central Project Commission (CPC) with members representing different geographical areas and disciplines.
The project was established and carried out under the auspices of the European Epilepsy Academy (EUREPA) and it is endorsed by the Commission on Therapeutic Strategies of the International League Against Epilepsy (ILAE).
EURAP has been supported by educational grants to the CPC from Eisai Pharmaceuticals, GlaxoSmithKline, Janssen-Cilag, Johnson & Johnson, Pfizer, Bial, Sanofi-Synthelabo, Novartis, UCB Pharma, and Ratiopharm. In addition, national and regional networks may receive support from the same or other pharmaceutical companies.