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.
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 is established and carried out under the auspices of the European Epilepsy Academy (EUREPA) and is endorsed by the Commission on Therapeutic Strategies of the International League Against Epilepsy (ILAE).
EURAP is supported by educational grants to the CPC from GlaxoSmithKline, Janssen-Cilag, Pfizer, Sanofi-Synthelabo, UCB Pharma and Novartis. National networks may also receive support in the form of unrestricted grants from other pharmaceutical companies.