Objectives

The primary goal is to compare the risk of major congenital malformations following maternal intake of different antiseizure medications (ASMs) 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 ASMs during pregnancy is associated with an increased risk of birth defects.
At present, though, the information on the teratogenicity of old ASMs 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 ASMs are even less known. This situation prevents a rational approach to the issue of ASM treatment in women of childbearing age. To try to fill this gap, and provide meaningful conclusions with respect to the safety of different ASMs 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 antiseizure medications 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.

Patient enrollment

All women taking antiseizure medications at conception are eligible for inclusion whether the indication for treatment is epilepsy or other disorders. Recruitment is carried out by Reporting physicians after gathering two distinct informed consents from the enrolled patients, namely an informed consent for the participation to the study and another one for the data processing, as required by the EURAP core protocol.

To ensure anonymity, the patients’ personal data (date of birth or initials of their names) that may somehow lead to their identification are hidden in the Central Registry’s database and can only be seen by the Reporting physician collecting the data, in its local interface database.

To avoid selection bias, only pregnancies enrolled before foetal outcome is known and within week 16 of gestation can contribute to the prospective study.

Retrospective cases are also collected as they may provide valuable information, but they 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 over the years by donations from Accord Healthcare Ltd, Angelini Pharma, Betapharm Arzneimittel GmbH, Bial, DOC Generici, Ecupharma srl, Eisai Europe limited, GlaxoSmithKline, Glenmark Pharmaceuticals, GW/Jazz Pharmaceuticals, Hikma Portugal, Janssen-Cilag, Johnson & Johnson, Krka, Novartis, Pfizer, Sanofi, S.F Group, Teva, UCB biopharma and Zentiva. In addition, national and regional networks may receive support from the same or other pharmaceutical companies.