European Registry of Antiepileptic Drugs and Pregnancy (EURAP)
Background:
The use of antiepileptic drugs during pregnancy is associated with an increased risk of birth-defects in the offspring. However, for most women with epilepsy it is advisable to continue to take antiepileptic drugs during pregnancy since uncontrolled seizures may be hazardous to the foetus as well as to the pregnant women. In the vast majority of such cases, the outcome is uneventful. There are now many antiepileptic drugs to choose from but it is presently unclear if some of these drugs are more safe to use during pregnancy than others. A number of European research groups have therefore agreed on a common protocol for a prospective assessment of pregnancy outcome after prenatal exposure to antiepileptic drugs and to establish a registry of antiepileptic drugs and pregnancy.
Aim:
The aim of this registry is to obtain information on the risks associated with the use of antiepileptic drugs during pregnancy. The primary objective is to evaluate and determine the comparative degree of safety of the different drugs in the human foetus, in order to identify the most safe drugs and to determine how antiepileptic drugs should be used and dosed to minimise risks.
Inclusion criteria:
All women taking antiepileptic drugs at time of conception may be included irrespective of whether the indication for treatment is epilepsy or other disorders. In order to avoid selection bias, cases should be ascertained as early as possible and no later than during the 16th week of gestation, and always before any foetal outcome is known.
Methods:
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 to be entered in the registry are part of the information that should be generally available during good medical care, and the study does not entail any special evaluation procedure or extra visits The pregnancies are actively monitored and separate reports are given for the three trimesters, and the off-spring is followed up until one year of age. The protocol prescribes a minimum of 2-3 visits during pregnancy, an additional visit three months after birth and a final follow-up 12 months after birth.
The teratogenic endpoints of the core protocol of the study are the presence or absence of major congenital malformations and delay in prenatal growth.
Organisation:
National and regional net-works of collaborating physicians are presently being established in six regions including a total of 19 European countries. Some non-European regions such as Australia have decided to use the same protocol and join the collaboration. The organisation of the net-work varies with the conditions of the health-care system in the region where they operate. Some regions build their net-works on collaborating neurologists, others on GPs or obstetricians. Each region has its own regional co-ordinator and registry, which reports to the central EURAP registry. The data on individual pregnancies will be registered in an anonymous way in order to guarantee confidentiality. Half-yearly progress reports will be prepared and released by the Central Project Commission of EURAP. These will be presented in a way that protects against identification of individual mothers or children.
Who can contribute?
Physicians caring for women taking antiepileptic drugs during pregnancy, and who are interested in contributing to this important study are encouraged to contact the co-ordinator of their region to obtain more information.
Members of the Central Project Commission of EURAP
Dr Torbjörn TomsonChairman of the Central Project Commission of EURAP
Department of Neurology
Karolinska Hospital
S-171 76 STOCKHOLM, Sweden
Tel.: +46 8 517 737 05
Fax: +46 8 517 737 57
e-mail: torbjorn.tomson@ks.se
Dr Dina Battino
Central Study Coordinator of EURAP
Neurological Institute Carlo Besta
Via Celonia 11
201 33 MILAN, Italy
Tel.: +39 02 2394230
Fax: +39 2 700 429160
e-mail: dbattino@istituto-besta.it
Professor Marc Beaussart
Lille, France
Professor Dick Lindhout
Utrecht, The Netherlands
Dr John Craig
Belfast, UK
Professor Emilio Perucca
Pavia, Italy
Professor Erminio Bonizzoni
Pavia, Italy
Professor Frank Vajda
Melbourne, Australia
Dr Anne Sabers
Dianalund, Denmark
Members of the Scientific Advisory Board of EURAP
Professor Martin J BrodieGlasgow, Scotland
Dr Bernd Schmidt
Freiburg, Germany
Members of Outcome Assessment Committee
Professor Richard FinnellHouston, USA
Dr Francesca Faravelli
Genoa, Italy
National Coordinators of EURAP
An international Registry of Antiepileptic drugs and pregnancyAustralia
Professor Frank VajdaAustralian Centre for Clinical
Neuropharmacology
St Vincent Hospital
FITZROY VIC 3065
Tel: +61 (3) 9288 3555
Fax: +61 (3) 9288 3527
e-mail: vajdafj@svhm.org.au
Austria
Dr Gerhard LuefUniversitätsklinik für Neurologie
Anichstrabe 35
A-6020 INNSBRUCK
e-mail: gerhard.luef@uibk.ac.at
Be-ne-lux
Professor Dick LindhoutDepartment of Medical Genetics, KC 04.084.2
University Medical Centre Utrecht
P.O.Box 85090
NL-3508 AB UTRECHT, The Netherlands
Tel: +31 30 250 3821
Fax: +31 30 250 5301
e-mail: d.lindhout@dmg.azu.nl
Croatia
Dr Dinko VitezicDept of Pharmacology
University of Rijeka Medical School
Brace Branchetta 20/1
RIJEKA HR-51000
e-mail: vdinko@medri.hr
Czech Republic
Dr Jana ZarubovaHospital S. Joao
Videnska 800
4-14059 Prag
e-mail: zarubova@ftn.cz
Denmark
Dr Anne SabersDanish Epilepsy Hospital
Dianalund
DK 4293 Dianalund
Tel: +45 58265050
e-mail: kfansa@vestamt.dk
France
Professor Marc BeaussartUniversity Group Research Group in Epilepsy
Lille III -
11, Ave. Pres. J. Kennedy
598 00 LILLE
Fax: +33 32009 4124
e-mail: lille.aispace@wanadoo.fr
Germany
Dr Bettina SchmitzNeurologische Klinik
Campus Virchow Klinikum
Charité
Augustenburger Platz 1
D-13353 BERLIN
Fax: 49 30 450 60901
e-mail: bettina.schmitz@charite.de
Georgia
Lela SturuaEpilepsy Centre Institute of Neurology
2a Gudamakary
TBLISI 380092
e-mail: tgers@access.sanet.ge
Otar Toidze
Epilepsy Centre Institute of Neurology
2a Gudamakary
TBLISI 380092
e-mail: ctma@ctma.com.ge
Hungary
Dr Gábor BarcsHiete-Opni
Huvösvölgyi ut 116
1021 Budapest
e-mail: h1219hal@helka.iif.hu
India
Dr Sanjeev V. ThomasDept of Neurology
SCTIMST
Trivandrum 695 011
Tel: +91 471 524468 or +91 471 446895 (after office hours)
e-mail: sanjeev@giasmd01.vsnl.net.in
Ireland
Dr John CraigDept. of Neurology, Ward 21
Royal Victoria Hospital
Grosvenor Road
BELFAST BT12 6Ba
Tel: (01232) 894968
Fax: +44 1232 235256
e-mail: john.craig@royalhospitals.n-i.nhs.uk
Israel
Miri NeufeldEEG and Epilepsy Unit Neurology Dept
Medical Centre
6, Weizmann St
TEL AVIV
e-mail: neufeldm@tasmc.health.gov.il
Italy
Dr Daniela MamoliNeurological Institute Carlo Besta
Via Celonia 11
201 33 MILANO
Tel: +39 02 2394230
e-mail: dbattino@istituto-besta.it
Norway
Karl-Otto NakkenThe National Centre for Epilepsy
Postbox 900
N-1303 SANDVIKA
Tel: +47 6755 4000
Fax: +47 6754 0496
e-mail: karl-otto.nakken@epilepsy.no
Poland
Dr Piotr HinczPolish Mothers' Memorial Hospital
Dept of Fetal-Maternal Medicine
Rzgowska 281/289 Str
03-338 LODZ
e-mail: phincz@plusnet.pl
Dr Joanna Jedrzejczak
Polska Liga Przeciwpadaczkowa - Ffundacja Epileptologii
Ul. Wiertnicza
02-952 Warszawa
e-mail: Office@epilepsy.org.pl
Scotland
Professor Martin J BrodieDirector, Epilepsy Unit
University Department of Medicine & Therapeutics
Western Infirmary
Glasgow, G11 6NT
Tel: +44 141 211 2572/2944
Fax: +44 141 334 9329
e-mail: Martin.J.Brodie@clinmed.gla.ac.uk
Spain
Dr. Meritxell Martinez FerriUnidad de Epilepsia. Servicio de Neurología
Hospital Clinic
C/ Villarroel 170
08036 Barcelona (Spain)
Tel: +34 93 2275400 ext:2839
Fax: +34 93 2279311
e-mail: med028321@saludalia.com
Sweden
Dr Torbjörn TomsonDepartment of Neurology
Karolinska Hospital
S-171 76 Stockholm
Tel: +46 8 51773705
Fax: +46 8 51773705
e-mail: torbjorn.tomson@ks.se
Switzerland
Dr Barbara TettenbornChief of the Department of Neurology
Kantonssspital St. Gallen
CH-9007 ST. GALLEN
Tel: +41 71 494 1652
Fax: +41 71 494 2895
e-mail: barbara.tettenborn@kssg.ch
Dr Ritva Sälke-Kellerman
Swiss Epilepsy Clinic
Bleulerstr. 60
CH-8008 Zurich
e-mail: ritva.salke@swissepi.ch
Turkey
Dr Cigdem ÖzkaraDept of Neurosurgery
Cerrahpasa School of Medicine
University of Istanbul
34303 ISTANBUL
Tel. & Fax: +90 212 6330176
e-mail: cigdemoz@istanbul.edu.tr
UK
Dr John CraigDept. of Neurology
Ward 21
Royal Victoria Hospital
Grosvenor Road
BELFAST BT12 6BA
Tel: +44 1232 894968
Fax: +44 1232 235256
e-mail: john.craig@royalhospitals.n-i.nhs.uk
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