Hjem
Bergen Epilepsy Research Group (BERG)

Varselmelding

There has not been added a translated version of this content. You can either try searching or go to the "area" home page to see if you can find the information there
NordForsk project

SCAN-AED: Nordic register-based study of antiepileptic drugs in pregnancy

SCAN-AED is investigating the association between in utero exposure to antiepileptic drugs and folic acid supplements, and later disease in the mother and child.

Photo
Foto/ill.:
colourbox.com

SCAN-AED is a NordForsk funded Nordic multi-registry study aiming to find the optimal choice of antiepileptic drugs (AEDs) and folic acid treatment during pregnancy. We will examine the risk of physical and neuropsychiatric disease in the child after exposure to different antiepileptic drugs taken alone or in combination during pregnancy. We will also investigate how high dose folic acid modifies this risk. Maternal health during and after pregnancy will also be studied.

Background

Uncontrolled epileptic seizures during pregnancy pose a risk both for the mother and child. Therefore, most women with epilepsy who are using antiepileptic drugs (AEDs) before conception need to do so during pregnancy as well. Unfortunately, many AEDs increase the risk of pregnancy complications and have teratogenic effects. Some AEDs cause major congenital malformations, autism spectrum disorders and impaired development in children exposed in utero. Women with epilepsy are advised to take a dose of folic acid up to 10 times higher than other women, based on the hypothesis that this might reduce the harmful effects of AEDs on the child. However, the efficacy and safety of this treatment strategy is not clear.

Several great joint international efforts have been made to shed light on the adverse effects of AEDs during pregnancy, but there are important unresolved questions due to the lack of statistical power in previous studies. SCAN-AED is a Nordic multi-register study aiming to find the optimal choice of AED and folic acid treatment during pregnancy. More specifically, we aim to examine the risk of physical and neuropsychiatric disease in the child after exposure to different antiepileptic drugs taken alone or in combination during pregnancy. We will also investigate how high dose folic acid modifies this risk. Maternal health during and after pregnancy will also be examined.

The project is a collaboration between epilepsy- and register-based research environments at Aarhus University (Denmark), University of Bergen (Norway), the National Institute for Health and Welfare (Finland) and Karolinska Institutet (Sweden). Data from Iceland will also be included. All five countries have similar population registries that can be linked by the personal identification number. The registers cover almost 20 million people, of whom about 120 000 will have active epilepsy. By linking the medical birth registries with information on maternal medication from the prescription registries, socioeconomic data from the National statistical institutions, and ICD codes for mothers and offspring from the patient registries, we will have an unselected material with very large statistical power that can be adjusted for important confounding factors. We will therefore be able to investigate the association between in utero exposure to various AED regimes and folic acid supplement doses, and later disease in the child and the mother. This study will thereby fill the knowledge gaps in international guidelines for pregnant women with epilepsy.

Collaboration

BIOS (core facility for biostatistics and data analysis, UiB)

The Norwegian Institute of Public Health (the NorPreSS study)

Nordic Microdata Access Network (NordMAN)

Financial support

The project is financed by NordForsk

 

NordForsk logo

 

 

The group members are also funded by the University of Bergen, Helse Vest/Haukeland University Hospital, The Norwegian Epilepsy Association, Torbjørg Hauge’s legacy, Forsberg and Aulie’s legacy, Karolinska Insitutet, Aarhus Universitetssykehus, Universitetet i Aarhus, National Center for Epilepsy at Oslo University Hospital, and the National Institute for Health and Welfare in Finland.

Progress

Timeline 2020
Foto/ill.:
Silje Alvestad

Results and Publications

Publications in peer-reviewed journals:

Management of epilepsy in pregnancy: a report from the International League Against Epilepsy Task Force on Women and Pregnancy Tomson T, Battino D, Bromley R, Kochen S, Meador K, Pennell P, Thomas SV. Epileptic Disord. 2019 Nov 29.

 

Abstracts and presentations:

Scandinavian multi-registry study of antiepileptic drug teratogenicity: the SCAN-AED study. Bjørk MH, Alvestad S, Gilhus NE, Dreier JW, Christensen J, Gissler M, Leinonen M, Tomson T. 11th NorPEN Meeting, Oslo 7-9 Nov 2018.

Scandinavian multi-registry study of antiepileptic drug teratogenicity: the SCAN-AED study. Bjørk MH, Alvestad S, Gilhus NE, Dreier JW, Christensen J, Gissler M, Leinonen M, Tomson T. 5th Congress of European Academy of Neurology, Oslo June 30 – July 2, 2019.

SCAN-AED summaryPart of a joint position paper from the Danish Epidemiological Society, the Danish Society for Pharmacoepidemiology, and Statistics Denmark, 2019.

Nevroutviklingsforstyrrelser hos barn eksponert for valproat, lamotrigin, karbamazepin og levetiracetam i fosterlivet: Resultater fra SCAN-AED: en nordisk multiregister studie. Bjørk MH, Zoega H, Leinonen M, Alvestad S, Cohen JM, Dreier JW, Furu K, Gilhus NE, Gissler M, Hálfdánarson O, Igland J, Sun Y, Tomson T, Christensen J. Abstract for Nevrodagene, Oslo (Oslo, 09-13. March, postponed due to the Corona virus pandemic)

Autism and intellectual disability in children exposed to valproate, lamotrigine, carbamazepine and levetiracetam. Bjørk MH, Zoega H, Leinonen M, Alvestad S, Cohen JM, Dreier JW, Furu K, Gilhus NE, Gissler M, Hálfdánarson Ó, Igland J, Sun Y, Tomson T, Christensen J. Abstract for European Academy of Neurology, Paris 23-26 May 2020.

 

For study participants (in Norwegian)

Dette er en nordisk registerstudie der formålet er å undersøke hvilke medikamentelle behandlingsstrategier i graviditeten som gir best fysisk og psykisk helse for mødre med epilepsi og deres barn. Vi vil koble Medisinsk fødselsregister med Reseptregisteret og Norsk Pasientregister i Norge, og tilsvarende i Sverige, Finland, Danmark og Island, samt innhente sosioøkonomisk informasjon fra de statistiske sentralbyråene. Data kobles av sentrale registermyndigheter og oppbevares trygt på en sikker forskningsserver. Det vil ikke være mulig å spore deltagernes identitet. Barn utsatt for epilepsimedikamenter i fosterlivet sammenlignes med barn uten slik eksponering med tanke på blant annet medfødte misdannelser og autisme. Vi deler barna inn i grupper etter type medikament og bruk av folsyretilskudd i statistiske modeller der også andre faktorer som kan påvirke utfallet tas høyde for. Mødrenes psykiske og fysiske helse under og etter graviditeten undersøkes også. Resultatene vil være fritt tilgjengelig gjennom publisering i åpne vitenskapelige kanaler.

 

Prosjektet er godkjent av regional etisk komité.

 

Ta kontakt

 

Contact

Send e-mail 

Telephone: (+47) 55 58 00 00

Visiting adress: Department of Neurology, Gamle hovedbygning, Jonas Liesvei 71, Haukeland Universitetssykehus

THE RESEARCH TEAM