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

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.

In May 2021, SCAN-AED and NorPreSS arranged the “International conference on antiepileptic drugs in pregnancy and risk for mother and child”. The conference was held in a digital format and gathered about 200 participants from 17 countries. Their professional backgrounds spanned from researchers, clinicians, pharmacologists, pharmacovigilance experts, and more. The program included presentations from the patient organization, young researchers, and leading scientists and clinicians in the field. The topics of the different sessions spanned from basic concepts of teratogenicity, methodological aspects, clinical aspects such as pharmacology, neurodevelopment, maternal morbidity and folate supplementation, as well as scientific presentations from SCAN-AED, NorPreSS and others. The conference received excellent feedback in the post-conference survey.

In May 2021, SCAN-AED and NorPreSS arranged the “International conference on antiepileptic drugs in pregnancy and risk for mother and child”. The conference was held in a digital format and gathered about 200 participants from 17 countries. Their professional backgrounds spanned from researchers, clinicians, pharmacologists, pharmacovigilance experts, and more. The program included presentations from the patient organization, young researchers, and leading scientists and clinicians in the field. The topics of the different sessions spanned from basic concepts of teratogenicity, methodological aspects, clinical aspects such as pharmacology, neurodevelopment, maternal morbidity and folate supplementation, as well as scientific presentations from SCAN-AED, NorPreSS and others. The conference received excellent feedback in the post-conference survey.

The project is financed by NordForsk (external link)

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.