Assessing relative risks of fetal malformations following prenatal exposure to old and new antiepileptic drugs: The international EURAP pregnancy registry initiative

Daniela Mamoli, Sara Messina, Emilio Perucca

Research output: Contribution to journalArticle

Abstract

It is estimated that overall 0.3 to 0.4% of all children are born to mothers with epilepsy. While the large majority of these children are born healthy, several studies have shown that maternal exposure to older generation AEDs during the first trimester of pregnancy is associated with an average 4-6% incidence of major birth defects, compared with an incidence of about 2% in the general population. However, comparative risks associated with different AEDs have not been clearly defined and, although polytherapy seems to be more teratogenic than monotherapy, relative risks associated with specific AED combinations have not been adequately assessed. The teratogenic potential of newer generation AEDs is also unknown. To address these gaps in knowledge, a prospective international pregnancy registry (EURAP) has been set up, whose objectives include the evaluation of the relative teratogenic risk associated with specific AEDs and their combinations, and identification of potential factors affecting or modifying this risk. All women exposed to AEDs at the time of conception are eligible for entry. The protocol is purely observational and does not entail any change in physician's management policies. Data from prospective monitoring for up to 1 year after birth are entered into a central database. Risk assessment is based exclusively on cases enrolled before fetal outcome is known (and in any case not after the 16th week of pregnancy). EURAP is operating in 23 countries with over 1,600 pregnancies recruited to date, and collaboration from interested physicians worldwide is welcome. This initiative is expected to lead to major advances in pre-pregnancy counselling and clinical management of women with epilepsy.

Original languageEnglish
Pages (from-to)114-119
Number of pages6
JournalActa Neurologica Taiwanica
Volume11
Issue number3
Publication statusPublished - Sep 2002

Fingerprint

Anticonvulsants
Registries
Pregnancy
Epilepsy
Physicians
Maternal Exposure
Incidence
First Pregnancy Trimester
Counseling
Mothers
Parturition
Databases
Population

Keywords

  • Antiepileptic drugs
  • Epilepsy
  • Fetal malformations
  • Pregnancy
  • Registry
  • Teratogenicity

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

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abstract = "It is estimated that overall 0.3 to 0.4{\%} of all children are born to mothers with epilepsy. While the large majority of these children are born healthy, several studies have shown that maternal exposure to older generation AEDs during the first trimester of pregnancy is associated with an average 4-6{\%} incidence of major birth defects, compared with an incidence of about 2{\%} in the general population. However, comparative risks associated with different AEDs have not been clearly defined and, although polytherapy seems to be more teratogenic than monotherapy, relative risks associated with specific AED combinations have not been adequately assessed. The teratogenic potential of newer generation AEDs is also unknown. To address these gaps in knowledge, a prospective international pregnancy registry (EURAP) has been set up, whose objectives include the evaluation of the relative teratogenic risk associated with specific AEDs and their combinations, and identification of potential factors affecting or modifying this risk. All women exposed to AEDs at the time of conception are eligible for entry. The protocol is purely observational and does not entail any change in physician's management policies. Data from prospective monitoring for up to 1 year after birth are entered into a central database. Risk assessment is based exclusively on cases enrolled before fetal outcome is known (and in any case not after the 16th week of pregnancy). EURAP is operating in 23 countries with over 1,600 pregnancies recruited to date, and collaboration from interested physicians worldwide is welcome. This initiative is expected to lead to major advances in pre-pregnancy counselling and clinical management of women with epilepsy.",
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