EURAP registry in Croatia: prospective follow-up of pregnancies in women treated with antiepileptic drugs

Antiepileptic drugs (AEDs) taken by pregnant women to prevent seizures have been associated with an increased risk of congenital anomalies to the fetus. Although the real magnitude of this increased risk is unknown, some investigations have shown that women with epilepsy who took only one AED during pregnancy had a 3%-6% risk of giving birth to an infant with congenital anomalies compared with a 2% risk in untreated women. The risk is in-creased with polytherapy. After we had performed a retrospective study at the Rijeka University Hospital Center (1993-2002), we observed its limitations, especially because of a small number of pregnancies in one center. To solve this problem, as the only medical center in Croatia, we have joined then Inter-national Antiepileptic Drugs and Pregnancy Registry (EURAP). So, the aim of our work is to present the characteristics of EURAP as well as the results of our patients included in the Registry. We performed a prospective analysis according to the EURAP protocol. To avoid selection bias, only pregnancies recorded before fetal outcome is known and within week 16 of gestation are included in the prospective risk assessment. Data on patient demographics, type of epilepsy, seizure frequency, family history of malformations, drug therapy and other potential risk factors are obtained, and follow-up data are collected once at each trimester, at birth and one year after delivery. Ali data are transferred electronically to the Central EURAP Registry in Milan, Italy. During the 3-year period, we have been following-up 17 pregnancies and are including new ones. The average age of our pregnant women is 27 years and the generalized type of epilepsy has been diagnosed in 10 of them (localization-related in 7). AEDs are used as monotherapy in 15 patients. The most frequently used AEDs in our group are carbamazepine and valproic acid. Folic acid is used in all pregnancies. No specific teratogenic effects have been ob-served. No major birth defects connected with AEDs usage were observed in our group of pregnant women. According to this it is obvious that answers to the unsolved questions in this field, such as real impact of AEDs (teratogenicity) can only be reached through population-oriented pregnancy registries such as EURAP.