Birth Outcomes in Pregnant Women with Epilepsy: a Nationwide Multicenter Study from Türkiye.

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The present study was aimed at investigating the effects of anti-seizure medications (ASMs), patient demographic characteristics, and the seizure type and frequency on the development of congenital malformation (CM) in infants of pregnant women with epilepsy (PWWE). PWWE followed-up at the neurology outpatient clinic of 21 centers between 2014 and 2019 were included in this prospective study. The follow-up of PWWE was conducted using structured, general pregnant follow-up forms prepared by the Pregnancy and Epilepsy Study Committee. The newborns were examined by a neonatologist at 1. and 3. months postpartum. Of the infants of 759 PWWE , 7.2% had CMs, with 5.6% having major CMs. Polytherapy, monotherapy, and no medications were received by 145 (19.1%), 517 (68.1%), and 42 patients, respectively. CMs were detected at an incidence of 2.3% in infants of those who did not receive medication, 5.7% in infants of those who received monotherapy, and 13.7% in infants of those who received polytherapy. The risk of malformation was 2.31-folds (95% confidence interval: 1.48-4.61, p < 0.001) higher in infants of PWWE who received polytherapy. Levetiracetam was the most frequently used seizure medication as monotherapy, with the highest incidence of CMs occurring with valproic acid (VPA) use (8.5%) and the lowest with lamotrigine use (2.1%). The incidence of CMs was 5% at a carbamazepine dose <700 mg, 10% at a carbamazepine dose ≥700 mg, 5.5% at a VPA dose <750 mg, and 14.8% at a VPA dose ≥750 mg. Thus, the risk of malformation increased 2.33 times ( p = 0.041) in infants of those receiving high-dose ASMs. Birth outcomes of PWWE receiving and not receiving ASMs were evaluated. The risk of CMs occurrence was higher, particularly in infants of PWWE using VPA and receiving polytherapy. The incidence of CMs was found to be lower in infants of PWWE receiving lamotrigine.