Epilepsy, pregnancy, and major birth anomalies: an Italian prospective, controlled study.

We followed prospectively 97 women with epilepsy during 138 pregnancies and 88 women without epilepsy, matched for age, during 140 pregnancies. We evaluated seizure frequency, pregnancy outcome, and presence of major congenital malformations, and correlated them with the type of epilepsy, antiepileptic drugs (AEDs) implicated, plasma AED levels during pregnancy, and maternal age. We compared the two groups regarding type and number of pregnancies; complications during gestation, labor, and delivery; prevalence of abortions (spontaneous or induced); perinatal deaths; and type and prevalence of major malformations. No change in seizure frequency during pregnancy was seen in 79.7% of cases. Pregnancy complications and incidence of major congenital malformations were only slightly higher in women with epilepsy than in women without epilepsy. No single AED used as monotherapy correlated with increased risk of malformations, but polypharmacy with phenobarbital and phenytoin seemed to represent a risk factor. Low socioeconomic status, older age at delivery, and family history of malformations were other risk factors for neonatal malformations.