Study question

Is fetal exposure to different antiepileptic drugs associated with different cognitive outcomes in children?

Study design

Design:

planned interim analysis of a prospective cohort study (Neurodevelopmental Effects of Antiepileptic Drugs [NEAD] study).

Setting:

25 epilepsy centres in the USA and UK.

Participants:

309 children, including 6 twins, whose mothers had epilepsy and were taking carbamazepine (n = 93), lamotrigine (n = 100), phenytoin (n = 55), or valproate (n = 61) as monotherapy during pregnancy. Exclusion criteria included maternal IQ scores <70, positive serological tests for syphilis or HIV, progressive cerebral disease, other major disease, exposure to teratogenic agents other than antiepileptic drugs, poor adherence to antiepileptic drugs, or drug abuse in the past year or its sequelae. 258 children (of 252 mothers) were assessed at 2–3 years of age; 309 were included in the …