The Australian Register of Antiepileptic Drugs in Pregnancy (APR) was set up in 1998 to collect data concerning the hazard of foetal malformation from intrauterine exposure to antiepileptic drugs in Australian women with epilepsy who were enrolled during pregnancy and could be followed for a year after childbirth. By December 2017, the APR held records of 1879 such pregnancies, a cohort that was followed prospectively. At the end of pregnancy, there had been 1766 live births (94.0%), 5 stillbirths (0.3%), 54 spontaneous abortions (2.9%), and 30 induced abortions (1.6%), while 24 pregnancies had an unknown outcome due to loss of contact with the women involved (1.3%). Foetal malformations had occurred in 71 of the live-born infants. Of the induced abortions, 15 had been due to intrauterine foetal death, 10 due to major foetal malformation (spina bifida, anencephaly and left heart underdevelopment), 2 due to detected chromosome defects and 3 due to maternal reasons (major illness in 2). By the end of the post-pregnancy year a further 99 pregnancies had become unavailable for follow-up (resulting in an 84.9% live-born infant final retention rate). An additional 33 pregnancies that had resulted in late-recognised foetal malformations had been identified, nearly all in the first 6 months after birth. Intrauterine valproate exposure was involved in 447 of the 1731 antiepileptic drug-treated pregnancies, i.e. a malformation-carrying pregnancy rate of 11.86%, as compared with a rate of 2.70% in the 148 drug-unexposed pregnancies (O.R. = 4.84; 95% C.I. 1.72, 13.62). The investigation of the cohort seemed to confirm previous interpretations of the APR data, but also provided insights into the pregnancies of women with epilepsy that for various reasons did not result in live-born offspring.
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