Progress Report: Australian Register Of Pregnancies 1999-2007
Since 1999 the Australian Pregnancy Register, affiliated with EURAP, has pioneered the use of untreated controls, prospective and retrospective data, AED dose-relationships to malformation risks and drug efficacy.
Under Ethics Committee supervision, informed consenting treated and untreated WWE and those receiving AEDs for other conditions are enrolled. Four telephone interviews are conducted. Factors related to medical, family, epilepsy and drug related histories are recorded. Outcomes are based on the Victorian Birth Register Classification of defects. Analyses are carried out by statistical methods.
To December 2006, the Register contained data on 1002 pregnancies, 992 with known outcomes, 83 not exposed to AEDs in first trimester, and 30 not prescribed AEDs for epilepsy. Statistically significant findings in WWE included more frequent folate supplementation, decreased alcohol intake during pregnancy, a dose-related increased risk of foetal malformation associated with valproate therapy, and a tendency towards lower birth weights in live-born malformed offspring.
Pregnancy had little influence on AED-treated epileptic disorders. Seizures during pregnancy occurred in 49.7% of 841 AED-treated pregnancies in WWE. Epilepsies active before pregnancy, and seizures in pregnancy predisposed to intra-partum and post-partum seizures. The risk of seizures during pregnancy was 50-70% less if the pre-pregnancy year was seizure free. The risk of seizures during labour was small.
Discussion. After one year’s seizure freedom there seemed little advantage in deferring pregnancy to avoid seizures returning whilst pregnant. Collaborative Registers are essential to establish a database for studying drugs in monotherapy, for future studies on birth defects, cognitive outcomes and for pharmacogenetic
advances.