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We undertook a population-based study to assess the comparative risk of spontaneous abortions, terminations of pregnancy (TOPs), major birth defects (MBDs), preterm births and small for gestational age (SGA) infants following intrauterine antiepileptic drug (AED) exposure in the Emilia Romagna region, Northern Italy (4 million inhabitants) over a 3-year period (2009–2011). The study was approved by the Local Ethical Committee and authorised by the Hospital Management Executive.
Data were obtained from official regional registries: Certificates of Delivery Assistance (CedAP) for deliveries (>99% coverage of live births and stillbirths) and Hospital Discharge Cards collecting the International Classification of Diseases (ICD) codes of all the discharge diagnoses, for abortions . AED exposure was based on reimbursed prescription databases as AEDs are supplied and reimbursed by medical prescription in Italy; all drugs registered as AEDs and redeemed with ATC code N03 were considered. MBDs were taken from the Registry of Congenital Malformations (IMER) recording MBDs detected by paediatricians in stillbirths and in live births during the first week of the infant's life (coverage >95% of births). Each recording from the first three registries contains a unique anonymous code identifying each citizen and linking information among registries. Recordings from the IMER are routinely linked to the CeDAP and consequently to the others, using an additional procedure (correct linkage >98% of the sample). All data were anonymised at the regional source of data to protect patient privacy according to Italian legislation. For the deliveries cohort, the exposure period was based on the date of delivery and gestational age. For the …
Contributors BM coordinated the collection and analysis of data and drafted the work; EP gave substantial contribution to the interpretation of possible shared mechanisms of fetal damage of the two substances; GC analysed data on fetal adverse outcomes; RD'A monitored the study method and statistical analysis; PT coordinated the Study Group. All the five authors contributed to the conception and design of the main study, accurately revised the text of the letter and approved it.
Funding This study is part of a project funded by the Italian Ministry of Health-Research Program RF 2010-2315893.
Competing interests None declared.
Ethics approval Local Ethics Committee (21/2/2013) and Hospital Management Executive (determination 464, 13/3/2013)
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators ESPEA Study Group members: Gabriele Accetta1, Gianni Astolfi2, Sergio Battaglia3, Francesca Bisulli1,4, Guido Cocchi5, Letizia Conti5, Alessandra Curti6, Roberto D’Alessandro1, Camilla Lupi3, Barbara Mostacci1, Ilaria Naldi7, Carlo Piccinni7, Elisabetta Poluzzi7, Nicola Rizzo6, Giuliana Simonazzi6, Paolo Tinuper1,4, Corrado Zenesini1. 1IRCCS Institute of Neurological Sciences of Bologna, Bologna, Italy; 2Registro IMER, AziendaOspedaliero-Universitaria di Ferrara, Ferrara, Italy; 3Regione Emilia Romagna SISePS, Italy; 4Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy; 5Department of Medical and Surgical Sciences DIMEC, Division of Prenatal Medicine, St. Orsola Malpighi Hospital, University of Bologna, Bologna, Italy; 6Department of Maternal and Paediatric Sciences, Neonatology, St. Orsola- Malpighi Hospital, University of Bologna, Bologna, Italy; 7Department of Medical and Surgical Sciences DIMEC, University of Bologna, Bologna, Italy.
Correction notice Since this letter was first published online Paolo Tinuper's affiliations have been updated so that he is also affiliated with the first institution.