History and Funding
The Registry started in 1979 in the province of Florence and from 1992 in the whole Tuscany region. The Registry is a surveillance programme included in the Regional Statistics System; it is formally recognised and supported by the Tuscany Region Health Authority. The Registry joined EUROCAT in 1979.
Population Coverage
The programme is population-based I which includes all mothers resident in the Region of Tuscany. It involves all the regional hospitals and the coverage is around 95% of all births in the Tuscany region (approximately 3.5 million inhabitants and 30,000 births per year).
Sources of Ascertainment
Multiple sources are used to ascertain malformed infants; records are obtained from all obstetrical and maternity units, pediatric departments, paediatric cardiology departments, paediatric cardiac surgery units, prenatal diagnostic centres and medical genetics units. Paediatric cardiology centres covering part of the registry population supply systematic case lists and diagnostic details to the registry. Cytogenetic laboratories only confirm karyotype for cases already known. Mothers are interviewed by using a standardised questionnaire. Malformed babies diagnosed within the first year of life are also registered.
Maximum Age at Diagnosis
Up to 1 year of age.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is legal when there is no possibility of autonomous life for the fetus. The Italian law (L.N. 194/78) lays down that termination is allowed in the case of diagnosis of serious fetal pathology which may detrimentally affect the women's physical or psychological health. Induced abortions after prenatal diagnosis of birth defects are systematically included. Data for induced abortions first became available in 1982.
Stillbirth and Early Fetal Deaths
The official definition of stillbirth in this Registry is: 180 gestational days. Fetal deaths of 20 weeks or more gestation are systematically included.
Exposure Data Availability
Maternal and paternal occupation, life-style and socio-economic characteristics are obtained by interviews of mothers of malformed infants.
Denominators and Controls Information
Vital statistics and other epidemiological information are obtained by the Certificate of Delivery Assistance (Certificato di Assistenza al Parto - CAP) collected by the Regional Bureau of Statistics.
Ethics & Consent
The registry does not require ethics committee approval in order to collect and store data. At the moment informed consent is not required by national legislation, but the registry asks for oral authorization from the mother. The parents have to agree to the inclusion of the child on the Register (opt-in).
Address for Further Information
Dr Anna Pierini, Project Leader
Unit of Epidemiology, CNR Institute of Clinical Physiology,
Via Moruzzi 1,
I-56124 Pisa,
Italy
Tel: +39 050 3152102
Fax: +39 050 3152570
Email: apier@ifc.cnr.it