History and Funding
The Congenital Anomalies Registry of ATS Val Padana started collecting data for the Mantova province in 2008. In 2021, it extended the surveillance to the Cremona province. The first birth year collected is 2002 for Mantova and 2016 for Cremona.
The registry joined EUROCAT in 2016 and has become full member in 2023.
The registry is located within the Epidemiology Unit of the Agency for Health Protection of ATS Val Padana that also coordinates the Cancer Registry and the Mortality Registry. The main aim of the Registry is to describe the distribution and frequency of congenital anomalies for the population and to assess possible effects of drugs and pollutants. There is no specific funding.
Population Coverage
The registry follows the EUROCAT definition of “population based I”, including all the babies born to all mothers resident in the provinces of Mantova and Cremona (177 municipalities, 755,865 inhabitants), Lombardia region. It accounts for about 5000 births per year.
Sources of Ascertainment
The registry performs an active search for cases starting from the administrative database: hospital discharge records, outpatient tests and visits, birth certificates (CeDAPs), death certificates, pathological anatomy database, drug prescriptions, rare diseases registry and exemptions from copayment. The result of record linkage procedures is a list of potentially malformed cases whose clinical records are reviewed by registry operators. When clinical records are not available, general practitioners are source of information about their patients.
Maximum age at diagnosis
The registry records cases up to the first year of life.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy became legal in Italy in 1978. The Italian law (L.N. 194/78) states that TOPFA is allowed in the case of diagnosis of serious fetal pathology which may detrimentally affect the woman’s physical or psychological health. The upper gestational age limit for terminations is 23 weeks. Cases of congenital anomaly of the fetus among TOPFA are recorded.
Prenatal diagnosis
The most recent legislation on pregnancy (DPCM n. 65, 18 March 2017) details a protocol covering laboratory and diagnostic tests for pregnant women (ultrasound, amniocentesis, chorionic villus sampling AFP/triple test etc.). Cytogenetic testing is provided routinely for women over 35 years of age. After two consecutive abortions or previous pathologies of pregnancy with perinatal death or positive family history of inherited disorders, a genetic counselling with cytogenetic and genetic testing are offered independent of age; these services are free of charge. The Nuchal Translucency plus bi-test (freeBetaHCG e PAPP-A) are offered to all pregnant women within the fourteenth week. Tri test is scheduled by the nineteenth week of pregnancy. The protocol calls for two ultrasound examinations, a third one is added in the third trimester of pregnancy if fetal pathology has been diagnosed.
Stillbirth and Early Fetal Deaths
The official definition of stillbirth in this Registry is 180 gestational days. Fetal deaths of 20 weeks of gestation or more are systematically included (with no lower weight limit exclusion criteria).
Exposure Data Availability
Exposure information can be obtained via record-linkage between different databases or by consulting medical records. Exposures to drugs and radiological examinations are retrievable from the administrative database of drug use and from outpatient or inpatient services. The environmental exposures can be retrieved by georeferencing mothers' residence address and by cross-referencing with pollutant concentration maps. Socio-cultural factors such as immigrant status, parents' educational qualifications and employment position are detectable in health database.
Data collection
The procedure consists of an initial collection of data from health databases carried out by statisticians and data managers. Subsequently, the selection and recovery of medical records is carried out by healthcare personnel, who also deal with the registration of cases of congenital anomalies in the DMS program provided by EUROCAT.
Denominators and Controls Information
Birth statistics are provided by the National Institute of Statistics (ISTAT).
Ethics & Consent
Since surveillance for prevention purposes is part of the mission of the Agency for Health Protection of the Val Padana and the registry is based on cases identified through retrospective analysis of routinely collected data, the registry does not require approval by the local Ethics Committee.
Address for Further Information
Registry staff:
Marco Villa - Registry Leader and Epidemiologist (part time)
Linda Guarda - Data Manager and Statistician Epidemiologist (part time)
Maria Dall’Acqua - Encoder Health Assistant with experience in pathology’s registries (part time)
Marilena Ceresola - Encoder Nurse with experience in Neonatal Pathology (part time)
Erica Giacomazzi - Encoder Nurse with experience in Neonatal Pathology (part time)
Contact details:
Congenital Anomalies Registry of ATS Val Padana, Unit of Epidemiology
Via dei Toscani 1, 46100 Mantova, Italy
Tel +39 0376334643
Email: epidemiologico@ats-valpadana.it
Last updated: 19.07.2023