History and Funding
The Congenital Anomalies Registry for the Metropolitan Area of Milan started collecting data in 2015 and it was established in 2016. The first birth year collected is the 2012. The registry joined EUROCAT in 2018. The registry is located within the Epidemiology Unit of the Agency for Health Protection of Milan’s Metropolitan Area that coordinates also the Cancer Registry (28.000 new cancer cases per years) and the Mortality Registry (30.000 deaths per years). There is no specific funding. The main aim of the Registry is to describe the distribution and frequency of congenital anomalies for the population of the metropolitan area of Milan.
Population Coverage
The registration area extends over the provinces of Milan and Lodi (195 municipalities for about 30,000 births per year) located in the Lombardy Region, Italy (81,588 births in 2016; in Italy 473,431). Current available data include 195 municipalities for about 3.5 million inhabitants. The registry follows the EUROCAT definition of population based I which includes all mothers resident in the Metropolitan Area of Milan also recovering the 8% of mothers delivering outside registry area.
Sources of Ascertainment
The registry is part of the Health Information System and uses several health flows to identify the cohort of potentally malformated cases. Hospital discharge records (SDO) were used to identify all records with the specific codes defined by EUROCAT. The results are integrated with birth certificates (CeDAP) seeking cases not present in SDO but with specific malformation codes in CeDAP. The same malformation codes mentioned above and all fetal malformation codes are used for searching SDO with therapeutic pregnancy interruption (TOPFA) and CeDAPs of dead new born. In order to improve the sensitivity of the registry, the TOPFA without malformation codes but with genetic tests perfomed by the woman in the previous 6 months, are included in the cases research. The result of record linkage procedures is a list of potentially malformed cases whose clinical records are viewed by registry operators. Registry consults Mortality Registry for confirmatory or supplementary information about cases.
Maximum Age at Diagnosis
Up to 15 months of life.
Termination of Pregnancy for Fetal Anomaly
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. 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. Two ultrasound examinations are foreseen in the protocol, another is added in the third trimester of pregnancy if fetal pathology has been diagnosed.
Stillbirth and Early Fetal Deaths
The official definition of stillbirth is a baby born with no signs of life after 180 days or more gestation (25+6weeks). Stillbirth certificates for cases of congenital anomalies or data about spontaneous abortions are not included. The autopsy rate in 2015 for stillbirths was 100%.
Exposure Data Availability
Information on maternal drug use, maternal and paternal occupations, illness before and during pregnancy, migrant status are collected. Data regarding maternal drugs is recorded as ATC codes, maternal and paternal disease are recoded using the ICD-IX and occupations by the ISCO work codes.
Denominators and Controls Information
Birth statistics are provided by the National Institute of Statistics and the Births certificates records.
Ethics & Consent
The registry does not require the submission to the Ethics Committee because it is based on a retrospective collection of cases routinely identified by using current electronic healthcare information system of Agency for Health Protection of the Province of Milan.
Registry staff and Address
Dr Carlotta Buzzoni – Registry Leader and Epidemiologist (part time)
Dr Margaret Mascherpa – Medical Epidemiologist (part time)
Antonio Riussi – Data Manager (part time)
Rosalba Distefano – Nurse and administrative support (voluntary)
Address:
Registry of Congenital Anomalies in the Metropolitan Area of Milan c/o Unit of Epidemiology
Via Conca del Naviglio 45, 20123 Milan, Italy
Tel +39 02 8578 2114
Fax +39 02 8578 2128
Email registromalformazioni@ats-milano.it
Last update on 24.04.2024