History and Funding
The Registry started its activities in 1978 with the participation of a few collaborating centres rising to cover all delivery units in the Region.
Since 1980 the Registry is recognised and supported by the Emilia Romagna Region with the following objectives:
- to produce prevalence data on congenital malformations
- to provide temporal and spatial surveillance and management for alarms
- to conduct studies to evaluate health interventions (pre-natal and neonatal screening)
- to provide a reference centre, both clinical and epidemiological, for congenital malformations.
The Registry joined EUROCAT in 1980 and in 1981 transmitted the first birth year of data to EUROCAT. The Registry joined the International Clearinghouse for Birth Defects in 1995. The Emilia Romagna Registry also participates in the co-ordination of the Italian Congenital Malformation Registries set up by The Italian National Institute for Health (l'Istituto Superiore di Sanità) with the aim of sharing the experiences of the various registries, create common lines of research and produce epidemiological data on congenital malformations at a national level (http://www.iss.it). The Registry created a website in 2000, which has since been expanded and developed. www.registroimer.it
Since 2003 the Registry has been in collaboration with the Health Information systems service and Social policy body of the Emilia Romagna Region formally involved in the Scientific Steering Committee.
In 2004 a link with the Regional Medical Genetics Service network was formed (www.geneter.it) with the aim of providing genetic counselling and evaluating genetic conditions diagnosed within the network and in the same year with the Regional birth assistance database Cedap (Certificate of Assistance at delivery). From 2004 additional information on maternal medication is available from the Regional Prescription Database.
From 2005, the Registry has progressively moved away from paper data collection developing an integrated system of ascertainment based on linking regional healthcare databases and specific competence in database management. An algorithm has now been developed to integrate and validate cases.
From 2009 the IMER Registry ascertains cases for the 1st year of life.
The exchange of data between IMER and the registry of rare diseases allows better identification of recognized conditions in IMER. The collaboration that has been established has resulted, for example, in a contribution to the Annual Report on Rare Diseases from IMER and a chapter on Rare Diseases in the IMER Annual Report so maximising dissemination and providing a unique source of information for decision making.
Every year the Registry provides a scientific convention, course for reference centres, and an annual report.
Population Coverage
The Emilia–Romagna region covers an area of 22,123 sq.kms with a population of around 4,464,119 people (2020 Istat). The total number of births in Emilia Romagna has fallen in recent years with 30,321 births in 2020.
The registry follows the EUROCAT definition of population based II (includes all mothers delivering within the region of Emilia Romagna, irrespective of place of residence). In 2020, 92.7% of births were to resident mothers.
Since 2006 the registry, in collaboration with the Regional births database (CeDAP) has reached a population coverage of about 100% involving all 22 delivery units in the Region. In recent years immigration has created an important demographic change. The births to non-Italian citizens represented 32.3% of the total births in the region in 2020.
Sources of Ascertainment
Emilia Romagna Registry has the following multiple sources of ascertainment:
- Voluntary hospital participation. From 2011 reporting is on line using the IMER website. Data entry is password controlled with cases being entered by neonatologists, paediatricians and obstetricians during the first year of the infant's life. Paediatric cardiology centres supply diagnostic confirmation when requested by the registry for specific cases.
- The Regional Births database (CeDAP). This also provides the registry with a source of denominator and control data.
- The hospital discharge database (SDO) provides a further source of ascertainment up to one year of life. An algorithm has been developed to identify and validate malformed cases according to the EUROCAT guidelines. Suspected cases are referred to the IMER reference person at the birth centre for confirmation.
- The Regional TOPFA database provides minimal data on TOPFA which reference centre clinicians integrate where possible.
- Rare Disease Registry this provides about 1% of cases but these are complex recognised conditions and this source ensures a full description of the final diagnosis.
- Cytogenetics - from 2012 data cytogenetic test results and karyotypes where available will be provided to EUROCAT.
- Mortality database. The database is used to record deaths that occur in the 1st year of life.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy became legal in Italy in 1978. Data for TOPFA first became available in 1982. 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 2 weeks. TOPFA after prenatal diagnosis of birth defects are systematically included in IMER but data access is a current issue.
A ministerial decree (decreto 10.09.1998 GU no.245 del 20.10.98) detailed a protocol covering laboratory and diagnostic tests for pregnant women (ultrasound, amniocentesis, chorionic villus sampling AFP/triple test etc.). Three ultrasound examinations at 10, 20 and 30 weeks gestation were foreseen in the protocol. Since 2017, cytogenetic testing and the 30 weeks ultrasound are no more provided routinely. After Genetic Counselling in high risk setting, cytogenetic and genetic testing are offered independent of age; these services are free of charge. In the Emilia Romagna Region, non-invasive prenatal test for screening of trisomies (NIPT) 13-18-21 is free of charges from 2019.
Stillbirth and Early Fetal Deaths
The official definition of stillbirth in this Registry is now 180 gestational days in line with the Regional Births database (CeDAP). Fetal deaths of 20 weeks or more gestation are systematically included (with no lower weight limit exclusion criteria). The autopsy rate in in stillbirth (n=92) in 2020 was 99 % overall.
Exposure Data Availability
From 2003 data regarding maternal drugs in the first trimester is recorded as ATC codes were the case is identified by a participating centre. and jobs are recorded using the ISCO work codes. IMER Registry is participating in the EUROmediCAT and holds data on maternal prescriptions from 2004 onwards. Access to the regional prescription database allows specific linkage studies to be conducted.
Denominators and Controls Information
Birth statistics are provided by the Regional births database (CeDAP) recorded by maternal age group and birth month. This source also provides information for control cases. General demographic information is available for all births in the area (e.g. mean maternal and paternal ages, percentage of mothers 35 years or older). In recent years immigration has created an important demographic change and births to non-Italian citizens represented 32.3% of the total births in the Region in 2021 The citizenship of the mother is coded for all births.
Further information regarding the reference population can be gained from the Emilia-Romagna region website http://www.regione.emilia-romagna.it/index.htm
Ethics & Consent
The registry is recognised as part of the Health system information flow and regulated by Regional Laws.
Address for Further Information
Registry staff and computing:
Dr. Amanda J Neville - EUROCAT Registry Leader
Dr Marco Manfrini - Epidemiology and database management
Dr Elisa Ballardini - Neonatologist and researcher
IMER Registry (Emila Romagna Registry of Birth Defects),
Center for Clinical and Epidemiological Research, University of Ferrara Azienda Ospedaliero - Universitaria di Ferrara
Corso Giovecca, 203
44121 Ferrara,
Italy
Tel. 00 39 0532 237384
Email: imer@unife.it
Website: www.registroimer.it
Last updated: 18.04.2023