History and Funding
The Registry started in 1985 as a research project of the University of Malta. It started as a hospital-based register collecting data regarding congenital anomalies diagnosed in babies born at the main general hospital. It became a member of EUROCAT in 1986. Funding for the research project was stopped in 1995 and in January 1997 the then Department of Health Information resumed the functions of the Registry increasing coverage to all hospitals on the islands making it a national population-based register.
The Registry is now run and funded by the Government Directorate for Health Information and Research. The aim of the registry is to provide accurate epidemiological information regarding the occurrence of congenital anomalies in Malta and Gozo.
Population Coverage
The Registry is population-based 1: covering all resident mothers in Malta and Gozo and presently covers about 4,400 births per year. The number of resident mothers giving birth in a hospital outside the area is considered to be negligible as Malta is an island and population movement is limited. It is unlikely that mothers will go abroad to give birth. It is precisely for this reason that the registry is considered to cover close to 100% of births.
Sources of Ascertainment
Reporting is voluntary. Several new sources of information have been used since 1997 and the Registry has back-dated its information to include these sources of information from 1993. For this reason data since 1993 may be considered most complete and reliable. The Registry now employs active data collection from multiple sources including: delivery, obstetric and paediatric wards, paediatric echo cardiology records, genetic clinics records, National Mortality Register, National Obstetric Information System database, Hospital Activity Analysis database and Rare Disease Register.
Voluntary reporting by doctors is also available. These sources cover the whole population of the Maltese Islands.
Babies with a congenital anomaly may be diagnosed and registered up to 1 year of age. Minor anomalies (as defined by EUROCAT) are not registered unless in combination with other major defects. There is no specific legal requirement for notification of congenital anomalies, however the regulatory framework under which this Register functions is stipulated within Subsidiary Legislation 528.10 issued under the Health Act CAP 528.
Maximum Age at Diagnosis
Up to 1 year of age.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is illegal in Malta.
Stillbirth and Early Fetal Deaths
The official definition of stillbirth is: a baby born with no signs of life at gestational age of 22 weeks or more, or a birth weight equal to or greater than 500g. Stillbirths are registered. All early fetal deaths of 20 weeks gestation and over which have been diagnosed as having a congenital anomaly are included. Autopsy rates for 2021 were 70% in stillbirths and 28% for infant deaths.
Exposure Data Availability
Information regarding maternal disease and exposure to medicinal drugs, smoking, alcohol and drug abuse as well as parental occupation are collected for all malformed infants.
Denominators and Controls Information
Epidemiology background data on all births are available from the National Obstetric Information Systems (NOIS) database and the National Statistics Office (NSO).
Registry Description References
Ethics & Consent
The Superintendant of Public Health, within his legal responsibility, requires that a Malta Congenital Anomalies Register is kept in the interests of Public Health (DH circular 36/09). Ethics approval is needed prior to data being released for individual studies, projects or theses.
Malta became an EU member in 2004 and complies with GDPR requirements. There is no national legislation requiring informed consent in order to register a baby with a congenital anomaly.
Address for Further Information
Dr Miriam Gatt,
Malta Congenital Anomalies Registry,
Directorate for Health Information and Research,
95 Guardamangia Hill,
Guardamangia PTA 1313,
Malta
Tel: +356 25599000
Email: miriam.gatt@gov.mt
Last updated: 01.03.2023