History and Funding
The national Malformation Register was established in 1963 and regular monitoring started in 1977. In 1974 the Registry became a full member of ICBDSR and in 1998 it became an associate member of EUROCAT. It is run and financed by THL, the governmental National Institute for Health and Welfare (under the Ministry of Social Affairs and Health). THL collects data on congenital anomalies and maintains the Register of Congenital Malformations pursuant to the Act on the National Institute for Health and Welfare (668/2008).
Population Coverage
The Registry is national and population-based I: all mothers resident in defined geographic area. All births in Finland are covered, representing approximately 45 000 births annually. Selective terminations of pregnancy due to congenital anomalies have been included since 1993.
Sources of Ascertainment
Notification to the Registry is compulsory. The Register of Congenital Malformations receives data on congenital anomalies from hospitals, health care professionals and genetic laboratories. It also draws data from the Medical Birth Register, the Care Register for Health Care (Hospital Discharge Register), the Register on Induced Abortions, all maintained by THL, and from the National Supervisory Authority for Welfare and Health (Valvira), as well as from the Cause of Death Statistics, maintained by Statistics Finland. When necessary, the diagnoses obtained from these data sources are confirmed by contacting the hospital or health care unit that have given treatment to the infant/fetus/woman. Information on malformations is principally collected up to 1 year of age, but later information is also included.
Aggregated data are transmitted to ICBDSR and EUROCAT.
Maximum Age at Diagnosis
Up to 1 year of age for surveillance purposes, but later diagnoses are also registered.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is legal and on request until 12+0 weeks. Termination of pregnancy for fetal reasons (severe congenital anomaly, other birth defect or disease) can only be granted by a special permission from the National Supervisory Authority for Welfare and Health (Valvira). At the gestational age of from >20+0 up to ≤24+0 weeks, termination of pregnancy can only be granted by Valvira's permission when a severe fetal malformation or disease has been detected by reliable prenatal diagnostics.
Stillbirth and Early Fetal Deaths
Prior to 1987, stillbirths of 28 weeks or more were registered. At present, stillbirths of at least 22 weeks of gestation (≥22+0) or 500g of birth weight (≥500g) are registered.
Denominators and Controls Information
Epidemiological background data are available on all births in the Medical Birth Register and in Statistics Finland.
Registry Description References
More information on the Registry can be found in the THL website in English:
https://thl.fi/en/web/thlfi-en/statistics-and-data/data-and-services/quality-and-statistical-principles/quality-descriptions/congenital-anomalies
Ethics & Consent
According to the law on the nationwide person data health registers and the Person Data Act, no informed consent is needed for collection of identifiable case data into the national health care registers (these registerAccording to the Act on the National Institute for Health and Welfare (668/2008), no informed consent is needed for collection of identifiable case data into the national health care registers (these registers are specified by the law and statute). Thus, no informed consent is required in order to register a pregnancy or newborn with a congenital anomaly into the Registry. It is not allowed for the Registry to contact the registered persons or their families. Because of the legislation ethics committee approval in order to collect and store data in the national health care registers is neither required. It is obligatory for the health care personnel to notify the malformed cases.
It is possible to get permission to use the individual-level data in the national health care registers for scientific studies with a specific permission from the Social and Health Data Permit Authority, Findata.
Address for Further Information
Sonja Kiuru-Kuhlefelt, Registry Leader
THL, Finnish Institute for Health and Welfare,
P.O. Box 30, FI-00271 Helsinki, Finland
Tel: +358 20 610 7376
Email: sonja.kiuru-kuhlefelt@thl.fi
Website: http://www.thl.fi
Last updated: 18.04.2023