History and Funding
The Registry started in 1964 as a trial and was established in 1965. In 2003 the Registry became an associate member of EUROCAT. The Registry system (data collection etc) was changed in 1999. Specific laws and statutes on national health care registers, which hold personal data, regulate the activities of the Registry. It is run and financed by the National Board of Health and Welfare, the governmental National Research and Development Centre for Health and Welfare (under the Ministry of Social Affairs and Health).
Population Coverage
The Registry is national and population based I: All mothers resident in a defined geographic area. All births in Sweden are covered, representing approximately 100,000 births annually. Selective terminations of fetuses with malformations are included since 1999.
Sources of Ascertainment
From 1999, the register does not receive notifications from paediatric cardiology centres. However, information from detailed cardiovascular examinations could be attached to the reports sent by the reporting unit (pediatric or obstetric department).
Notification to the registry is compulsory. Reports are obtained from departments of pediatrics, obstetrics, clinical genetics, and cytogenetic laboratories. The diagnoses of the malformed cases are often received from more than one source. Paediatric cardiology centres do not supply information to the registry, but other sources of information cover paediatric cardiac surgery. The cytogenetic information is obtained through annual reports from all cytogenetic laboratories in the country, and contains information on all prenatal and infant abnormal karyotypes.
Aggregated data are transmitted to EUROCAT.
Maximum Age at Diagnosis
Information on malformations is principally reported before one month of age except for congenital heart malformations, which are reported up to 1 year of age.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is legal. Termination of pregnancy for fetal reasons (congenital anomaly) can be granted after special permission after 18 weeks and up to 23 weeks of gestation from an ethical committee at the National Board of Health and Welfare.
Stillbirth and Early Fetal Deaths
The definition of stillbirths in Sweden is birth after 22 weeks of gestation. Since 1999 all fetal deaths with congenital malformations greater than 22 weeks of gestation are registered at the Swedish Registry of Congenital Malformations.
Exposure Data Availability
Exposure information on all births is available in the Medical Birth Register since 1973.
Denominators and Controls Information
Epidemiological background data are available on all births in the Medical Birth Register and in the Statistics of Sweden.
Ethics & Consent
The registry does not require ethics committee approval in order to collect and store data. The Register is ruled under a special law for the registers of health care run by the Swedish National Board of Health and Welfare. For investigations run by other groups of researchers than those working within the Swedish National Board of Health and Welfare, approval from ethics committee is compulsory.
National legislation does not require informed consent in order to register a baby with a congenital anomaly.
Address for Further Information
Dr Karin Källén, the Swedish National Board of Health and Welfare,
and Dep. of Reproduction Epidemiology,
Institution of Clinical Sciences,
University of Lund,
Sweden.
Tel: +46 46 222 7538
Fax:
Email: karin.kallen@med.lu.se