History and Funding

Registration of congenital anomalies in the Basque Country started on 1 January 1990. The Registry became a EUROCAT member in September 1990. The Registry is financially supported by the Health Department of the Basque Government.

Population Coverage

The Registry is located in the Basque Country region, in northern Spain, covering a geographic area of 7,260 km2 and a population of 2,180.449 inhabitants. It is a population based registry which therefore includes all mothers delivering in the Basque Country excluding any non-residents. The average number of annual births 2013-2017 is 18,606. It is estimated that 1-2% of outside resident mothers deliver in the covered hospitals.

Sources of Ascertainment

Reporting is voluntary, although the capture of data is now systematic for 80% of cases using the automated hospital database. There is an active search for cases (livebirths, stillbirths and induced abortions), through multiple sources of information: Hospital discharge records, Hospital automated data, Neonatal Units, Specialist Paediatric Department, Cytogenetics and Pathology laboratories and private maternity hospitals.

Paediatric cardiology centres supply diagnostic confirmation when requested by the registry for specific cases.

We do not have direct access to cytogenetic labs. We ask for the results personally from the geneticists at each of the hospitals involved in the registry. Usually labs supply the list of prenatal and infant abnormal karyotypes when requested.

Maximum Age at Diagnosis

Routinely reported to the Registry up to 1 year of age.

Terminations of Pregnancy for Fetal Anomaly (TOPFA)

Since March 2010 “Sexual and reproductive health and abortion” in Spain is governed by a new law. The upper gestational age limit for TOPFA depends on the seriousness of the condition: 1. Up to 22 weeks, if there is risk of serious fetal anomalies (a previous clinical report from other two specialists is required). 2. Unlimited, if fetal anomalies incompatible with life are detected (a previous clinical report from another specialist is required), or an extremely serious and incurable (at the moment of diagnosis) disease is detected (confirmation from a clinical committee is required). Data about techniques of prenatal screening and diagnosis are systematically collected.

Stillbirth and Early Fetal Deaths

The official definition of stillbirth in the Basque Country and Spain too, is: a gestational age of 22 weeks or a birth weight of 500G. Post-mortem examination rates are highly variable in the region. About 90% of autopsies in stillbirths and neonatal deaths were performed in the public maternity hospitals (the remaining 10% of parents did not give permission). The autopsy rate following TOP is high (70%), but the quality varies, depending on hospitals.

Exposure Data Availability

Information on maternal drug use, maternal and paternal diseases, outcome of previous pregnancies and assisted conception is available.

Denominators and Controls Information

Statistics are provided by the Basque Statistics Institute (EUSTAT).

Ethics & Consent

No ethics committee approval required to operate registry. No approval needed for studies that require identifiable patient data. The hospitals have an ethics committee if further ethical recommendations are considered necessary.

Legislation complies with EC95/46 Directive with respect to disease registers and surveillance since 1999. There is not national legislation requiring informed consent to register a baby with a congenital anomaly.

Address for Further Information

Maria del Henar Sampedro Garcia, BSBIO
Congenital Anomalies Registry (RACAV)
Ministry of Health of the Basque Government; Directorate for Healthcare Planning, Organisation and Evaluation
Donostia -San Sebastián 1
01010, Vitoria-Gasteiz
Spain

Tel: +34 945 019280
Email: registros-epidemiologicos@euskadi.eus

 

Last updated: 20.09.2023