History and Funding
The Congenital Anomalies Registry of Comunitat Valenciana started a pilot study of feasibility of establishing a population‐based registry in 2010. Data were collected retrospectively since 2007. The registry is included in the Valencian Rare Diseases Information System (SIER) and it is funded by the Regional Health Authority (Conselleria de Sanitat).
Population Coverage
The registry covers the whole Valencian Region (Comunitat Valenciana). All major congenital anomalies are registered that occur in pregnancies of mothers residing in this region of Spain. The population of the current area is approximately 5 million. The annual number of births for the registry area is about 40.000. Minor anomalies are excluded according to EUROCAT criteria.
Sources of Ascertainment
Reporting is compulsory (Act published in the Official Bulletin) and multi‐source. The main information sources for case identification are:
- Public and private hospital discharges records.
- Perinatal Mortality Registry of Comunitat Valenciana.
- Induced Abortion Registry of Comunitat Valenciana.
Complementary information is obtained from Metabolic Disorder Registry and clinical records are reviewed for the majority of cases obtained from hospital discharge register.
Maximum Age at Diagnosis
Up to 1 year.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is legal. 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). All terminations of pregnancy regardless of the gestational age at termination are registered.
Stillbirth and Early Fetal Deaths
Stillbirths of 22 weeks after the last menstrual period or more are registered. Early fetal deaths/spontaneous abortions are registered and included when the gestational age is 16 weeks.
Exposure Data Availability
Information on maternal drug use, maternal and paternal diseases and occupations, outcome of previous pregnancies, is collected from the clinical records.
Denominators and Controls Information
Background data on births are available from the Metabolic Disorder Registry (population based birth registry). The data of the National Statistics Institute (INE) are used too.
Ethics & Consent
By law, no Ethics Committee approval required to operate a registry. The registry does not require patient/parent explicit consent for case registration. Ethics Committee approval is required for studies that require identifiable patient data.
Address for Further Information
Clara Cavero Carbonell, Registry Leader
Email: cavero_cla@gva.es
Congenital Anomalies population-based Registry of the Valencian Region
Unidad Mixta de Investigación en Enfermedades Raras
FISABIO-UVEG
Avda. Cataluña, 21
46020 Valencia
Spain
Tel: +34 96 1 925724
Fax: +34 96 1 925703
Last updated: 03.03.2023