History and Funding
The Congenital Anomalies Registry of Aragón (ARACA) started a pilot study in a General Hospital in 2019. In January 2022, we became Affiliate Member and start expanding our registry to the entire region. We also plan to introduce retrospective data. The registry is funded by the Regional Health Authority (Departamento de Sanidad).
Population Coverage
The aim of our registry is Population-based I (All mothers resident in a defined geographic area). Geographical scope is Aragon Region (Comunidad Autónoma de Aragón), about 1 300 000 inhabitants and 47 720.25 km² extension. The annual numbers of births are 9 095 (2020 data), which represents about 2.65 % of births in the country (Spain).
Sources of Ascertainment
This registry is voluntary (i.e. not compulsory by law) however, our aim is that any severe malformation will be registered. All TOPFA are registered by law.
Cases will be notified by the clinician who diagnoses anomaly in the Departments of Hospitals of the Region implied in treatment and diagnosis of Congenital Anomalies.
Maximum Age at Diagnosis
The maximum age at diagnosis of livebirths for inclusion on the register is one year, but, at present, Neurology and Cardiology Departments make follow up to 14 years.
Termination of Pregnancy for Fetal Anomaly (TOPFA)
Since the year 2010 is the termination of pregnancy for fetal anomaly is legal in Spain. In cases of a fetal anomaly is termination legal within 22+6 weeks when severe anomalies occurred. There is no limit when life after birth is incompatible or extremely severe after an expert committee decision. All TOPFA are registered and communicated to INE (National Institute of Statistics).
Prenatal Diagnosis
Prenatal screening and diagnosis are offered to all mothers and covered by the Public Health, including immigrants without legal residence in Spain.
Stillbirth Definition and Early Fetal Deaths
In Spain, stillbirth definition is 22 weeks and above or more than 500g. All TOPFA regardless of gestational age is recorded. We obtain every autopsy record of congenital anomaly (when done) as well as stillbirth certificates for these cases before hospital discharge because it is in an official compulsory registry.
Exposure Data Availability
Information on maternal drug use, maternal and parental diseases is available, as well as the outcome of previous pregnancies and assisted conception.
Data collection
Statistics are provided by INE (National Institute of Statistics) and IAEST (Regional Institute of Statistics), as well as RAE-CMBD (Registro de Actividad Hospitalaria-Conjunto Minimo Básico de Datos de altas hospitalarias) for clinical data, HCE (Electronic Medical History) and IVE Register for abortions.
Denominators and Controls Information
Information on birth statistics come from RAE-CMBD. Data of births can be obtained by maternal age group monthly. No information about controls is collected.
Ethics & Consent
A specific legal regulation will be implemented so no specific informed consent will be necessary, however for prospective investigations projects, informed consent will be required and previous authorisation of CEICA (Aragon Ethical Committee for Investigation).
Address for Further Information
Javier Moll Lecha
Federico Arribas Monzón
Registro de Anomalías Congénitas
Dirección General de Asistencia Sanitaria
Departamento de Sanidad
Gobierno de Aragón
Vía Universitas 36
50017 Zaragoza
Spain
Tel: +34 976 715845 or +34 976 714306
Email: jmoll@aragon.es
farribas@aragon.es
Updated: 16.2.2023