History and Funding
Registration for EUROCAT network started in Children’s University Hospital Zagreb in 1983 after the preliminary favourable results of the pilot project of congenital anomaly investigation started a year before. Collection and transmission of data was on voluntary basis until 2000. After year 2000, congenital anomaly registration is funded within scientific project dedicated to epidemiological surveillance of congenital anomalies, supported by Ministry of Science, Education and Sports of the Republic of Croatia.
The registry is population based (Population – based I = All mothers resident in defined geographic area). The registry covers North‐western Croatia – two regions at the seaside (Pula, Rijeka) and two continental provinces (Varaždin, Koprivnica and Vinkovci). Births take place in four regional hospitals with practically no homebirths (only by accident). In 2009 we have included in our registry a delivery unit Vinkovci, covering additional 1284 births. Total number of monitored births Croatia in 2009 was 9181, reaching the population coverage of 20.8% births.
Sources of Ascertainment
In four maternity units: Varaždin, Koprivnica, Rijeka and Pula neonatologists and gynecologists record cases with congenital anomalies among livebirths, stillbirths and terminations of pregnancies. Birth and stillbirth certificates include notification of congenital anomalies and are used as additional source of information as well as hospital discharge lists.
Part of population (local registry Rijeka) is covered by paediatric cardiology center diagnostic. Children born in this neonatal unit have the cardiac ultrasound newborn screening. Paediatric cardiology center doesn't supply case list with details and diagnostic details to the registry. In other local registries there is no paediatric cardiology centers but children suspected of having cardiac defect are referred to paediatric cardiologist for estimation. Cardiac ultrasound and diagnosis are made by paediatric cardiologist. Data about patients with congenital heart defects are then collected by neonatologist employed in neonatal units and referred to the registry.
Zagreb registry at present does not have direct access to cytogenetic labs from local registries. In local registries personnel gets data from cytogenetic and molecular laboratories and in case of death from post-mortem examination.
Maximum Age at Diagnosis
Maximum age at diagnosis is up to one year.
Terminations of Pregnancy for Fetal Anomaly (TOPFA)
Termination of pregnancy is regulated by Croatian law in 1978 (NN/18/78). Upper limit for termination of pregnancy for serious foetal anomaly is 22 gestational weeks.
Stillbirth and Early Fetal Deaths
Official stillbirth definition in Croatia is 22 completed gestational weeks/500g weight. Registry collects data about stillbirths, and foetal deaths/ spontaneous abortions from 20 weeks. The local registries also record results of autopsy of all termination of pregnancies following prenatal diagnosis, stillbirths and early neonatal deaths (0-7days). Autopsy rates in these cases are generally high, around 90-100%.
Exposure Data Availability
Exposure information includes: data on parental occupation, maternal drug use, maternal smoking and alcohol abuse, maternal diseases before and during pregnancy. Data about techniques of prenatal screening (ultrasound, serum markers) and assisted reproduction methods are collected as well and are available for most of the recorded cases.
Information on annual births and maternal age distribution is obtained from the population databases and statistical units of the local authorities.
Ethics & Consent
In order to collect and store data the registry requires ethics committee approval from Ethics Committee of the Children's University Hospital Zagreb and Ethics Committee of Medical School University of Zagreb. Approval is renewed every 5 years.
National legislation will probably require informed consent in order to register a baby with a congenital anomaly in the near future. At present the registry collects data as hospital statistics needed for public health planning and for this we don't need informed consent for each case.
There is possibility of case identification at local level in order to avoid duplicate registration, to allow updating of information or diagnosis, and to assist children and their families in future. Zagreb Registry sends to Central Registry anonymous computerised data with local serial number for each case for the use in communication with the local registries. Safety measures are established to prevent unauthorized use of the records.
Address for Further Information
Ljubica Odak, MD PhD
Department of Medical Genetics and Reproductive Health
Referral Centre of the Ministry of Health for Surveillance of Congenital Anomalies
Children's Hospital Zagreb,
Klaiceva 16, 10-000 Zagreb
Tel: +385 1 4600250
Lat update: 03.03.2023