Databases
A description of databases can be found here.
EUROmediCAT has mainly focused on studies of risk of congenital anomaly, and studies of drug utilisation in pregnancy. However, the EUROmediCAT network now also researches other pregnancy outcomes, and uses a variety of methodological approaches to study medication safety in pregnancy.
The EUROmediCAT Central Database
Population-based congenital anomaly registries contributing their data to the EUROmediCAT Central Database are members of EUROCAT (European Surveillance of Congenital Anomalies). Only EUROCAT member registries which collect medication exposure information participate in EUROmediCAT - currently 19 registries from 14 countries. A description of each member registry is available on the partner page of our website here.
Cases of congenital anomaly include livebirths, stillbirths and fetal deaths from 20 weeks gestation, and terminations of pregnancy for fetal anomaly (of any gestational age). The inclusion of terminations of pregnancy is a vital component of valid population-based congenital anomaly data. Member registries transmit a standard dataset that includes anonymised individual records containing information on the mother and baby, diagnosis, first trimester medication exposures, maternal illness and family history, as described in EUROCAT Guide 1.5. Medication exposure is coded to the WHO Anatomical Therapeutic Chemical (ATC) classification. Medication exposure is usually obtained from medical records created during pregnancy, but some registries use additional sources such as maternal interview, or prescription records, as described on our partner page here.
Registries use common software to transmit data to the central database.
Data are available from 1995, and are transmitted yearly (e.g. all data from 2017 births would be transmitted by October 2019). By the end of 2021, the EUROmediCAT Central Database covered a population of 13.2 million births from 1995-2019, and contained data on 35,931 congenital anomaly cases with one or more medication exposures in the first trimester of pregnancy (excluding vitamins and minerals). Annual surveillance now covers approximately 750,000 births per year throughout Europe.
Total Prevalence rates, Prevalence rates and Livebirth Prevalence rates of all EUROCAT congenital anomaly subgroups in EUROmediCAT registries are available at the EUROCAT website and a summary table can be viewed here.
The EUROmediCAT Central Database is held at Ulster University.
The EUROmediCAT Central Database can be used for signal evaluation and signal detection studies, using a case-control design with malformed controls. No data on non-malformed babies is held centrally, Examples of published studies using this database relating to antiepileptics, SSRIs and antiasthmatics can be found at www.EUROmediCAT.eu/publicationsandpresentations.