Study population and data
EUROmediCAT is a network dedicated to the study of medication safety in
pregnancy which includes EUROCAT population-based CA registries
collecting data on medication exposure during pregnancy. Currently 20
EUROCAT registries from 14 countries participate in EUROmediCAT with
annual surveillance covering approximately 753,000 births per year
throughout Europe (www.euromedicat.eu)32.
The registries collect and send anonymised individual case data to the
EUROmediCAT Central database. The standard data on each registration are
described in EUROCAT Guide 1.4.31 One syndrome and up
to eight malformations are coded using International Classification of
Diseases, Ninth Revision (ICD-9) or Tenth Revision (ICD-10) codes with
British Pediatric Association (BPA)/RCPCH one-digit extensions.
Registrations with only anomalies on the EUROCAT list of minor anomalies
are excluded leaving registrations with one or more major malformations.
This list of minor anomalies includes also anomalies of non-congenital
origin including pyloric stenosis, and Patent Ductus Arteriosus in
preterm births. All registrations are classified to EUROCAT subgroups
according to their ICD9/10-RCPCH codes, as set out in EUROCAT Guide 1.4.1 The sources used to obtain data on CA vary across
registries and include maternity, neonatal, and paediatric records;
fetal medicine, cytogenetic, pathology, and medical genetics records;
paediatric cardiology services; and hospital discharge and child health
records.33 The majority of the registries record
anomalies diagnosed up to at least one year of age.
Medications taken in the first trimester of pregnancy are coded
according to the Anatomic Therapeutic Chemical (ATC) classification.
Maternal disease before and during pregnancy are recorded using ICD
codes. Most registries (84%)
collect prospective data on medication exposure during the first
trimester, mainly from maternity and other medical files, and some
collect retrospective data from interviews with women after delivery or
other sources, either alone (17%) or in combination with prospective
sources (28%)34. All participating registries
reviewed antibiotic exposures to confirm that they were first trimester
exposures.
All registries recording information on antibiotic exposures (regardless
of timing), with data over the period of this study (1995-2012), were
eligible to participate in the study. Eighteen of the 23 (at start of
study) eligible registries agreed to participate in the study and gave
permission for their data to be
extracted.