Study identification

EU PAS number

EUPAS2221

Study ID

2222

Official title and acronym

EUROmediCAT: Safety of Medication Use in Pregnancy in Relation to Risk of Congenital Malformations

DARWIN EU® study

No

Study countries

Belgium
Denmark
France
Ireland
Italy
Malta
Netherlands
Norway
Poland
Switzerland
United Kingdom

Study description

A variety of complementary approaches are needed to evaluate safety of medicine use in pregnancy. To evaluate safety in relation to teratogenicity (capacity to cause malformations), population-based congenital anomalies registers, which are already networked across Europe (EUROCAT) with a common database, can provide a cost-effective mechanism which is as yet underexploited. The enormous population coverage of registers when combined gives sufficient statistical power for the identification of associations between specific drugs and specific malformations. This project will develop and test an efficient pharmaco-vigilance system for safety of drugs during pregnancy in relation to teratogenicity by (i) enhancing the information regarding drug exposure in the EUROCAT database, covering a total population of 6 million births 1995-2010, through linkage to electronic databases containing prescription information, and by linkage to chronic disease cohorts (ii) analysing the enhanced EUROCAT database in relation to four drug groups of public health concern – new antiepileptics, insulin analogs, SSRI antidepressants, and antiasthmatics – exposure to all of which is increasing in the pregnancy population (iii) interrogating health care databases to monitor the effectiveness of drug safety recommendations and pregnancy prevention programmes through drug utilisation studies, and to provide an exposure profile for pregnant women (iv) conducting a scoping study of the implications for drug safety of growing internet use by pregnant women, in terms of access to safety information about teratogenicity, and access to drugs with teratogenic potential.

Study status

Ongoing
Research institutions and networks

Institutions

Ulster University
United Kingdom (Northern Ireland)
First published:
20/03/2024
Institution Educational Institution
University of Groningen (RUG) Netherlands, The Academisch Ziekenhuis Groningen/University Medical Center Groningen Netherlands, Paediatric Department, Hospital Lillebaelt - Kolding Denmark, The Poznan University of Medical Sciences (PUMS) Poland, Institute of Clinical Physiology - National Research Council (IFC-CNR) Italy, Swansea University /Abertawe Bromorgannwg University Health Board UK, Queen Mary University of London UK, Provinciaal Instituut voor Hygiene, Antwerp Belgium, Department of Public Health, Cork Ireland, Department of Health Information Malta

Networks

European Surveillance of Congenital Anomalies (EUROCAT)
Austria
Belgium
Croatia
Czechia
Denmark
Finland
France
Germany
Hungary
Ireland
Italy
Malta
Netherlands
Norway
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
First published:
20/02/2024
Network
ENCePP partner

Contact details

Helen Dolk

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme
Other

More details on funding

FP7, Universities
Regulatory

Was the study required by a regulatory body?

No