Status: Ongoing First registered on: 11/10/2011
Last updated on: 29/01/2012
1. Study identification
EU PAS Register NumberEUPAS2221
Official titleEUROmediCAT: Safety of Medication Use in Pregnancy in Relation to Risk of Congenital Malformations
Study title acronymEUROmediCAT
Study typeActive surveillance
Brief description of the studyA 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsMFIR-Ulster
Department/Research groupCentre for Maternal, Fetal and Infant Research
Organisation/affiliationUniversity of Ulster
Website/Homepagehttp://www.science.ulster.ac.uk/inr/mfir.php / http://euromedicat.eu/
Details of (Primary) lead investigator
Title Professor
Last name Dolk
First name Helen
Is this study being carried out with the collaboration of a research network?
Yes

EUROCAT
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?17

MFIR-Ulster
University of Bath
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
Countries in which this study is being conducted
International study

Belgium
Denmark
France
Ireland
Italy
Malta
Netherlands
Norway
Poland
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/02/2011
Start date of data collection01/03/2011
Start date of data analysis01/09/2011
Date of interim report, if expected31/10/2012
Date of final study report29/05/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeFP775
OtherUniversities25
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Dolk
First name Helen
Address line 1University of Ulster
Address line 2Shore Rd 
Address line 3 
CityNewtownabbey 
PostcodeBT370QB 
CountryUnited Kingdom
Phone number (incl. country code)442890368540 
Alternative phone number 
Fax number (incl. country code)442890368341 
Email address h.dolk@ulster.ac.uk
Public Enquiries
Title Professor 
Last name Dolk 
First name Helen 
Address line 1University of Ulster 
Address line 2Shore Rd 
Address line 3 
CityNewtownabbey 
PostcodeBT370QB 
CountryUnited Kingdom 
Phone number (incl. country code)442890368540 
Alternative phone number 
Fax number (incl. country code)442890368341 
Email address h.dolk@ulster.ac.uk 
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