Skip to main content

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

Objective

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 anomaly 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 3 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 pregnant 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.

Call for proposal

FP7-HEALTH-2010-single-stage
See other projects for this call

Coordinator

UNIVERSITY OF ULSTER
Address
Cromore Road
BT52 1SA Coleraine
United Kingdom
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 093 379,95
Administrative Contact
Anne Marie Patton (Dr.)

Participants (8)

RIJKSUNIVERSITEIT GRONINGEN
Netherlands
EU contribution
€ 441 261,60
Address
Broerstraat 5
9712CP Groningen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jan Poutsma (Dr.)
UNIVERSITY OF BATH
United Kingdom
EU contribution
€ 232 000,80
Address
Claverton Down
BA2 7AY Bath
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Fiona Wallis (Ms.)
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 242 976,40
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
J J Breeuwsma (Mr.)
REGION SYDDANMARK
Denmark
EU contribution
€ 333 975,75
Address
Damhaven 12
7100 Vejle
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Ester Garne (Dr.)
UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU
Poland
EU contribution
€ 237 821,25
Address
Ul. Fredry 10
61-701 Poznan
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Bozena Raducha (Dr.)
CONSIGLIO NAZIONALE DELLE RICERCHE
Italy
EU contribution
€ 155 823
Address
Piazzale Aldo Moro 7
00185 Roma
Activity type
Research Organisations
Administrative Contact
Marco Borbotti (Mr.)
SWANSEA UNIVERSITY
United Kingdom
EU contribution
€ 221 938,45
Address
Singleton Park
SA2 8PP Swansea
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Julie Williams (Ms.)
QUEEN MARY UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 36 922,80
Address
327 Mile End Road
E1 4NS London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Szendeffy Tanya (Ms.)