Status: Finalised First registered on: 05/12/2013
Last updated on: 20/12/2016
1. Study identification
EU PAS Register NumberEUPAS5356
Official titleVeinotonics in pregnancy: a comparative study in the EFEMERIS database
Study title acronym
Study typeObservational study
Brief description of the studyThere are few published data about possible effects of veinotonics in pregnant women. However, many French women use these medications during their pregnancy. The aim of the study is to investigate potential adverse drug reactions of veinotonics in pregnancy. The study is conducted in EFEMERIS, a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire d'Assurance Maladie of Haute-Garonne) and outcomes (data from Maternal and Infant Protection Service and from Antenatal diagnosis Centre). Women who delivered from July 1st 2004 to December 31th 2007 in Haute-Garonne (time period when veinotonics were still reimbursed) and were registered in the French Health Insurance Service have been included. We compare pregnancy outcomes and newborn health between women exposed to veinotonics during pregnancy and unexposed women.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsPharmacoepidemiology INSERM 1027
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Website/Homepagehttp://www.u1027.inserm.fr/
Details of (Primary) lead investigator
Title Dr
Last name Damase-Michel
First name Christine
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/09/2012
Start date of data collection01/09/2012
Start date of data analysis01/10/2012
Date of interim report, if expected
Date of final study report01/04/201401/04/2014
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 bodyAgence Nationale de Sécurité du Médicament et des produits de santé (ANSM), the Clinical Research Hospital Program100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Damase-Michel
First name Christine
Address line 1Faculté de médecine, Service de pharmacologie clinique
Address line 237 Allees Jules guesde 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33-561145904 
Alternative phone number 
Fax number (incl. country code) 
Email address christine.damase-michel@univ-tlse3.fr
Public Enquiries
Title Dr 
Last name Damase-Michel 
First name Christine 
Address line 1Faculté de médecine, Service de pharmacologie clinique 
Address line 237 Allees Jules guesde 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33-561145904 
Alternative phone number 
Fax number (incl. country code) 
Email address christine.damase-michel@univ-tlse3.fr 
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