Status: Finalised First registered on: 21/11/2014
Last updated on: 23/11/2018
1. Study identification
EU PAS Register NumberEUPAS8001
Official titleHow to classify women exposed to drug prescriptions during pregnancy in pharmaco-epidemiology studies? Method using treatment intensity and individual trajectories of exposure over time
Study title acronym
Study typeOther: Development of new methods in Pharmacoepidemiology
Brief description of the studyPregnancy represents a situation in which the dose, the duration and the period of exposure play an essential role in the occurrence of adverse effects on the newborn. However, these parameters are often insufficiently and inconsistently addressed. Therefore, it is necessary to develop new methods in order to take into account more precisely exposure profiles to drugs during pregnancy in pharmaco-epidemiology studies. The objective of the present study is to propose a new method to classify women according to drug exposure during pregnancy taking into account treatment intensity, duration and evolution. We will apply this method to psychotropic drugs during pregnancy in EFEMERIS.
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 signed14/09/2012
Start date of data collection15/11/2012
Start date of data analysis15/01/2013
Date of interim report, if expected
Date of final study report02/11/201503/12/2015
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 bodyANSM - PHRC100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Damase-Michel
First name Christine
Address line 137 Allees Jules
Address line 2Faculté de Médecine 
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 137 Allees Jules 
Address line 2Faculté de Médecine 
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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