Status: Finalised First registered on: 23/11/2018
Last updated on: 23/11/2018
1. Study identification
EU PAS Register NumberEUPAS26684
Official titleAntidepressants during pregnancy: a French drug utilisation study in EFEMERIS cohort.
Study title acronym
Study typeObservational study
Brief description of the studyPrevious studies have suggested that exposure to some antidepressants (AD) during pregnancy could be associated with an increased risk of congenital malformations and neurodevelopment disorders for the child. We conducted a study to describe the use of AD during pregnancy in France. We performed a drug utilisation study in EFEMERIS, a French cohort of pregnant women. At the time of the present study, 89,170 pregnant women, who were pregnant from 2005 to 2014 in Haute-Garonne were included.
Was this study requested by a regulator?Yes:
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 signed15/09/201615/09/2016
Start date of data collection01/10/201601/10/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report01/01/201801/01/2018
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 scheme
OtherANSM100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Damase-Michel
First name Christine
Address line 137 Allees Jules
Address line 2 
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 2 
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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