Status: Finalised First registered on: 21/11/2014
Last updated on: 30/01/2017
1. Study identification
EU PAS Register NumberEUPAS7994
Official titleAsthma medication during pregnancy : a cohort study in EFEMERIS
Study title acronym
Study typeObservational study
Brief description of the studyAsthma affects around 8% of pregnant women. Studies show that women experience changes in prescriptions for asthma medications during pregnancy, maybe because of concerns about their possible adverse effects on the fetus. The objective of the study is to describe asthma medications before and during pregnancy in France and to assess the possible association between asthma medications and adverse pregnancy outcomes. Women from EFEMERIS, a French database including prescribed and dispensed reimbursed drugs during pregnancy and pregnancy outcomes, who delivered between July 1, 2005 and December 31, 2012 will be included. Women with at least 2 dispensations for any asthma medication (ATC code R03) from the 30 days prior to conception through their date of delivery will be considered asthmatic. First, a description of prescription of asthma medications will be made. Second, we will compare pregnancy outcomes and newborn health between asthmatic and non-asthmatic 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 signed01/01/201501/01/2015
Start date of data collection01/01/201501/01/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201631/12/2016
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 des Médicaments et produits de santé (ANSM), 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 137 Allees Jules Guesde
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33561145904 
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 Guesde 
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33561145904 
Alternative phone number 
Fax number (incl. country code) 
Email address christine.damase-michel@univ-tlse3.fr 
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