Status: Finalised First registered on: 27/12/2018
Last updated on: 25/08/2020
1. Study identification
EU PAS Register NumberEUPAS27339
Official titleA Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes
Study title acronym
Study typeObservational study
Brief description of the studyThe study objectives are to describe the use of pregabalin exposure in pregnancy and to estimate the risk of major congenital malformations, birth outcomes other than congenital malformations and neurodevelopmental outcomes with the use of pregabalin.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableA0081359
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupDepartment of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Website/Homepagewww.kea.au.dk
Details of (Primary) lead investigator
Title Professor
Last name Ehrenstein
First name Vera
Is this study being carried out with the collaboration of a research network?
Yes
Department of clinical epidemiology
Centre for Pharmacoepidemiology
EPID Research
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Centre for Pharmacoepidemiology (CPE)
IQVIA
Aarhus University Dept. of Clinical Epidemiology
University of Bergen,, Norway
Countries in which this study is being conducted
International study

Denmark
Finland
Norway
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/06/201815/06/2018
Start date of data collection30/12/201830/12/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/201901/06/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Asomaning
First name Kofi
Address line 1500 Arcola Road
Address line 2 
Address line 3 
CityCollegeville 
Postcode 
CountryUnited States
Phone number (incl. country code)1-484-8655557 
Alternative phone number 
Fax number (incl. country code) 
Email address kofi.asomaning@pfizer.com
Public Enquiries
Title Dr 
Last name Asomaning 
First name Kofi 
Address line 1500 Arcola Road 
Address line 2 
Address line 3 
CityCollegeville 
Postcode 
CountryUnited States 
Phone number (incl. country code)1-484-8655557 
Alternative phone number 
Fax number (incl. country code) 
Email address kofi.asomaning@pfizer.com 
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