Status: Ongoing First registered on: 27/06/2014
Last updated on: 23/11/2016
1. Study identification
EU PAS Register NumberEUPAS6934
Official titlePregnancy outcome after in utero exposure to baclofen: an ENTIS collaborative study
Study title acronymBaclofen and pregnancy
Study typeObservational study
Brief description of the studyObjective: To evaluate the risk of early in utero exposure to baclofen and to describe neonatal symptoms after 3rd trimester baclofen exposure. Design: all prospectively assessed cases collected from 1st January 1990 up to 28th February 2012 with baclofen exposure during the first trimester of pregnancy. Study group: pregnant women exposed to baclofen between week 4 and week 12 of pregnancy and with prospectively ascertained outcome. Patients exposed to major teratogens (acitretin, isotretinoin, methotrexate, mycophenolate, thalidomide, valproic acid) or patients with malignancies or malignancy-related conditions are excluded. General control group: pregnant women exposed to a non-teratogenic agent with prospectively ascertained outcome and same exclusion criteria as above. Patients from both groups are matched according to maternal age ± 2 years, gestational age at inclusion ± 2 weeks, year of counseling ± 2 years, TIS or country with 3 controls per case. Primary objectives: Rate of major birth defects, rate of spontaneous abortion. Secondary objectives: Intrauterine growth retardation (IUGR) in malformed and non-malformed newborns, prematurity rate (< 37 gestational weeks), rate of elective terminations of pregnancy (ETOPs). Description of postnatal symptoms. Analysis will consider counfounders with adjustments for parity, previous spontaneous abortions, previous children/fetuses with major birth defects, tobacco, alcohol intake. Statistical analysis. - Continuous endpoints comparison: Student's t test. - Categorical endpoints comparison: χ² test or Fisher's exact test when assumptions for χ² are not met. - If a difference is pointed out: logistic regression analysis taking into account all identified possible confounding factors. With 100 exposed cases the study has a 80% power of detecting a 3.5-fold increase in malformation rate, assuming a 3% baseline risk
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 belongsCRPV Lyon
Department/Research groupCentre de Pharmacovigilance
Organisation/affiliationACRPV / ENTIS
Website/Homepagehttp://afcrpv.herokuapp.com/ or http://entis.herokuapp.com/
Details of (Primary) lead investigator
Title Dr
Last name BERNARD
First name Nathalie
Is this study being carried out with the collaboration of a research network?
Yes

ACRPV
ENTIS
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?22

Embryotox Berlin
Netherlands Pharmacovigilance Centre Lareb
CRPV Lyon
Countries in which this study is being conducted
International study

France
Germany
Israel
Italy
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/12/201114/12/2011
Start date of data collection01/12/201201/12/2012
Start date of data analysis01/02/201301/04/2013
Date of interim report, if expected30/04/201430/04/2014
Date of final study report30/09/2014
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 body
Research councils
EU funding scheme
OtherENTIS50
ACRPV50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name BERNARD-PHALIPPON
First name Nathalie
Address line 1Centre de Pharmacovigilance
Address line 2162 avenue Lacassagne 
Address line 3 
CityLyon 
Postcode69003 
CountryFrance
Phone number (incl. country code)33472116997 
Alternative phone number 
Fax number (incl. country code)33472116985 
Email address nathalie.bernard-phalippon@chu-lyon.fr
Public Enquiries
Title Dr 
Last name BERNARD 
First name Nathalie 
Address line 1Centre de Pharmacovigilance 
Address line 2162 avenue Lacassagne 
Address line 3 
CityLyon 
Postcode69003 
CountryFrance 
Phone number (incl. country code)33472116997 
Alternative phone number33472119393 
Fax number (incl. country code)33472116985 
Email address nathalie.bernard-phalippon@chu-lyon.fr 
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