Study identification

PURI

https://redirect.ema.europa.eu/resource/16381

EU PAS number

EUPAS6934

Study ID

16381

Official title and acronym

Pregnancy outcome after in utero exposure to baclofen: an ENTIS collaborative study (Baclofen and pregnancy)

DARWIN EU® study

No

Study countries

France
Germany
Israel
Italy
Netherlands
United Kingdom

Study description

Objective: 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

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Nathalie BERNARD

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Other

More details on funding

ENTIS, ACRPV
Study protocol
Initial protocol

Baclofen Protocol Final

English (41.11 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable