Study identification

PURI

https://redirect.ema.europa.eu/resource/36881

EU PAS number

EUPAS27339

Study ID

36881

Official title and acronym

A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes

DARWIN EU® study

No

Study countries

Denmark
Finland
Norway
Sweden

Study description

The 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.

Study status

Finalised
Research institution and networks

Institutions

University of Bergen Norway, Department of clinical epidemiology, Centre for Pharmacoepidemiology, EPID Research

Contact details

Vera Ehrenstein

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Study protocol
Initial protocol

Pregabalin Pregnancy Outcomes Study Protocol Final 23NOV 2018 CLEAN

English (859.6 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)