A Population-based Study of the Safety of Gabapentin Use During Pregnancy

Study identification

• EU PAS number:
  EUPAS38620
• Study ID:
  49994
• Official title and acronym:
  A Population-based Study of the Safety of Gabapentin Use During Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  This non-interventional study is being conducted to characterize the use and safety of gabapentin during pregnancy
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Multiple centres: 4 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 21/12/2020

Actual: 21/12/2020

Study start date

Planned: 30/12/2020

Actual: 30/12/2020

Data analysis start date

Planned: 30/04/2021

Actual: 30/04/2021

Date of final study report

Planned: 31/03/2022

Actual: 08/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

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)

Other study registration identification numbers and links

A9451182