Varenicline use in pregnancy

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS11672
• Study ID:
  16556
• Official title and acronym:
  Varenicline use in pregnancy
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Finland

  France

  Germany

  Israel

  Netherlands

  Türkiye

  United Kingdom
• Study description:
  The aim of this study is to assess some of the fetal risks posed by maternal use of varenicline during pregnancy.The primary objectives are to evaluate the occurrence of congenital malformation (both major and minor) following varenicline exposure in the first trimester, spontaneous abortion (defined as spontaneous fetal loss prior to 24 weeks gestation) or intrauterine death/fetal demise or stillbirth (defined as fetal loss from 24 weeks gestation onwards). As a secondary objective we aim to perform an evaluation of the incidence of elective termination, including an assessment of the gestational age at which this occurred, and where sufficient details are available, the indication for elective termination.
• Study status:
  Finalised

Research institutions and networks

Institutions

The UK Teratology Information Service

Networks

European Network of Teratology Information Services (ENTIS)

Austria

Czechia

Finland

France

Germany

Greece

Ireland

Italy

Netherlands

Spain

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned:01/06/2013

Actual:01/06/2013

Study start date

Planned:01/05/2014

Actual:10/07/2014

Data analysis start date

Planned:01/08/2014

Actual:21/05/2015

Date of final study report

Planned:05/06/2016

Actual:05/06/2016

Sources of funding

Other

More details on funding

Funding bodies of individual TIS within ENTIS

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable