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

Contact details

Yates Laura

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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