CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 885,185 enrolled
Drug / intervention
varenicline +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01290445
NCT01290445N/ACompleted
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Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)

Pfizer·observational·Posted Feb 7, 2011·Updated Jul 24, 2023

In Brief

An observational study evaluating varenicline, cigarette smoke from maternal smoking, and 1 other intervention for Malformations. Completed, enrolled 885,185 participants.

Detailed Summary

A prospective population-based cohort study to examine whether varenicline use during pregnancy is associated with an increased risk of major congenital malformations in infants above that associated with smoking during pregnancy.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMalformations
Countries--
CollaboratorsUniversity of Aarhus, Karolinska Institutet

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2011
Enrollment StartSep 13, 2007
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 15.4 years ago

Interventions

vareniclinedrug

This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.

cigarette smoke from maternal smokingbehavioral

This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned.

Non-Exposureother

This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned.