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Varenicline Pregnancy Cohort Study

NCT01290445 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 885185

Last updated 2023-07-24

Study results available
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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.

Conditions

  • Malformations

Interventions

DRUG

varenicline

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

BEHAVIORAL

cigarette smoke from maternal smoking

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

OTHER

Non-Exposure

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-13
Primary Completion
2016-05-01
Completion
2016-05-01

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01290445 on ClinicalTrials.gov