Varenicline Pregnancy Cohort Study

NCT ID: NCT01290445

Last Updated: 2023-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

885185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-13

Study Completion Date

2016-05-01

Brief Summary

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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.

Detailed Description

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Sampling will not be employed. The data sources record nearly all (\>98.6%) births in Denmark and Sweden.

Conditions

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Malformations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed

Infants exposed in utero to varenicline

varenicline

Intervention Type DRUG

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

Unexposed

infants exposed in utero to cigarette smoke from maternal smoking

cigarette smoke from maternal smoking

Intervention Type BEHAVIORAL

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

Reference

infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking

Non-Exposure

Intervention Type OTHER

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

Interventions

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varenicline

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

Intervention Type DRUG

cigarette smoke from maternal smoking

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

Intervention Type BEHAVIORAL

Non-Exposure

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

Intervention Type OTHER

Other Intervention Names

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Chantix, Champix

Eligibility Criteria

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Inclusion Criteria

All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.

Exclusion Criteria

Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A3051078

Identifier Type: -

Identifier Source: org_study_id

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