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Varenicline Pregnancy Cohort Study

Last updated on November 21, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Malformations
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT01290445
Pfizer
Completed
Varenicline Pregnancy Cohort Study

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Descriptive Information
Brief TitleVarenicline Pregnancy Cohort Study
Official TitleVarenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
Brief SummaryA 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 DescriptionSampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe study population will consist of all live born and stillborn infants in Denmark and Sweden.
ConditionMalformations
Intervention
  • Drug: varenicline
    This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.
    Other Name: Chantix, Champix
  • 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.
Study Groups/Cohorts
  • Exposed
    Infants exposed in utero to varenicline
    Intervention: Drug: varenicline
  • Unexposed
    infants exposed in utero to cigarette smoke from maternal smoking
    Intervention: Behavioral: cigarette smoke from maternal smoking
  • Reference
    infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking
    Intervention: Other: Non-Exposure
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: August 13, 2018)
885185
Original Estimated Enrollment
 (submitted: February 3, 2011)
904585
Actual Study Completion DateMay 1, 2016
Actual Primary Completion DateMay 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/GenderNot Provided
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01290445
Other Study ID NumbersA3051078
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
Collaborators
  • University of Aarhus
  • Karolinska Institutet
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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