Varenicline Pregnancy Cohort Study

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NCT01290445

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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.

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MalformationsVarenicline Pregnancy Cohort Study
NCT01290445
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Varenicline Pregnancy Cohort Study
Official Title Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
Brief 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.
Detailed Description Sampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will consist of all live born and stillborn infants in Denmark and Sweden.
Condition Malformations
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 Status Completed
Actual Enrollment
 (submitted: August 13, 2018)		885185
Original Estimated Enrollment
 (submitted: February 3, 2011)		904585
Actual Study Completion Date May 1, 2016
Actual Primary Completion Date May 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/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01290445
Other Study ID Numbers A3051078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators
  • University of Aarhus
  • Karolinska Institutet
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2018