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Varenicline Pregnancy Cohort Study

Last updated on May 10, 2018

FOR MORE INFORMATION
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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Similar Trials

Malformations
NCT01290445
All Genders
Varenicline Pregnancy Cohort Study
Varenicline Pregnancy Cohort Study Protocol Chantix (Registered)/Champix-(Registered) (Varenicline Tartrate)
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.
Sampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The study population will consist of all live born and stillborn infants in Denmark and Sweden.
Malformations
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
May 2016
May 2016   (Final data collection date for primary outcome measure)

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.

Not Provided
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01290445
A3051078
No
Not Provided
Not Provided
Pfizer
Pfizer
  • University of Aarhus
  • Karolinska Institutet
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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