Varenicline Pregnancy Cohort Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Aarhus
Karolinska Institutet
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01290445
First received: January 25, 2011
Last updated: April 16, 2014
Last verified: April 2014

January 25, 2011
April 16, 2014
April 2007
December 2015   (final data collection date for primary outcome measure)
prevalence of major congenital malformation [ Time Frame: 1 year after birth ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01290445 on ClinicalTrials.gov Archive Site
  • prevalence of stillbirth [ Time Frame: approximately 40 weeks of gestational age ] [ Designated as safety issue: Yes ]
  • prevalence of low birth weight [ Time Frame: approximately 40 weeks of gestational age ] [ Designated as safety issue: Yes ]
  • prevalence of pre-term delivery [ Time Frame: approximately 40 weeks of gestational age ] [ Designated as safety issue: Yes ]
  • prevalence of premature rupture of membranes [ Time Frame: approximately 40 weeks of gestational age ] [ Designated as safety issue: Yes ]
  • prevalence of sudden infant death syndrome [ Time Frame: 1 year after birth ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Varenicline Pregnancy Cohort Study
Varenicline Pregnancy Cohort Study

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.
 
Enrolling by invitation
904585
December 2015
December 2015   (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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01290445
A3051078
No
Pfizer
Pfizer
  • University of Aarhus
  • Karolinska Institutet
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP