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
  Purpose

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.


Condition Intervention Phase
Malformations
Drug: varenicline
Behavioral: cigarette smoke from maternal smoking
Other: Non-Exposure
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Varenicline Pregnancy Cohort Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • prevalence of major congenital malformation [ Time Frame: 1 year after birth ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 904585
Study Start Date: April 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposed
Infants exposed in utero to varenicline
Drug: varenicline
This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.
Other Name: Chantix, Champix
Unexposed
infants exposed in utero to cigarette smoke from maternal smoking
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.
Reference
infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking
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.

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of all live born and stillborn infants in Denmark and Sweden.

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290445

Sponsors and Collaborators
Pfizer
University of Aarhus
Karolinska Institutet
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01290445     History of Changes
Other Study ID Numbers: A3051078
Study First Received: January 25, 2011
Last Updated: April 16, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Pfizer:
varenicline
smoking
smoking cessation
cohort study
drug safety
prospective study

Additional relevant MeSH terms:
Congenital Abnormalities
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014