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Varenicline Pregnancy Cohort Study

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ClinicalTrials.gov Identifier: NCT01290445
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : July 4, 2016
Sponsor:
Collaborators:
University of Aarhus
Karolinska Institutet
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment
Malformations Drug: varenicline Behavioral: cigarette smoke from maternal smoking Other: Non-Exposure

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

Study Design
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Varenicline Pregnancy Cohort Study Protocol Chantix (Registered)/Champix-(Registered) (Varenicline Tartrate)
Study Start Date : April 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. prevalence of major congenital malformation [ Time Frame: 1 year after birth ]

Secondary Outcome Measures :
  1. prevalence of stillbirth [ Time Frame: approximately 40 weeks of gestational age ]
  2. prevalence of low birth weight [ Time Frame: approximately 40 weeks of gestational age ]
  3. prevalence of pre-term delivery [ Time Frame: approximately 40 weeks of gestational age ]
  4. prevalence of premature rupture of membranes [ Time Frame: approximately 40 weeks of gestational age ]
  5. prevalence of sudden infant death syndrome [ Time Frame: 1 year after birth ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290445


Sponsors and Collaborators
Pfizer
University of Aarhus
Karolinska Institutet
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01290445     History of Changes
Other Study ID Numbers: A3051078
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: June 2016

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
Physiological Effects of Drugs