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Varenicline Pregnancy Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01290445
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : January 22, 2019
Last Update Posted : January 22, 2019
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 : 885185 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
Actual Study Start Date : September 13, 2007
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : May 1, 2016

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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. Number of Infants With Major Congenital Malformations [ Time Frame: For 12 months after birth ]
    Major congenital malformations were defined as any codes within the Q-chapter of The Tenth Revision of the International Classification of Diseases (ICD-10), excluding certain minor anomalies.


Secondary Outcome Measures :
  1. Number of Infants With Stillbirths [ Time Frame: At the time of birth ]
    Stillbirth was defined as death at a gestational age of greater than or equal to (>=) 22 weeks, with the exception that in Sweden prior to 2008 it was defined as death at a gestational age of >=28 weeks.

  2. Number of Infants Born Small for Gestational Age (SGA) [ Time Frame: At the time of birth ]
    An infant was defined as SGA if birth weight was below the 10th percentile of its sex-specific national distribution at the respective gestational week. Data on birth weight and gestational age from the medical birth registries were used to calculate the 10th percentiles for each sex based on all Danish and Swedish births during the study observation period.

  3. Number of Infants Born Preterm [ Time Frame: At the time of birth ]
    Preterm birth was defined as birth before the gestational age of 37 weeks.

  4. Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes [ Time Frame: At the time of birth ]
  5. Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS) [ Time Frame: For 12 months after birth ]
    Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age.


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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01290445    
Other Study ID Numbers: A3051078
First Posted: February 7, 2011    Key Record Dates
Results First Posted: January 22, 2019
Last Update Posted: January 22, 2019
Last Verified: August 2018
Keywords provided by Pfizer:
varenicline
smoking
smoking cessation
 cohort study
drug safety
prospective study
Additional relevant MeSH terms:
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Congenital Abnormalities
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs