Varenicline Pregnancy Cohort Study
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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
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Condition or disease | Intervention/treatment |
---|---|
Malformations | Drug: varenicline Behavioral: cigarette smoke from maternal smoking Other: Non-Exposure |
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 |
Group/Cohort | Intervention/treatment |
---|---|
Exposed
Infants exposed in utero to varenicline
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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
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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. |
- 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.
- 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.
- 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.
- 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.
- Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes [ Time Frame: At the time of birth ]
- 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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 |
varenicline smoking smoking cessation |
cohort study drug safety prospective study |
Congenital Abnormalities Varenicline Nicotinic Agonists Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |