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Varenicline Pregnancy Cohort Study

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ClinicalTrials.gov Identifier: NCT01290445
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Collaborators:
University of Aarhus
Karolinska Institutet
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Malformations
Interventions Drug: varenicline
Behavioral: cigarette smoke from maternal smoking
Other: Non-Exposure
Enrollment 885185
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description Participants included infants who were exposed to varenicline in utero. Participants included infants who were exposed to maternal smoking, but not to varenicline in utero. Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
Period Title: Overall Study
Started 335 78412 806438
Completed 335 78412 806438
Not Completed 0 0 0
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort Total
Hide Arm/Group Description Participants included infants who were exposed to varenicline in utero. Participants included infants who were exposed to maternal smoking, but not to varenicline in utero. Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero. Total of all reporting groups
Overall Number of Baseline Participants 335 78412 806438 885185
Hide Baseline Analysis Population Description
Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Infants
Number Analyzed 335 participants 78412 participants 806438 participants 885185 participants
Less Than (<) 32 weeks 3 1036 6275 7314
32-36 weeks 22 5137 40457 45616
Greater Than or Equal to (>=) 37 weeks 310 72239 759706 832255
[1]
Measure Description: Reported age is the gestational age of infants.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Infants
Number Analyzed 335 participants 78412 participants 806438 participants 885185 participants
Female 156 38044 392755 430955
Male 179 40328 413485 453992
Unknown 0 40 198 238
1.Primary Outcome
Title Number of Infants With Major Congenital Malformations
Hide Description 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.
Time Frame For 12 months after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all live born infants in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description:
Participants included infants who were exposed to varenicline in utero.
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
Overall Number of Participants Analyzed 334 78028 804020
Measure Type: Number
Unit of Measure: infants
12 3382 33950
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.46 to 1.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.45 to 1.42
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Infants With Stillbirths
Hide Description 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.
Time Frame At the time of birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description:
Participants included infants who were exposed to varenicline in utero.
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
Overall Number of Participants Analyzed 335 78412 806438
Measure Type: Number
Unit of Measure: infants
1 384 2418
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.09 to 4.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.09 to 4.67
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Infants Born Small for Gestational Age (SGA)
Hide Description 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.
Time Frame At the time of birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description:
Participants included infants who were exposed to varenicline in utero.
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
Overall Number of Participants Analyzed 335 78412 806438
Measure Type: Number
Unit of Measure: infants
42 13433 73135
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.50 to 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.51 to 0.97
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Infants Born Preterm
Hide Description Preterm birth was defined as birth before the gestational age of 37 weeks.
Time Frame At the time of birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description:
Participants included infants who were exposed to varenicline in utero.
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
Overall Number of Participants Analyzed 335 78412 806438
Measure Type: Number
Unit of Measure: infants
25 6173 46732
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.63 to 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.61 to 1.37
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes
Hide Description [Not Specified]
Time Frame At the time of birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description:
Participants included infants who were exposed to varenicline in utero.
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
Overall Number of Participants Analyzed 335 78412 806438
Measure Type: Number
Unit of Measure: infants
12 4246 30641
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.37 to 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline Exposed Cohort, Varenicline Unexposed Cohort
Comments Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.37 to 1.16
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)
Hide Description Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age.
Time Frame For 12 months after birth
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012. Here, ‘Number of participants analyzed’ signifies participants who were evaluable for this outcome measure.
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description:
Participants included infants who were exposed to varenicline in utero.
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
Overall Number of Participants Analyzed 307 71720 755939
Measure Type: Number
Unit of Measure: infants
0 51 58
Time Frame [Not Specified]
Adverse Event Reporting Description Since this was a non interventional study using secondary data sources, collection and reporting of adverse events were not applicable.
 
Arm/Group Title Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Hide Arm/Group Description Participants included infants who were exposed to varenicline in utero. Participants included infants who were exposed to maternal smoking, but not to varenicline in utero. Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
All-Cause Mortality
Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline Exposed Cohort Varenicline Unexposed Cohort Reference Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01290445     History of Changes
Other Study ID Numbers: A3051078
First Submitted: January 25, 2011
First Posted: February 7, 2011
Results First Submitted: April 25, 2017
Results First Posted: January 21, 2019
Last Update Posted: January 21, 2019