Varenicline Pregnancy Cohort Study

NCT01290445 | Completed Results

• 1 other identifier: A3051078
• Study Type: observational
• Target: 885,185
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malformations

Keywords

varenicline; smoking; smoking cessation; cohort study; drug safety; prospective study

Outcome Measures

Primary Outcomes (1)

• Number of Infants With Major Congenital Malformations

  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.

  For 12 months after birth

Secondary Outcomes (5)

• Number of Infants With Stillbirths

  At the time of birth

• Number of Infants Born Small for Gestational Age (SGA)

  At the time of birth

• Number of Infants Born Preterm

  At the time of birth

• Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes

  At the time of birth

• Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)

  For 12 months after birth

Study Arms (3)

Exposed

Infants exposed in utero to varenicline

Drug: varenicline

Unexposed

infants exposed in utero to cigarette smoke from maternal smoking

Behavioral: cigarette smoke from maternal smoking

Reference

infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking

Other: Non-Exposure

Interventions

varenicline DRUG

This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.

Also known as: Chantix, Champix

Exposed

cigarette smoke from maternal smoking BEHAVIORAL

This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned.

Unexposed

Non-Exposure OTHER

This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned.

Reference

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.

You may not qualify if:

• Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.

Sponsors & Collaborators

• Pfizer: lead
• University of Aarhus: collaborator
• Karolinska Institutet: collaborator

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 7, 2011
• Study Start: September 13, 2007
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 24, 2023
• Results First Posted: January 22, 2019

Record last verified: 2018-08