Varenicline Pregnancy Cohort Study

Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)

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.

Study Overview

• Status: Completed
• Conditions: Malformations
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 885185

Participation Criteria

Eligibility Criteria

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Infants With Stillbirths	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.	At the time of birth
Number of Infants Born Small for Gestational Age (SGA)	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.	At the time of birth
Number of Infants Born Preterm	Preterm birth was defined as birth before the gestational age of 37 weeks.	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)	Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age.	For 12 months after birth

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Karolinska Institutet; University of Aarhus
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2007
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimated): February 7, 2011

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: smoking; smoking cessation; cohort study; varenicline; prospective study; drug safety
• Additional Relevant MeSH Terms: Congenital Abnormalities; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: A3051078