Skip to main content
OpenTrials
Completed

NCT Number: NCT01290445

Varenicline Pregnancy Cohort Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malformations Behavior Health Behavior Smoking Smoking Cessation

Sex eligibility

All sexes

Study type

Observational

About this study

Sampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varenicline

Drug

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

Other names: Chantix, Champix

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Karolinska Institutet
  • University of Aarhus

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2011
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.