Varenicline Pregnancy Cohort Study

Completed

• Conditions: Malformations
• Interventions: Drug: varenicline; Behavioral: cigarette smoke from maternal smoking; Other: Non-Exposure

• Registration Number: NCT01290445
• Lead Sponsor: Pfizer

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.

Detailed Description

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

Study Timeline

• Study Start: 2007-09-13
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-07
• Primary Completion: 2016-05-01
• Study Completion: 2016-05-01
• Results First Submitted: 2017-04-25
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-13
• Results First Posted: 2019-01-22
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 885185

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed	varenicline	Infants exposed in utero to varenicline
Unexposed	cigarette smoke from maternal smoking	infants exposed in utero to cigarette smoke from maternal smoking
Reference	Non-Exposure	infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking

Primary Outcome Measures

Name	Time	Method
Number of Infants With Major Congenital Malformations	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 Outcome Measures

Name	Time	Method
Number of Infants With Stillbirths	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)	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	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	At the time of birth
Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)	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.