Varenicline Pregnancy Cohort Study

Pfizer885,185 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

885,185

Conditions

Malformations

Interventions

vareniclineDRUG

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

cigarette smoke from maternal smokingBEHAVIORAL

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

Non-ExposureOTHER

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: For 12 months after birth

Secondary Outcomes

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.

Time frame: 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.

Time frame: At the time of birth

Number of Infants Born Preterm

Preterm birth was defined as birth before the gestational age of 37 weeks.

Time frame: At the time of birth

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

Time frame: 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.

Time frame: For 12 months after birth

Data from ClinicalTrials.gov

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