Varenicline Pregnancy Cohort Study

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

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

Conditions
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Malformations

Intervention / Treatment
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* Drug: varenicline
* Behavioral: cigarette smoke from maternal smoking
* Other: Non-Exposure


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>Infants exposed in utero to varenicline | Drug: varenicline<br>* This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.<br>* Other names: Chantix, Champix;|
| Unexposed<br>infants exposed in utero to cigarette smoke from maternal smoking | Behavioral: cigarette smoke from maternal smoking<br>* This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned.<br>|
| Reference<br>infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking | Other: Non-Exposure<br>* This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varenicline, smoking, smoking cessation, cohort study, drug safety, prospective study