Varenicline Pregnancy Cohort Study

Pfizer

Status: Completed

Conditions: Malformations

Treatments: Other: Non-Exposure; Drug: varenicline; Behavioral: cigarette smoke from maternal smoking

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01290445

A3051078

Details and patient eligibility

About

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.

Full description

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

Enrollment: 885,185 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

885,185 participants in 3 patient groups

Exposed

Description:

Infants exposed in utero to varenicline

Treatment:

Drug: varenicline

Unexposed

Description:

infants exposed in utero to cigarette smoke from maternal smoking

Treatment:

Behavioral: cigarette smoke from maternal smoking

Reference

Description:

infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking

Treatment:

Other: Non-Exposure