Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

VARENICLINE
Population studied

Short description of the study population

Pregnant women which were reported to the TIS whilst the pregnancy was ongoing prior to 24 weeks gestation with or without exposure to varenicline.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Pregnant women

Estimated number of subjects

434
Study design details

Main study objective

Testing the fetal effects of first trimester varenicline use in pregnancy.

Outcomes

The primary aim of this study was to compare the incidence of major and minor congenital malformations between first trimester varenicline exposed pregnancy and non-exposed control pregnancies. Secondary aims included comparison of the spontaneous abortion, elective termination and intrauterine death rates.

Data analysis plan

We will compare the rate of major and minor malformations between exposed and control pregnancies primarily using non-parametric methods (due to small sample size), and where possible include some adjustment for confounding variables using parametric methods (logistic regression). The cumulative incidences of spontaneous abortion, intrauterine death and elective termination will be compared using time dependent cox proportional hazards models. Where possible, adjustment for confounding variables will be undertaken.