Trials / Completed
CompletedNCT01290445
Varenicline Pregnancy Cohort Study
Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 885,185 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | varenicline | This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned. |
| BEHAVIORAL | cigarette smoke from maternal smoking | This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned. |
| OTHER | Non-Exposure | This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned. |
Timeline
- Start date
- 2007-09-13
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2011-02-07
- Last updated
- 2023-07-24
- Results posted
- 2019-01-22
Source: ClinicalTrials.gov record NCT01290445. Inclusion in this directory is not an endorsement.