Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Malformations
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded
by the registers.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Varenicline Pregnancy Cohort Study | |||
| Official Title | Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate) | |||
| Brief 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | The study population will consist of all live born and stillborn infants in Denmark and Sweden. | |||
| Condition | Malformations | |||
| Intervention |
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| Study Groups/Cohorts |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 885185 | |||
| Original Estimated Enrollment | 904585 | |||
| Actual Study Completion Date | May 1, 2016 | |||
| Actual Primary Completion Date | May 1, 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | 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. | |||
| Sex/Gender | Not Provided | |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01290445 | |||
| Other Study ID Numbers | A3051078 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators |
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| Investigators |
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| PRS Account | Pfizer | |||
| Verification Date | August 2018 | |||