MalformationsNCT01290445
Varenicline Pregnancy Cohort Study
An observational study of Malformations, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malformations
- What is being tested?
- varenicline, cigarette smoke from maternal smoking and Non-Exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 885,185 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2007to 1 May 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of all live born and stillborn infants in Denmark and Sweden.
Who may be able to join
- All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.
Who cannot join
- Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.
About this study
Official title: Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
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.
Read the detailed description
Sampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.
- Conditions
- Malformations
- Being tested
- varenicline, cigarette smoke from maternal smoking, Non-Exposure
- Keywords
- varenicline, smoking, smoking cessation, cohort study, drug safety, prospective study
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix, Champix
This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.
cigarette smoke from maternal smokingBehavioural
This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned.
Non-ExposureOther
This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Infants exposed in utero to varenicline Receives: Drug: varenicline | |
| Unexposed | infants exposed in utero to cigarette smoke from maternal smoking Receives: Behavioral: cigarette smoke from maternal smoking | |
| Reference | infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking Receives: Other: Non-Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 12 months after birth
Secondary outcomes (5)
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.
Measured: 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.
Measured: At the time of birth
Number of Infants Born Preterm
Preterm birth was defined as birth before the gestational age of 37 weeks.
Measured: At the time of birth
Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes
Measured: 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.
Measured: For 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study start13 Sep 2007
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalformationsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 885,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Aarhus, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290445
- Sponsor's protocol ID
- A3051078
- Status last verified
- Aug 2018
- First submitted
- 25 Jan 2011
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)
- ClinicalTrials.gov ID
- NCT01290445
- Acronym / sponsor ID
- A3051078
- Conditions
- Malformations
- Keywords
- varenicline, smoking, smoking cessation, cohort study, drug safety, prospective study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 885,185 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- University of Aarhus, Karolinska Institutet
- Study start
- 13 Sep 2007 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Drug: vareniclineInfants exposed in utero to varenicline |
| Unexposed | – | Behavioral: cigarette smoke from maternal smokinginfants exposed in utero to cigarette smoke from maternal smoking |
| Reference | – | Other: Non-Exposureinfants not exposed in utero to either varenicline or cigarette smoke from maternal smoking |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of all live born and stillborn infants in Denmark and Sweden.
Key inclusion criteria (1 listed)
- All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.
Key exclusion criteria (1 listed)
- Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vareniclineAlso: Chantix, ChampixThis is a non-interventional study. Exposure in utero to varenicline is observed, not assigned. | Drug | Exposed |
| cigarette smoke from maternal smokingThis is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned. | Behavioural | Unexposed |
| Non-ExposureThis is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned. | Other | Reference |
Primary outcome
Number of Infants With Major Congenital Malformations
Time frame: For 12 months after birth
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.
5 secondary outcomes
Number of Infants With Stillbirths
Time frame: At the time of birth
Number of Infants Born Small for Gestational Age (SGA)
Time frame: At the time of birth
Number of Infants Born Preterm
Time frame: At the time of birth
Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes
Time frame: At the time of birth
Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)
Time frame: For 12 months after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Malformations, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Infants With Major Congenital Malformations (time frame: For 12 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.