InfluenzaNCT00401700
Influenza Vaccine Postpartum Questionnaire
An observational study of Influenza and Vaccine, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this trial is to assess the knowledge and attitudes of post-partum women regarding influenza and the use of the influenza vaccine in pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: pregnant women
Who may be able to join
- women admitted to the postpartum floor during the study period
Who cannot join
- inability to read or understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability and Feasibility of Influenza Vaccine Administration on the Post-partum Floor Prior to Discharge Home During Flu Season
The purpose of this trial is to assess the knowledge and attitudes of post-partum women regarding influenza and the use of the influenza vaccine in pregnancy.
Read the detailed description
Women on our post-partum floor will be approached to complete a questionnaire which will assess their knowledge and attitudes regarding influenza and the use of the influenza vaccine in pregnancy. The study will take place over a 2-month period during influenza season, and at the time when the influenza vaccine becomes available.
- Keywords
- influenza, influenza vaccine, pregnancy
- Medical subject headings
- Influenza, Human
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark H Yudin, MD, MSc, Principal investigator, St. Michael's Hospital (Toronto, Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401700
- Sponsor's protocol ID
- 06-190
- Status last verified
- Feb 2019
- First submitted
- 17 Nov 2006
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of Influenza Vaccine Administration on the Post-partum Floor Prior to Discharge Home During Flu Season
- ClinicalTrials.gov ID
- NCT00401700
- Acronym / sponsor ID
- 06-190
- Keywords
- influenza, influenza vaccine, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess the knowledge and attitudes of post-partum women regarding influenza and the use of the influenza vaccine in pregnancy.
Detailed description
Women on our post-partum floor will be approached to complete a questionnaire which will assess their knowledge and attitudes regarding influenza and the use of the influenza vaccine in pregnancy. The study will take place over a 2-month period during influenza season, and at the time when the influenza vaccine becomes available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (1 listed)
- women admitted to the postpartum floor during the study period
Key exclusion criteria (1 listed)
- inability to read or understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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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.
Mark H Yudin, MD, MSc principal investigator
St. Michael's Hospital (Toronto, Canada)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Vaccine, run by Unity Health Toronto at 1 site in Canada.
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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 Feb 2019.