InfluenzaNCT00593970
Influenza Vaccine in Pregnancy Part 2
An observational study of Influenza and Pregnancy, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Pregnant women have limited knowledge regarding influenza, its implications during pregnancy, and recommendations for vaccination during pregnancy. The researchers plan to distribute an information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits, and then give a questionnaire on the… Read more about this study
- Who is it for?
- Ages 14 to 46 years, women onlyHealthy volunteers can take part
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Oct 2013
- 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 14 to 46 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: A multi-ethnic group of pregnant women
Who may be able to join
- all pregnant women
Who cannot join
- known hypersensitivity to influenza vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge Possessed by Pregnant Women Regarding Influenza Vaccination During Pregnancy
Pregnant women have limited knowledge regarding influenza, its implications during pregnancy, and recommendations for vaccination during pregnancy. The researchers plan to distribute an information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits, and then give a questionnaire on the postpartum floor assessing knowledge.
The researchers hypothesize that with education intervention, knowledge scores on the questionnaire will be higher than those from last year, when no education was provided.
- Keywords
- influenza, vaccine, pregnancy
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | All women presenting to our prenatal clinic and postpartum floor during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge scores on our questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2013
- Study completionOct 2013
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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark H Yudin, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593970
- Sponsor's protocol ID
- 06-190 part2
- Status last verified
- Feb 2019
- First submitted
- 3 Jan 2008
- 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
- Knowledge Possessed by Pregnant Women Regarding Influenza Vaccination During Pregnancy
- ClinicalTrials.gov ID
- NCT00593970
- Acronym / sponsor ID
- 06-190 part2
- Keywords
- influenza, vaccine, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jan 2008 (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.
Pregnant women have limited knowledge regarding influenza, its implications during pregnancy, and recommendations for vaccination during pregnancy. The researchers plan to distribute an information pamphlet to women in a prenatal clinic, offer the vaccine during prenatal visits, and then give a questionnaire on the postpartum floor assessing knowledge.
The researchers hypothesize that with education intervention, knowledge scores on the questionnaire will be higher than those from last year, when no education was provided.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –All women presenting to our prenatal clinic and postpartum floor during the study period. |
Who may qualify
- Ages
- 14 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A multi-ethnic group of pregnant women
Key inclusion criteria (1 listed)
- all pregnant women
Key exclusion criteria (1 listed)
- known hypersensitivity to influenza vaccine
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
Knowledge scores on our questionnaire
Time frame: 2 months
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 principal investigator
Unity Health Toronto
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 Pregnancy, 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.
What does the primary outcome measure?
Knowledge scores on our questionnaire (time frame: 2 months). 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 22 Feb 2019.