RubellaNCT00401505
Rubella Susceptibility in Multiparous Women
An observational study of Rubella and Vaccine, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the reasons why multiparous women (women who are pregnant and have been pregnant before) might still be susceptible to rubella. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- How many people
- 310 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Sep 2012
- 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: All rubella susceptible women who delivered during the study period.
Who may be able to join
- All rubella susceptible women who delivered during the study period.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the reasons why multiparous women (women who are pregnant and have been pregnant before) might still be susceptible to rubella.
Read the detailed description
This study is designed to investigate why multiparous women might still be susceptible to rubella. All pregnant women are checked for rubella immunity, and if they are non-immune, there are standard orders in our hospital to administer the rubella vaccine on the post-partum floor prior to discharge home from the hospital. Despite this, some multiparous women are found to be susceptible (non-immune), and this study will explore the reasons for this.
- Keywords
- rubella, rubella vaccine, postpartum, immunity
- Medical subject headings
- Rubella
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 startSep 2006
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RubellaStudies 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
- Retrospective
- Enrolment
- 310 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, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401505
- Sponsor's protocol ID
- 06-186
- Status last verified
- Feb 2019
- First submitted
- 17 Nov 2006
- Last updated
- 22 Feb 2019
- Results posted
- 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
- Rubella Susceptibility in Multiparous Women
- ClinicalTrials.gov ID
- NCT00401505
- Acronym / sponsor ID
- 06-186
- Keywords
- rubella, rubella vaccine, postpartum, immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (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 study is to determine the reasons why multiparous women (women who are pregnant and have been pregnant before) might still be susceptible to rubella.
Detailed description
This study is designed to investigate why multiparous women might still be susceptible to rubella. All pregnant women are checked for rubella immunity, and if they are non-immune, there are standard orders in our hospital to administer the rubella vaccine on the post-partum floor prior to discharge home from the hospital. Despite this, some multiparous women are found to be susceptible (non-immune), and this study will explore the reasons for this.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All rubella susceptible women who delivered during the study period.
Key inclusion criteria (1 listed)
- All rubella susceptible women who delivered during the study period.
Key exclusion criteria (0 listed)
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
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 Rubella 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 0 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.