BACTERIAL VAGINOSISNCT00802386
Bacterial Vaginosis Screening at IUD Insertion
An observational study of BACTERIAL VAGINOSIS, run by Unity Health Toronto at 1 site in Canada.
Trial summary
A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- BACTERIAL VAGINOSIS
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to May 2011
- 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 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.
Who may be able to join
- Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.
Who cannot join
- pregnancy
- a previous history of ectopic pregnancy or pelvic inflammatory disease
- HIV positive or immunocompromised
- unable to understand English
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Bacterial Vaginosis Screening at IUD Insertion: Is There a Role?
A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no inference can be made about the possible influence of IUD insertion and presence to the development of upper genital tract infection . Consequently, with the current literature, it would be difficult to make an argument for screening and treatment for BV prior to IUD insertion. This study will help us determine whether women with an IUD develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In addition, in those women with BV, we are looking to see if they develop more significant problems with the IUD, than those who do not have BV. Overall, this will help us determine whether all women should be screened for BV prior to IUD insertion.
- Conditions
- BACTERIAL VAGINOSIS
- Keywords
- BACTERIAL VAGINOSIS, IUD INSERTION
- Medical subject headings
- Vaginosis, Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of abnormal bleeding
In the study population, we will calculate the number of women who have BV at the time of IUD insertion. In order to assess abnormal bleeding, participants will be asked to keep a menstrual calendar denoting the bleeding characteristics (heavy, normal, light flow or spotting).
Measured: 1 month
Pain/cramping
Participants will be asked to monitor for any signs or symptoms of infection, such as pelvic pain, foul purulent discharge or fever > 38oC.
Measured: 1 month
Expulsion
At the 1-month follow-up visit, repeat swabs for BV will be taken and we will also checking that the IUD is still in place, by the presence of visible IUD strings at the cervical os.
Measured: 1 month
Pelvic infection
Participants will be asked to monitor for any signs or symptoms of infection, such as pelvic pain, foul purulent discharge or fever > 38oC.
Measured: 1 month
Secondary outcomes (1)
Occurence of new onset BV infection
We will look at women who did not have BV at the first visit but who acquire this infection at the 1-month visit. From this, we may make an inference about the possible influence of IUD insertion and presence on the occurrence of vaginal flora changes.
Measured: 1 month post-IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BACTERIAL VAGINOSISStudies of the same condition, open and under way.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802386
- Sponsor's protocol ID
- 07-358
- Status last verified
- Feb 2019
- First submitted
- 3 Dec 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
- Screening for Bacterial Vaginosis Screening at IUD Insertion: Is There a Role?
- ClinicalTrials.gov ID
- NCT00802386
- Acronym / sponsor ID
- 07-358
- Conditions
- BACTERIAL VAGINOSIS
- Keywords
- BACTERIAL VAGINOSIS, IUD INSERTION
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Dec 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.
A number of studies have shown a higher prevalence of BV among IUD users.13,,14 None, however, have screened women prior to inserting the IUD. No data exists detailing the status of the vaginal microflora and possible cervical infection prior to IUD insertion. Thus, no inference can be made about the possible influence of IUD insertion and presence to the development of upper genital tract infection . Consequently, with the current literature, it would be difficult to make an argument for screening and treatment for BV prior to IUD insertion. This study will help us determine whether women with an IUD develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (BV). In addition, in those women with BV, we are looking to see if they develop more significant problems with the IUD, than those who do not have BV. Overall, this will help us determine whether all women should be screened for BV prior to IUD insertion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.
Key inclusion criteria (1 listed)
- Women between the ages of 18 and 48, who request to have an IUD inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study.
Key exclusion criteria (5 listed)
- pregnancy
- a previous history of ectopic pregnancy or pelvic inflammatory disease
- HIV positive or immunocompromised
- unable to understand English
- unable to give informed consent
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
Rate of abnormal bleeding
Time frame: 1 month
In the study population, we will calculate the number of women who have BV at the time of IUD insertion. In order to assess abnormal bleeding, participants will be asked to keep a menstrual calendar denoting the bleeding characteristics (heavy, normal, light flow or spotting).
Pain/cramping
Time frame: 1 month
Participants will be asked to monitor for any signs or symptoms of infection, such as pelvic pain, foul purulent discharge or fever > 38oC.
Expulsion
Time frame: 1 month
At the 1-month follow-up visit, repeat swabs for BV will be taken and we will also checking that the IUD is still in place, by the presence of visible IUD strings at the cervical os.
Pelvic infection
Time frame: 1 month
Participants will be asked to monitor for any signs or symptoms of infection, such as pelvic pain, foul purulent discharge or fever > 38oC.
1 secondary outcome
Occurence of new onset BV infection
Time frame: 1 month post-IUD insertion
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.
The record lists no contact. Use the official record to reach the sponsor.
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 BACTERIAL VAGINOSIS, 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 5 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?
Rate of abnormal bleeding (time frame: 1 month). The study lists 4 primary outcomes in all. 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.