Bacterial Vaginosis Screening at IUD Insertion

BACTERIAL VAGINOSIS Clinical Trial

Official title:

Screening for Bacterial Vaginosis Screening at IUD Insertion: Is There a Role?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802386
• Other study ID #: 07-358
• Status: Completed
• Start date: January 2008
• Est. completion date: May 2011

Study information

• Verified date: February 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• pregnancy

• a previous history of ectopic pregnancy or pelvic inflammatory disease

• HIV positive or immunocompromised

• unable to understand English

• unable to give informed consent

Related Conditions & MeSH terms

• BACTERIAL VAGINOSIS
• Vaginal Diseases
• Vaginosis, Bacterial

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month
Primary	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.	1 month
Primary	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.	1 month
Primary	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.	1 month
Secondary	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.	1 month post-IUD insertion