Bacterial Vaginosis Screening at IUD Insertion

Completed

• Conditions: BACTERIAL VAGINOSIS

• Registration Number: NCT00802386
• Lead Sponsor: Unity Health Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Primary Completion: 2009-03
• Study Completion: 2011-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain/cramping	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	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.
Rate of abnormal bleeding	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).
Pelvic infection	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.

Secondary Outcome Measures

Name	Time	Method
Occurence of new onset BV infection	1 month post-IUD insertion	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.

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada