Bacterial Vaginosis Screening at IUD Insertion

February 20, 2019 updated by: Unity Health Toronto

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.

Study Overview

Status

Completed

Conditions

BACTERIAL VAGINOSIS

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5B1W8
    - St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 month
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.	1 month
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.	1 month
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 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of new onset BV infection Time Frame: 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.	1 month post-IUD insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria