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OpenTrials
Completed

NCT Number: NCT00802386

Bacterial Vaginosis Screening at IUD Insertion

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Dec 4, 2008
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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