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Bacterial Vaginosis Screening at IUD Insertion
This study is currently recruiting participants.
Verified by St. Michael's Hospital, Toronto, December 2008
Sponsored by: St. Michael's Hospital, Toronto
Information provided by: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00802386
  Purpose

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.


Condition
Bacterial Vaginosis

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Screening for Bacterial Vaginosis Screening at IUD Insertion: Is There a Role?

Further study details as provided by St. Michael's Hospital, Toronto:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

WHOLE BLOOD; VAGINAL SWAB


Estimated Enrollment: 70
Study Start Date: January 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802386

Contacts
Contact: Mark Yudin, MD 416-864-6060 ext 6511 YudinM@smh.toronto.on.ca
Contact: Leanne R De Souza, MSc 416-864-6060 ext 8047 DeSouzaL@smh.toronto.on.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Mark Yudin, MD     416-864-6060 ext 6511     YudinM@smh.toronto.on.ca    
Contact: Leanne R De Souza, MSc     416-864-6060 ext 8047     DeSouzaL@smh.toronto.on.ca    
Principal Investigator: Mark Yudin, MD            
Sponsors and Collaborators
St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital ( Dr. Mark Yudin )
Study ID Numbers: REB 07-358
Study First Received: December 3, 2008
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00802386  
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
BACTERIAL VAGINOSIS
IUD INSERTION

Study placed in the following topic categories:
Genital Diseases, Female
Bacterial Infections
Vaginosis, Bacterial
Vaginitis
Vaginal Diseases

ClinicalTrials.gov processed this record on January 16, 2009