Pelvic Inflammatory Disease Clinical Trial
— POPIOfficial title:
Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease
Chlamydial infection is a common, sexually transmitted disease which women can have without
knowing. Untreated, it can lead to an infection of the womb and fallopian tubes called
pelvic inflammatory disease (PID), which can cause infertility. There has been only one
trial of chlamydia screening and this was in American women in 1992 and used outdated tests.
We now need to see if screening using modern tests and self-taken swabs works in a high
risk, young, multiethnic female population in the United Kingdom (UK).
The study is a randomised trial. It will involve asking women students in college bars to
complete confidential questionnaires on sexual health and to provide self-administered
vaginal swabs. We have successfully done this in a small pilot study. Participants will be
told that the tests are for research purposes only and that if they think they may have been
at risk of a sexually transmitted infection they should get checked at a clinic. If the
trial shows that chlamydia screening using these new methods prevents PID, extending this
community-based intervention nationwide could improve women's reproductive health and
wellbeing and might prevent some women from becoming infertile
Status | Completed |
Enrollment | 2531 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 27 Years |
Eligibility |
Inclusion Criteria: - Sexually active Exclusion Criteria: - Never been sexually active - Tested for chlamydia in past 3 months and no new sexual partner since then - Pregnant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | St George's Hospital Medical School | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups. | 12 months | No | |
Secondary | Secondary outcome measures after 12 months in women with chlamydial infection at baseline: | 12 months | No | |
Secondary | Control group (untreated): | 12 months | No | |
Secondary | Incidence of PID. | 12 months | No | |
Secondary | Percentage with spontaneous clearance of genital infection. | 12 months | No | |
Secondary | Relative risk of PID in women with and without BV | 12 months | No | |
Secondary | 3. Intervention group (treated): Reinfection rate. | 1-3 years | No |
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