Pelvic Inflammatory Disease Clinical Trial
Official 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trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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
Background: Pelvic inflammatory disease (PID) is common and can lead to infertility, ectopic
pregnancy or chronic pelvic pain.
Objectives: To see if screening and treatment of chlamydial infection reduces the incidence
of PID over 12 months, and to investigate the natural history of chlamydial infection and
the role of bacterial vaginosis (BV) in the development of chlamydia associated PID.
Design: Randomised trial over one year
Setting: Common rooms, bars and lecture theatres at universities and colleges in London, UK.
Participants: 2500 sexually active female students aged <28 years will be asked to complete
a questionnaire on sexual health and to provide a self-administered vaginal swab and smear
with follow up after a year.
Intervention: Following randomisation, vaginal swabs from intervention women will be tested
for chlamydia by PCR and those infected referred for treatment. Vaginal swabs from control
women will be stored and analysed after a year. Vaginal smears will be Gram stained and
analysed for BV.
Main outcome measure: Incidence of clinical PID over 12 months in intervention and control
groups.
Possible cases of PID will be identified from questionnaires and record searches.
Confirmation of the diagnosis will be done by detailed review of medical records by two
independent researchers blind to whether the woman is in the intervention or control group.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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