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临床试验/NCT00115388
NCT00115388已完成不适用

Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease

St George's, University of London2 个研究点 分布在 1 个国家目标入组 2,531 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,531
试验地点
2
主要终点
Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.

研究概览

简要总结

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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 27 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Sexually active

排除标准

  • Never been sexually active
  • Tested for chlamydia in past 3 months and no new sexual partner since then

结局指标

主要结局

Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups.

时间窗: 12 months

次要结局

  • 3. Intervention group (treated): Reinfection rate.(1-3 years)
  • Secondary outcome measures after 12 months in women with chlamydial infection at baseline:(12 months)
  • Control group (untreated):(12 months)
  • Incidence of PID.(12 months)
  • Percentage with spontaneous clearance of genital infection.(12 months)
  • Relative risk of PID in women with and without BV(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Pippa Oakeshott

Professor of General Practice

St George's, University of London

研究点 (2)

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