Oakeshott Pippa, Kerry Sally, Atherton Helen, Aghaizu Adamma, Hay Sima, Taylor-Robinson David, Simms Ian, Hay Phillip
Division of Community Health Sciences, St George's, University of London, London, SW17 0RE, UK.
Trials. 2008 Dec 10;9:73. doi: 10.1186/1745-6215-9-73.
Pelvic inflammatory disease (PID) is common and can lead to tubal factor infertility, ectopic pregnancy or chronic pelvic pain. Despite major UK government investment in the National Chlamydia Screening Programme, evidence of benefit remains controversial. The main aim of this trial was to investigate whether screening and treatment of chlamydial infection reduced the incidence of PID over 12 months. Secondary aims were to conduct exploratory studies of the role of bacterial vaginosis (BV) in the development of PID and of the natural history of chlamydial infection.
Randomised controlled trial with follow up after 12 months. SETTING NON-HEALTHCARE: Common rooms and lecture theatres at 20 universities and further education colleges in Greater London.
2500 sexually active female students were asked to complete a questionnaire on sexual health and provide self-administered vaginal swabs and smears.
Vaginal swabs from intervention women were tested for chlamydia by polymerase chain reaction (PCR) and those infected referred for treatment. Vaginal swabs from control women were stored and analysed after a year. Vaginal smears were Gram stained and analysed for BV.
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 three independent researchers blind to whether the woman is in intervention or control group.
Clinical Trials NCT 00115388.
盆腔炎(PID)很常见,可导致输卵管因素不孕、异位妊娠或慢性盆腔疼痛。尽管英国政府在国家衣原体筛查计划上投入了大量资金,但获益证据仍存在争议。本试验的主要目的是调查衣原体感染的筛查和治疗是否能在12个月内降低PID的发病率。次要目的是对细菌性阴道病(BV)在PID发生中的作用以及衣原体感染的自然史进行探索性研究。
12个月后随访的随机对照试验。地点:非医疗机构——大伦敦地区20所大学和继续教育学院的公共活动室和讲堂。
2500名性活跃女学生被要求完成一份性健康问卷,并自行提供阴道拭子和涂片。
对干预组女性的阴道拭子进行聚合酶链反应(PCR)衣原体检测,对感染者进行转诊治疗。对照组女性的阴道拭子保存一年后进行分析。阴道涂片进行革兰氏染色并分析是否存在BV。
干预组和对照组12个月内临床PID的发病率。可能的PID病例将通过问卷和记录检索来确定。由三位独立研究人员对病历进行详细审查以确诊,研究人员不知道该女性属于干预组还是对照组。
临床试验编号NCT 00115388。