Trial record 1 of 76 for:    pelvic inflammatory disease AND (woman OR women OR female)
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Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease (POPI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by St George's, University of London.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00115388
First received: June 21, 2005
Last updated: May 23, 2008
Last verified: May 2008
  Purpose

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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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


Condition Intervention
Pelvic Inflammatory Disease
Chlamydia Infections
Procedure: Screening for chlamydia using self-taken vaginal swabs

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • Primary outcome measure in the complete cohort: Incidence of clinical PID over 12 months in intervention and control groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures after 12 months in women with chlamydial infection at baseline: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Control group (untreated): [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of PID. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage with spontaneous clearance of genital infection. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Relative risk of PID in women with and without BV [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 3. Intervention group (treated): Reinfection rate. [ Time Frame: 1-3 years ] [ Designated as safety issue: No ]

Enrollment: 2531
Study Start Date: September 2004
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Screening for chlamydia using self-taken vaginal swabs
    Women in the intervention group will be tested for chlamydia and those found to be infected will be referred for treatment and partner notification
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 27 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115388

Locations
United Kingdom
St George's Hospital Medical School
London, United Kingdom, Sw17 ORE
Sponsors and Collaborators
St George's, University of London
Investigators
Principal Investigator: Pippa Oakeshott, MD FRCP St George's, University of London
Study Chair: Phillip Hay, FRCP St George's, University of London
  More Information

No publications provided by St George's, University of London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vasanti Patel, St George's, University of London
ClinicalTrials.gov Identifier: NCT00115388     History of Changes
Other Study ID Numbers: COHSR4PG
Study First Received: June 21, 2005
Last Updated: May 23, 2008
Health Authority: United Kingdom: National Health Service

Keywords provided by St George's, University of London:
Pelvic inflammatory disease
Chlamydia trachomatis
Screening

Additional relevant MeSH terms:
Pelvic Inflammatory Disease
Pelvic Infection
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Adnexal Diseases
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection

ClinicalTrials.gov processed this record on April 23, 2014