Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00115388
Other study ID # COHSR4PG
Secondary ID
Status Completed
Phase N/A
First received June 21, 2005
Last updated November 21, 2014
Start date September 2004
Est. completion date December 2008

Study information

Verified date November 2014
Source St George's, University of London
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

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 There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests.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


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom St George's Hospital Medical School London

Sponsors (1)

Lead Sponsor Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT04723069 - Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases Phase 2
Recruiting NCT03391440 - A Trial to Assess the Efficacy and Safety of Morinidazole in Women With Pelvic Inflammatory Disease Phase 4
Completed NCT01671280 - Drug Use Investigation Of Azithromycin IV For Community-Acquired Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan) N/A
Not yet recruiting NCT02972151 - Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae Phase 2
Completed NCT01160640 - The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID) Phase 2
Completed NCT01236131 - The Role of Novel Organisms in Acute Endometritis N/A
Active, not recruiting NCT03994055 - Effect of an Anti-inflammatory Diet on Patients With Cervical Cancer N/A
Completed NCT00871494 - Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan Phase 3
Completed NCT00783419 - Rate of Pelvic Inflammatory Disease at St. Michael's Hospital
Completed NCT01799356 - Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials Phase 4
Recruiting NCT05408624 - Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses
Completed NCT01241110 - To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment Phase 4
Completed NCT00453349 - A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease Phase 3
Recruiting NCT04234945 - Effect of Prophylactic Antibiotics for Hysterosalpingography on Post Procedure Morbidity N/A
Recruiting NCT06360965 - Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain N/A
Recruiting NCT05648747 - Pelvic Inflammatory Disease in COVID-19 Era
Completed NCT01793584 - Surgical Success After Laparoscopic vs Abdominal Hysterectomy N/A
Completed NCT01299259 - Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease N/A
Completed NCT03054402 - First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845 Phase 1
Active, not recruiting NCT03828994 - Technology Based Community Health Nursing(TECH-N) to Prevent Recurrent STIs After PID II N/A