Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium

University Hospital, Bordeaux69 enrolled

Overview

It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium. The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium

Mycoplasma genitalium is a bacterium that colonizes female genital tract and can be responsible for sexually transmitted infection . M. genitalium can cause cervicitis and more rarely high genital infections. In the vast majority of cases, presence of M. genitalium is not accompanied by any symptoms and women do not develop disease. Natural history of M. genitalium infection is not well documented. Some studies have shown a natural clearance of infection in women. The published work mainly concerns patients at very high risk of sexually transmitted disease, but we do not have French data. We propose to study the natural clearance of M. genitalium infection in patients consulting at the Orthogeny Centre of the University Hospital of Bordeaux. Results of this work will allow us to have a better knowledge of the natural history of M. genitalium infection.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Mycoplasma Genitalium Infection

Interventions

Vaginal self-samplingOTHER

Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient selected during the first consultation, pre-abortion, and having a vaginal swab positive to M. genitalium. * Patient hospitalized for an abortion at the University Hospital of Bordeaux. * An affiliated patient or beneficiary of a social security system. * Signing free and informed consent. Exclusion criteria: * Patient with vaginal co-infection with C. trachomatis. * Patient with symptoms of high genital infection. * Taking fluoroquinolones, macrolides or tetracyclines within 21 days of inclusion. * Patient under legal protection.

Locations (1)

CHU Bordeaux

Bordeaux, France

Outcomes

Primary Outcomes

clearance at week 3

The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.

Time frame: Week 3

Secondary Outcomes

clearance at week 9

The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 9.

Time frame: Week 9

Prevalence of N. gonorrhoeae infections

Prevalence of infections with N. gonorrhoeae calculated by making the ratio between the number of patients with a positive vaginal swab for N. gonorrhoeae compared to the total number of patients tested.

Time frame: Week 3, Week 9

Prevalence of C. trachomatis infections

Prevalence of infections with C. trachomatis calculated by making the ratio between the number of patients with a positive vaginal swab for C. trachomatis compared to the total number of patients tested.

Time frame: Week 3, Week 9

Prevalence of M. genitalium infections

Prevalence of infections with M. genitalium, calculated by making the ratio between the number of patients with a positive vaginal swab for M. genitalium compared to the total number of patients tested.

Time frame: Week 3, Week 9

patient's sex life

patient's sex life, assessed by a self-questionnaire

Time frame: Week 3, Week 9

Data from ClinicalTrials.gov

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