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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-05

Study Completion Date

2023-02-21

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Mycoplasma Genitalium Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vaginal self-sampling

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

Group Type EXPERIMENTAL

Vaginal self-sampling

Intervention Type OTHER

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

Interventions

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Vaginal self-sampling

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No