Clinical trial NCT04841408: Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium
Official title: Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycoplasma Genitalium Infection
Keywords: Mycoplasma genitalium
abortion
clearance
IST
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks
Primary purpose: OTHER

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: clearance at week 3
timeFrame: Week 3
Secondary outcomes:
measure: clearance at week 9
timeFrame: Week 9
measure: Prevalence of N. gonorrhoeae infections
timeFrame: Week 3, Week 9
measure: Prevalence of C. trachomatis infections
timeFrame: Week 3, Week 9
measure: Prevalence of M. genitalium infections
timeFrame: Week 3, Week 9
measure: patient's sex life
timeFrame: Week 3, Week 9
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References: