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

Study Overview
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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

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.

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

Conditions
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Mycoplasma Genitalium Infection

Intervention / Treatment
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* Other: Vaginal self-sampling


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal self-sampling<br>Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks. | Other: Vaginal self-sampling<br>* Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance at week 9 | The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 9. | 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. | 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. | 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. | Week 3, Week 9 | 
| patient's sex life | patient's sex life, assessed by a self-questionnaire | Week 3, Week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycoplasma genitalium, abortion, clearance, IST