Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections

Study Overview
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Brief Summary
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Screening for genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Vaginal self-sampling (VSS) has progressively emerged as an alternative to VCS for STI agent screening. The use of vaginal self-sampling (VSS) could facilitate follow-ups and potentially help in the prevention of gynaecological disorders.

Official Title
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Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial

Conditions
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Genital Infection, Asymptomatic Infections

Intervention / Treatment
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* Procedure: Vaginal self-sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women requiring vaginal or cervical classical sampling to screen for genital infections Women requiring vaginal or cervical classical sampling to screen for sexually transmitted infections (STI) Pregnant women requiring vaginal classical sampling to screeen for Group B streptococcus asymptomatic carriage in the eighth month of pregnancy Informed written consent from the patient Exclusion Criteria: Person subjected to therapeutic limitation decision Women with intact hymen Active antibiotic or antifungic treatment Antiobiotic or antifungic treatment during the 10 days prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Participants were screenned for genital infections performing vaginal and/or cervical classical-sampling (VCS) performing vaginal self-sampling (VSS)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Genital infections<br>Women with vaginal/cervical sampling indications | Procedure: Vaginal self-sampling<br>* The objective is to determine the non-inferiority of vaginal self-sampling compared with vaginal/cervical classical sampling, and evaluate the possibility of using it in all clinical situations indicating the prescription of such a procedure to screen for genital infections (GIs), sexually transmitted infections (STIs) and group B streptococcus (GBS) asymptomatic carriage in pregnant women.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial infection detection rates | Bacterial infection detection rates of VSS compared with VCS | 10 days | 
| Yeast infection detection rates | Yeast infection detection rates of VSS compared with VCS | 10 days | 
| Chlamydia trachomatis detection rates | Chlamydia trachomatis detection rates of VSS compared with VCS | 10 days | 
| Neisseria gonorrhoeae detection rates | Neisseria gonorrhoeae detection rates of VSS compared with VCS | 10 days | 
| Mycoplasma genitalium detection rates | Mycoplasma genitalium detection rates of VSS compared with VCS | 10 days | 
| Trichomonas vaginalis detection rates | Trichomonas vaginalis detection rates of VSS compared with VCS | 10 days | 
| Human simplex virus detection rates | Human simplex virus detection rates of VSS compared with VCS | 10 days | 
| Group B streptococcus detection rates | Group B streptococcus detection rates of VSS compared with VCS | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal self-sampling, STI, Genital infection, Group B streptococcus