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

Hôpital Européen Marseille1,028 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,028

Conditions

Genital Infection Asymptomatic Infections

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bacterial infection detection rates

Bacterial infection detection rates of VSS compared with VCS

Time frame: 10 days

Yeast infection detection rates

Yeast infection detection rates of VSS compared with VCS

Time frame: 10 days

Chlamydia trachomatis detection rates

Chlamydia trachomatis detection rates of VSS compared with VCS

Time frame: 10 days

Neisseria gonorrhoeae detection rates

Neisseria gonorrhoeae detection rates of VSS compared with VCS

Time frame: 10 days

Mycoplasma genitalium detection rates

Mycoplasma genitalium detection rates of VSS compared with VCS

Time frame: 10 days

Trichomonas vaginalis detection rates

Trichomonas vaginalis detection rates of VSS compared with VCS

Time frame: 10 days

Human simplex virus detection rates

Human simplex virus detection rates of VSS compared with VCS

Time frame: 10 days

Group B streptococcus detection rates

Group B streptococcus detection rates of VSS compared with VCS

Time frame: 10 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes