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

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

1028 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-20

Study Completion Date

2018-04-06

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.

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Detailed Description

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Conditions

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Genital Infection Asymptomatic Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants were screenned for genital infections

* performing vaginal and/or cervical classical-sampling (VCS)
* performing vaginal self-sampling (VSS)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Genital infections

Women with vaginal/cervical sampling indications

Group Type OTHER

Vaginal self-sampling

Intervention Type PROCEDURE

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.

Interventions

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Vaginal self-sampling

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No