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

Not Applicable

Completed

• Conditions: Genital Infection; Asymptomatic Infections
• Interventions: Procedure: Vaginal self-sampling

• Registration Number: NCT04039711
• Lead Sponsor: Hôpital Européen Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-20
• Primary Completion: 2018-04-06
• Study Completion: 2018-04-06
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1028

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genital infections	Vaginal self-sampling	Women with vaginal/cervical sampling indications

Primary Outcome Measures

Name	Time	Method
Yeast infection detection rates	10 days	Yeast infection detection rates of VSS compared with VCS
Chlamydia trachomatis detection rates	10 days	Chlamydia trachomatis detection rates of VSS compared with VCS
Neisseria gonorrhoeae detection rates	10 days	Neisseria gonorrhoeae detection rates of VSS compared with VCS
Mycoplasma genitalium detection rates	10 days	Mycoplasma genitalium detection rates of VSS compared with VCS
Trichomonas vaginalis detection rates	10 days	Trichomonas vaginalis detection rates of VSS compared with VCS
Human simplex virus detection rates	10 days	Human simplex virus detection rates of VSS compared with VCS
Group B streptococcus detection rates	10 days	Group B streptococcus detection rates of VSS compared with VCS
Bacterial infection detection rates	10 days	Bacterial infection detection rates of VSS compared with VCS

Trial Locations

Locations (1)

European Hospital; 🇫🇷 Marseille, Bouches-du Rhone, France