NCT04039711

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,028 (actual)
• Sponsor: Hôpital Européen Marseille · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Genital Infection
• Asymptomatic Infections

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2015-10-20
• Primary completion: 2018-04-06
• Completion: 2018-04-06
• First posted: 2019-07-31
• Last updated: 2019-08-02

Locations

1 site across 1 country: France