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

Hôpital Européen Marseille

Status: Completed

Conditions: Asymptomatic Infections; Genital Infection

Treatments: Procedure: Vaginal self-sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04039711

RCB 2014-A01250-47

Details and patient eligibility

About

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.

Enrollment: 1,028 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,028 participants in 1 patient group

Genital infections

Other group

Description:

Women with vaginal/cervical sampling indications

Treatment:

Procedure: Vaginal self-sampling