Asymptomatic Infections, Genital Infection
Conditions
Keywords
Vaginal self-sampling, STI, Genital infection, Group B streptococcus
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.
Interventions
PROCEDUREVaginal 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.
Sponsors
Hôpital Européen Marseille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants were screenned for genital infections * performing vaginal and/or cervical classical-sampling (VCS) * performing vaginal self-sampling (VSS)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial infection detection rates | 10 days | Bacterial infection detection rates of VSS compared with VCS |
| 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 |
Countries
France
Outcome results
None listed