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

Asymptomatic Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039711
• Other study ID #: RCB 2014-A01250-47
• Status: Completed
• Phase: N/A
• Start date: October 20, 2015
• Est. completion date: April 6, 2018

Study information

• Verified date: August 2019
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1028
• Est. completion date: April 6, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Infections
• Communicable Diseases
• Genital Infection
• Infection

Intervention

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.

Locations

Country	Name	City	State
France	European Hospital	Marseille	Bouches-du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

References & Publications (2)

Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, Schachter J, Holmes KK, Martin DH. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexuall — View Citation

Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.137 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial infection detection rates	Bacterial infection detection rates of VSS compared with VCS	10 days
Primary	Yeast infection detection rates	Yeast infection detection rates of VSS compared with VCS	10 days
Primary	Chlamydia trachomatis detection rates	Chlamydia trachomatis detection rates of VSS compared with VCS	10 days
Primary	Neisseria gonorrhoeae detection rates	Neisseria gonorrhoeae detection rates of VSS compared with VCS	10 days
Primary	Mycoplasma genitalium detection rates	Mycoplasma genitalium detection rates of VSS compared with VCS	10 days
Primary	Trichomonas vaginalis detection rates	Trichomonas vaginalis detection rates of VSS compared with VCS	10 days
Primary	Human simplex virus detection rates	Human simplex virus detection rates of VSS compared with VCS	10 days
Primary	Group B streptococcus detection rates	Group B streptococcus detection rates of VSS compared with VCS	10 days