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OpenTrials
Completed

NCT Number: NCT04039711

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

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.

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Key information

Conditions

Genital Infection Asymptomatic Diseases Asymptomatic Infections Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

European Hospital

Marseille, Bouches-du Rhone, 13003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal self-sampling

Procedure

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.

Primary outcomes

  1. Bacterial infection detection rates

    Time frame: 10 days

    Bacterial infection detection rates of VSS compared with VCS

  2. Yeast infection detection rates

    Time frame: 10 days

    Yeast infection detection rates of VSS compared with VCS

  3. Chlamydia trachomatis detection rates

    Time frame: 10 days

    Chlamydia trachomatis detection rates of VSS compared with VCS

  4. Neisseria gonorrhoeae detection rates

    Time frame: 10 days

    Neisseria gonorrhoeae detection rates of VSS compared with VCS

  5. Mycoplasma genitalium detection rates

    Time frame: 10 days

    Mycoplasma genitalium detection rates of VSS compared with VCS

  6. Trichomonas vaginalis detection rates

    Time frame: 10 days

    Trichomonas vaginalis detection rates of VSS compared with VCS

  7. Human simplex virus detection rates

    Time frame: 10 days

    Human simplex virus detection rates of VSS compared with VCS

  8. Group B streptococcus detection rates

    Time frame: 10 days

    Group B streptococcus detection rates of VSS compared with VCS

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2019
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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