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

Primary Purpose

Genital Infection, Asymptomatic Infections

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vaginal self-sampling
Sponsored by
Hôpital Européen Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Genital Infection focused on measuring Vaginal self-sampling, STI, Genital infection, Group B streptococcus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • European Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Genital infections

Arm Description

Women with vaginal/cervical sampling indications

Outcomes

Primary Outcome Measures

Bacterial infection detection rates
Bacterial infection detection rates of VSS compared with VCS
Yeast infection detection rates
Yeast infection detection rates of VSS compared with VCS
Chlamydia trachomatis detection rates
Chlamydia trachomatis detection rates of VSS compared with VCS
Neisseria gonorrhoeae detection rates
Neisseria gonorrhoeae detection rates of VSS compared with VCS
Mycoplasma genitalium detection rates
Mycoplasma genitalium detection rates of VSS compared with VCS
Trichomonas vaginalis detection rates
Trichomonas vaginalis detection rates of VSS compared with VCS
Human simplex virus detection rates
Human simplex virus detection rates of VSS compared with VCS
Group B streptococcus detection rates
Group B streptococcus detection rates of VSS compared with VCS

Secondary Outcome Measures

Full Information

First Posted
July 29, 2019
Last Updated
August 1, 2019
Sponsor
Hôpital Européen Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04039711
Brief Title
Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections
Official Title
Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2015 (Actual)
Primary Completion Date
April 6, 2018 (Actual)
Study Completion Date
April 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Européen Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Infection, Asymptomatic Infections
Keywords
Vaginal self-sampling, STI, Genital infection, Group B streptococcus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants were screenned for genital infections performing vaginal and/or cervical classical-sampling (VCS) performing vaginal self-sampling (VSS)
Masking
None (Open Label)
Allocation
N/A
Enrollment
1028 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genital infections
Arm Type
Other
Arm Description
Women with vaginal/cervical sampling indications
Intervention Type
Procedure
Intervention Name(s)
Vaginal self-sampling
Intervention Description
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 Outcome Measure Information:
Title
Bacterial infection detection rates
Description
Bacterial infection detection rates of VSS compared with VCS
Time Frame
10 days
Title
Yeast infection detection rates
Description
Yeast infection detection rates of VSS compared with VCS
Time Frame
10 days
Title
Chlamydia trachomatis detection rates
Description
Chlamydia trachomatis detection rates of VSS compared with VCS
Time Frame
10 days
Title
Neisseria gonorrhoeae detection rates
Description
Neisseria gonorrhoeae detection rates of VSS compared with VCS
Time Frame
10 days
Title
Mycoplasma genitalium detection rates
Description
Mycoplasma genitalium detection rates of VSS compared with VCS
Time Frame
10 days
Title
Trichomonas vaginalis detection rates
Description
Trichomonas vaginalis detection rates of VSS compared with VCS
Time Frame
10 days
Title
Human simplex virus detection rates
Description
Human simplex virus detection rates of VSS compared with VCS
Time Frame
10 days
Title
Group B streptococcus detection rates
Description
Group B streptococcus detection rates of VSS compared with VCS
Time Frame
10 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
European Hospital
City
Marseille
State/Province
Bouches-du Rhone
ZIP/Postal Code
13003
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18157061
Citation
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 sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d.
Results Reference
result
PubMed Identifier
26168051
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: 10.1371/journal.pone.0132776. eCollection 2015.
Results Reference
result

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

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