NCT04039711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,028

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

2.5 years

First QC Date

July 29, 2019

Last Update Submit

August 1, 2019

Conditions

Genital InfectionAsymptomatic Infections

Keywords

Vaginal self-samplingSTIGenital infectionGroup B streptococcus

Outcome Measures

Primary Outcomes (8)

  • Bacterial infection detection rates

    Bacterial infection detection rates of VSS compared with VCS

    10 days

  • Yeast infection detection rates

    Yeast infection detection rates of VSS compared with VCS

    10 days

  • Chlamydia trachomatis detection rates

    Chlamydia trachomatis detection rates of VSS compared with VCS

    10 days

  • Neisseria gonorrhoeae detection rates

    Neisseria gonorrhoeae detection rates of VSS compared with VCS

    10 days

  • Mycoplasma genitalium detection rates

    Mycoplasma genitalium detection rates of VSS compared with VCS

    10 days

  • Trichomonas vaginalis detection rates

    Trichomonas vaginalis detection rates of VSS compared with VCS

    10 days

  • Human simplex virus detection rates

    Human simplex virus detection rates of VSS compared with VCS

    10 days

  • Group B streptococcus detection rates

    Group B streptococcus detection rates of VSS compared with VCS

    10 days

Study Arms (1)

Genital infections

OTHER

Women with vaginal/cervical sampling indications

Procedure: Vaginal self-sampling

Interventions

Vaginal self-samplingPROCEDURE

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.

Genital infections

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Person subjected to therapeutic limitation decision
  • Women with intact hymen
  • Active antibiotic or antifungic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital

Marseille, Bouches-du Rhone, 13003, France

Location

Related 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 sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d.

    PMID: 18157061RESULT

  • 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.

    PMID: 26168051RESULT

MeSH Terms

Conditions

Asymptomatic InfectionsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

InfectionsAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCommunicable DiseasesGenital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Participants were screenned for genital infections * performing vaginal and/or cervical classical-sampling (VCS) * performing vaginal self-sampling (VSS)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

October 20, 2015

Primary Completion

April 6, 2018

Study Completion

April 6, 2018

Last Updated

August 2, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)