Infectious Risk of Vaginal Ultrasound Examination: Evaluation and Modeling From Human Papillomavirus (HPV) (PREEV)

March 21, 2022 updated by: Assistance Publique - Hôpitaux de Paris
Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination and probe disinfection. This will allow modeling the risk of HPV transmission, and could contribute establishing future guidelines for reducing the risk of transmission of microorganisms and the risk of infection through TVS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Prevention of infection Endo Vaginal sonography. Brief Summary

Background Trans vaginal sonography (TVS) is widely used in obstetrics and gynecology. Because of the relative lack of data, there is no universal agreement on how to prevent the transmission of pathogens and the risk of infection through TVS. Whereas American guideline are more stringent, French health authorities recommend low-level disinfection of the probe between two patients with the use of probe cover, and intermediate level disinfection at least once daily and in case of visible contamination of the probe, or rupture of the probe cover. For the coupling gel, guidelines do not agree on whether or not it should be sterile.

Transmitting infectious agents may result from a variety of causes: failure to disinfect the probe, contaminated gel, contamination of the probe cover due to incorrect manipulation and failure to comply with hand washing or disinfection.

Due to resistance to disinfection, high prevalence, and potential oncogenic role, we will use HPV as a marker for the presence of pathogens on the probe, the probe cover, and the environment.

Objectives Primary objective: to assess the presence of HPV on bare probes and on probes with their probe-cover in routine practice

Secondary objectives:

  1. - To assess compliance to guidelines of prevention of pathogens
  2. - To identify factors associated with the presence of HPV on the probe

2a Factors related to the procedure Compliance to disinfection guidelines prior to performing TVS Rank of procedure since last daily midlevel disinfection Presence of HPV on the ultrasound machine key board, a proxy of the environment 2b Factors related to the center in which TVS is performed Compliance to daily disinfection guidelines Traceability of the disinfection processes Type of center (emergency clinic /planned sessions / obstetrics / gynecology /IVF monitoring) 3 - To estimate the incidence of probe cover rupture and of visible probe contamination by bodily fluids 4 - To model the cost effectiveness of strategies of disinfection

Methods Type of study: observational survey

Main outcome criterion:

Percentage and 95 % confidence interval of TVS procedure

  • with bare probe positive for HPV
  • with covered probe positive for HPV Statistical unit: each procedure surveyed Viral assays HPV DNA detection will be performed on all samples (keyboard, bare and covered probe) using the cobas® HPV Test Kit (Roche): This test allows to detect the presence of cellular DNA and DNA of 14 high-risk HPV (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) and to specifically identify the presence of HPV16 and 18. In case of positive result for both bare and covered probe, a detection of HPV complete episomal genome will be performed, and circular HPV DNA will be amplified using a polymerase whch selectively amplifies circular double-stranded DNA with specific degenerate HPV primers. The amplicons will then be sequenced using specific HPV primers GP5 + / GP6 + (MARINCEVIC Y-Zuniga et al, 2012, Virology).

Secondary outcome criteria Percentage of procedures with keyboard positive for HPV Percentage of procedures with visible rupture of probe cover Percentage of procedures with visibly tainted probes Percentage of procedures with visible rupture of probe cover during previous procedure Percentage of procedures with visibly tainted probes during previous procedure Percentage of presence of each disinfection guideline item since last procedure and before the probe is tested for the presence of HPV Percentage of centers with a written protocol complying with disinfection guidelines Percentage of centers with traceability of disinfection procedures.

Number of observations: 1000 TVS procedures

Inclusion criterion: Any TVS performed in a participating center during an observation session Exclusion criteria: TVS with invasive procedure. Patient refusal Center selection: private and public centers from the Ile de France region, performing TVS routinely, who volunteered to enroll.

Perspectives Evaluating the presence of HPV on TVS probes in relation with the actual behavior of professionals in routine practice will help us modeling the risk of transmitting pathogens during TVS and may contribute to establishing prevention guidelines

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hopital La Pitié Salpêtrire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women who will have an examination of endo-vaginal ultrasound

Description

Inclusion Criteria:

  • All examination of endo-vaginal ultrasound performed at participating center during a predetermined observation session,

Exclusion Criteria:

  • * Endo-Vaginal ultrasound with invasive procedure (with cutaneous or mucosal break)

    • Refusal of the patient that non-personal data are addressed in a study,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage and 95 % confidence interval of TVS procedures with bare probe positive for HPV
Time Frame: 12 months
Qualitative variable. Statistical unit: each procedure surveyed
12 months
Percentage and 95 % confidence interval of TVS procedures with covered probe positive for HPV
Time Frame: 12 months
Qualitative variable. Statistical unit: each procedure surveyed
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of procedures with keyboard positive for HPV
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit: each procedure surveyed. In addition, the number of disinfection items present will be added as a score.
12 months
Percentage of procedures with visible rupture of probe cover
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit: each procedure surveyed. In addition, the number of disinfection items present will be added as a score.
12 months
Percentage of procedures with visibly tainted probes
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit:
12 months
Percentage of procedures with visible rupture of probe cover during previous procedure
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit:
12 months
Percentage of procedures with visibly tainted probes during previous procedure
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit:
12 months
Percentage of presence of each disinfection guideline item since last procedure and before the probe is tested for the presence of HPV
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit:
12 months
Percentage of centers with a written protocol complying with disinfection guidelines
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit:
12 months
percentage of centers with traceability of disinfection procedures.
Time Frame: 12 months
Qualitative variables will be analyzed as percentages of presence. Statistical unit:
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Christophe LUCET, PHD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NI14013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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