A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix

February 28, 2013 updated by: D. Ashley Hill, MD, AdventHealth

A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix

The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.

Study Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

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

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Loch Haven Ob/Gyn Group

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

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Undergoing clinically indicated vaginal speculum examination.
  • Subject has had at least 1 prior vaginal deliver > 20 weeks gestational age.
  • Able to read and speak English.

Exclusion Criteria:

  • Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia, candida, vaginitis, or vulvar dermatologic condition).
  • Menopausal or using hormone replacement therapy.
  • Genital atrophy.
  • Chronic pelvic pain, dyspareunia, or interstitial cystitis.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sheathed speculum
Investigators will perform a vaginal speculum examination with either a sheathed or a standard ("non sheathed" speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.
Procedure: Sheathed speculum examination
Other Names:
  • speculum
  • sheath
  • ClearSpec
Active Comparator: Standard speculum examination
Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.
Procedure: Standard speculum examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of cervix visualized.
Time Frame: During vaginal speculum examination.
To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.
During vaginal speculum examination.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pain during speculum examination.
Time Frame: During speculum examination.
To compare the subjects' comfort level between the sheathed and standard speculums when undergoing a vaginal speculum examination, using a patient-reported 10-cm visual analog scale (VAS).
During speculum examination.

Collaborators and Investigators

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

Sponsor

AdventHealth

Collaborators

MDI Worldwide LLC

Investigators

  • Principal Investigator: David A Hill, M.D., AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

March 4, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS201202

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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