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

This study has been completed.
Sponsor:
Collaborator:
MDI Worldwide LLC
Information provided by (Responsible Party):
D. Ashley Hill, MD, Florida Hospital
ClinicalTrials.gov Identifier:
NCT01670630
First received: August 7, 2012
Last updated: February 28, 2013
Last verified: February 2013

August 7, 2012
February 28, 2013
July 2012
February 2013   (final data collection date for primary outcome measure)
Degree of cervix visualized. [ Time Frame: During vaginal speculum examination. ] [ Designated as safety issue: No ]
To compare the degree of cervical visualization as interpreted by the investigator between the sheathed speculum and the standard plastic disposable speculum.
Same as current
Complete list of historical versions of study NCT01670630 on ClinicalTrials.gov Archive Site
Comparison of pain during speculum examination. [ Time Frame: During speculum examination. ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Comparison of a Sheathed Versus Standard Plastic Speculum
  • Procedure: Sheathed speculum examination
    Other Names:
    • speculum
    • sheath
    • ClearSpec
  • Procedure: Standard speculum examination
  • 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.
    Intervention: Procedure: Sheathed speculum examination
  • 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.
    Intervention: Procedure: Standard speculum examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01670630
CS201202
No
D. Ashley Hill, MD, Florida Hospital
Florida Hospital
MDI Worldwide LLC
Principal Investigator: David A Hill, M.D. Florida Hospital
Florida Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP