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

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ClinicalTrials.gov Identifier: NCT01670630
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : March 4, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Comparison of a Sheathed Versus Standard Plastic Speculum Procedure: Sheathed speculum examination Procedure: Standard speculum examination

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix
Study Start Date : July 2012
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670630


Locations
United States, Florida
Loch Haven Ob/Gyn Group
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital
MDI Worldwide LLC
Investigators
Principal Investigator: David A Hill, M.D. Florida Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: D. Ashley Hill, MD, Associate Director, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education, Florida Hospital
ClinicalTrials.gov Identifier: NCT01670630     History of Changes
Other Study ID Numbers: CS201202
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by D. Ashley Hill, MD, Florida Hospital:
speculum
vagina
cervix
examination