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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
  Purpose

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 Intervention
Comparison of a Sheathed Versus Standard Plastic Speculum
Procedure: Sheathed speculum examination
Procedure: Standard speculum examination

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 136
Study Start Date: July 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Florida Hospital

Additional 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
Study First Received: August 7, 2012
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Florida Hospital:
speculum
vagina
cervix
examination

ClinicalTrials.gov processed this record on November 24, 2014