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

Not Applicable

Completed

• Conditions: Comparison of a Sheathed Versus Standard Plastic Speculum
• Interventions: Procedure: Sheathed speculum examination; Procedure: Standard speculum examination

• Registration Number: NCT01670630
• Lead Sponsor: AdventHealth

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-22
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sheathed speculum	Sheathed speculum examination	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.
Standard speculum examination	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.

Primary Outcome Measures

Name	Time	Method
Degree of cervix visualized.	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

Name	Time	Method
Comparison of pain during speculum examination.	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).

Trial Locations

Locations (1)

Loch Haven Ob/Gyn Group; 🇺🇸 Orlando, Florida, United States