CompletedNot Applicable

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

United States136 participantsStarted 2012-07

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Degree of cervix visualized.

Timeframe: During vaginal speculum examination.

Trial details

NCT IDNCT01670630

SponsorAdventHealth

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-02

View on ClinicalTrials.gov More Comparison of a Sheathed Versus Standard Plastic Speculum trials