Loch Haven Ob/Gyn Group
Orlando, Florida, 32804, United States
Completed
NCT Number: NCT01670630
A Comparison of a Sheathed 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.
Completed
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Notify MeKey information
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sheathed speculum examination
ProcedureOther names: speculum, sheath, ClearSpec
Standard speculum examination
ProcedurePrimary outcomes
-
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 outcomes
-
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).
Sponsors and collaborators
Lead sponsor
AdventHealth
Other
Collaborators
- MDI Worldwide LLC
Registry information
Official study title
A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Aug 22, 2012
- Registry last updated
- Mar 4, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.