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

AdventHealth

Status: Completed

Conditions: Comparison of a Sheathed Versus Standard Plastic Speculum

Treatments: Procedure: Sheathed speculum examination; Procedure: Standard speculum examination

Study type: Interventional

Funder types: Other

Identifiers

NCT01670630

CS201202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Sheathed speculum

Active Comparator group

Description:

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.

Treatment:

Procedure: Sheathed speculum examination

Standard speculum examination

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard speculum examination