A Comparison of a Novel Sheathed Speculum to a Standard Speculum for Visualization of the Cervix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Degree of cervix visualized.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Degree of cervix visualized.
时间窗: 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.
次要结局
- Comparison of pain during speculum examination.(During speculum examination.)
研究者
D. Ashley Hill, MD
Associate Director, Department of Obstetrics and Gynecology, Florida Hospital Graduate Medical Education
AdventHealth