Self-Obtained Transperineal and Transvaginal Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor: Implications for Telemedicine and Home Hospital in Obstetrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.
研究概览
简要总结
This is a pilot study to test the accuracy and comfort of self-directed ultrasound imaging of cervical dilation and effacement in pregnant women undergoing induction of labor. The study will assess correlation of cervical measurements between self-directed imaging and experienced provider digital cervical examinations.
详细描述
The primary objective will assess correlation of cervical measurements with gold standard of provider digital cervical examinations and self-obtained transperineal and transvaginal images. Experienced providers performing digital cervical examinations will be blinded to ultrasound images and measurements. The maternal-fetal medicine subspecialist interpreting the ultrasound images will be blinded to patient details and will document ultrasound measurement of cervical dilation of the internal cervical os as the mean of anterior-posterior and transverse measurements and cervical length. 2-D ultrasound images and cine clips will be obtained at up to five different time points during the induction of labor.
As as secondary objective, participant discomfort and anxiety will be measured following the initial set of cervical measurements using the Visual Analog Scale and Six-Item State-Trait Anxiety Inventory.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant females age 18 years or older
- •Third trimester of pregnancy with a singleton fetus (gestational age >28 weeks)
- •Pre-gestational body mass index <40
- •Scheduled for induction of labor
- •Eligible for induction of labor based on current birth center guidelines
- •Intact membranes when presenting for induction of labor
排除标准
- •History of prior cervical loop electrosurgical excisional procedure or cold knife conization
- •Cerclage placement during current pregnancy
- •Positive COVID-19 test within 7 days of admission for induction of labor
- •Fever > 38.0 C at time of admission for induction of labor
结局指标
主要结局
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.
时间窗: Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months
Data collection will occur at up to five time points along a participant's labor course. Providers will be blinded to ultrasound images. Data includes provider digital exam, transperineal ultrasound cine clip with mean (anterior-posterior and transverse) measurement of internal os and total cervical length and transvaginal ultrasound cine clips with mean (anterior-posterior and transverse) measurement of internal os and total cervical length. Ultrasound images will be read by maternal-fetal medicine subspecialist blinded to patient information, labor stage and provider cervical examination.
次要结局
- Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)(On day of induction after first cervical examination during first assessment, through study completion up to 6 months)
- Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)(On day of induction after first cervical examination during first assessment, through study completion up to 6 months)
研究者
Regan N. Theiler
Associate Professor of Obstetrics and Gynecology
Mayo Clinic