跳至主要内容
临床试验/NCT05260333
NCT05260333已完成不适用

Use of a Pocket-device Point-of-care Ultrasound to Assess Cervical Dilation in Labor: Correlation and Patient Experience

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters

研究概览

简要总结

The primary purpose of this study is to compare the accuracy of the Butterfly iQ pocket ultrasound with the digital cervical examination in the third trimester cervix. The secondary aim of this study is to compare discomfort or the two cervical exam methods and determine if patients have a preference for one over the other.

详细描述

Patients in the 3rd trimester that require a digital cervical exam (DCE) for assessment of labor will be approached. After informed consent is obtained, one of two study investigators will perform a transperineal ultrasound (TPUS) using the glove-covered Butterfly iQ+ probe. The Butterfly iQ+ does not have a transperineal probe or setting, therefore, the "bladder" preset setting will be used. The "bladder" setting has been predetermined to provide the best cervical images. This pocket ultrasound is FDA-approved and is the standard of care for point of care ultrasounds in many institutions and is already used in our department. The TPUS will be performed by 1 of the 2 investigators with digital calipers. There will be 3 measurements: dilation, effacement, and station. The dilation measurements with be made from the inside margins of the cervix . Effacement will be measured by marking the thinnest and most easily imaged lip of the cervix. Zero station will be assumed to be 5 cm above the perineum, with distances from 6-10 cm corresponding to -1 to -5 station clinically. An independent, blinded examiner will then perform a traditional digital cervical exam, which will be recorded in EPIC. The study investigators will be blinded to the DCE measurement until the end of the study. The patient will act as their own control. Additionally, the investigators will collect EGA, race, ethnicity, age, BMI, and indication for assessment of the cervix.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

盲法说明

The investigator will not know the digital cervical exam value.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women in the third trimester presenting for assessment of labor or admitted for labor and delivery.

排除标准

  • Second trimester (less than 28 weeks)
  • Does not wish to participate

结局指标

主要结局

Correlation of Cervical Dilation Via Butterfly iQ Pocket Ultrasound in Centimeters

时间窗: 1 day

Dilation was measured on the day of the exam in centimeters. A correlation coefficient was then calculated to determine the relationship between the two exams.

次要结局

  • Discomfort Scale(1 day)
  • Preference for 1 Exam Over the Other(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Leah Antoniewicz

Assistant Professor

Baylor College of Medicine

研究点 (2)

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