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临床试验/NCT03446248
NCT03446248终止不适用

Mobile Phone Application Versus Artificial Larynx for the Purpose of Vibroacoustic Stimulation in Fetal Non-stress Testing

Wayne State University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
2
主要终点
Fetal heart rate accelerations

研究概览

简要总结

This is a randomized controlled single blinded crossover study to compare fetal vibroacoustic stimulation with a handheld device to a mobile phone application designed for this study. The handheld device, the Corometrics model 146, was previously marketed and sold for fetal stimulation and is modeled after devices used as artificial larynxes. The mobile phone application uses an iPhone's built in vibration with acoustic stimulation from the speaker at 2,000 Hz frequency at a sound level of 74 decibels when measured at 1 meter distance. The investigators' hypothesis is that the mobile phone application will elicit a fetal response (defined as one or more fetal heart rate accelerations in 15 minutes) at a similar rate to that of the handheld device.

Fetal vibroacoustic stimulation is commonly used during antenatal tests of fetal well being such as a non-stress test. Fetal vibroacoustic stimulation works by arousing the fetus to a state of wakefulness during which reassuring fetal movements and associated fetal heart rate accelerations occur. During a non-stress test, two or more fetal heart rate accelerations in 20 minutes constitutes a reassuring test. Fetal vibroacoustic stimulation has been shown to decrease the false positive rate of non-stress testing without increasing the false negative rate. This study will compare the frequency that one or more fetal heart rate accelerations occur in the 15 minutes after vibroacoustic stimulation with the Corometrics-146 fetal acoustic stimulator compared to after vibroacoustic stimulation with a mobile phone application designed for the study.

详细描述

There are multiple proposed methods of assessing fetal well-being in utero. One such method which has been well accepted for fetal surveillance is the non-stress test (NST), during which the fetal heart rate is monitored with cardiotocography for a period of 20-40 minutes, depending on the time it takes to confirm reactivity. Reactivity is confirmed when there is an increase in fetal heart rate, called an acceleration, the presence of which has been shown to reliably predict the absence of fetal metabolic acidemia. Non-stress testing assumes that with fetal movements, a nonacidotic, neurologically normal fetus will have an acceleration. Fetuses develop reactive tracings between 28 and 32 weeks, with 80% of normally developed fetuses displaying reactive fetal heart rate tracings by 32 weeks.

Two limitations to fetal non-stress testing have been recognized. Due to fetal sleeping periods during which movement is decreased, tests may be falsely interpreted as non-reactive, which can lead to unnecessary intervention such as prolonged monitoring, additional testing such as the biophysical profile, induction of labor, or delivery by cesarean section. In addition, if a tracing is not found to be reactive after 20 minutes, extending the testing time to 40 minutes may eventually produce a reactive tracing. This, however, is taxing on antepartum unit equipment, staff resources, and can create additional patient anxiety.

Vibroacoustic stimulation (VAS) is a method used to arouse the fetus from a state of fetal sleep to fetal activity, reflected as an increased heart rate, called an acceleration, on electronic fetal monitoring. Until now, VAS has been emitted from an artificial larynx called a vibroacoustic stimulator which is held on or above the pregnant woman's abdomen to transmit audible frequency to the fetus. For example, one such device, the Corometrics-146, sends out a vibratory sound stimulus with a frequency of approximately 75 Hz and an intensity of approximately 74db for a duration of 3 seconds. A recent Cochrane Review concluded that the use of VAS in antenatal testing reduced both incidence of non-reactive fetal heart rate tracing and overall testing time. This has implications for clinical use, allowing equipment and staff resources to be available to test more women with less inconvenience for the patient.

Many antenatal testing units only have one VAS device, and these can cost up to $500. In addition, the Cochrane Review highlighted a need for further research into the realm of vibroacoustic stimulation in obstetric care, with particular attention to optimum intensity, frequency, duration, and position of the stimulation. Current devices, however, only come with one set frequency and intensity, making studies outlining optimal response rates with varying acoustic parameters impossible.

The investigators believe that the development of a mobile device (such as a phone) application which produces a vibroacoustic sound wave similar to that produced by the artificial larynx can address the aforementioned issues. This would make vibroacoustic stimulation more available, and allow for further testing with differing parameters such as frequencies, intensities, and duration of stimulation, which are easily adjusted with an application, but not an artificial larynx.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant patients at 32 to 42 weeks gestation who are already undergoing fetal heart rate monitoring in the hospital setting at Hutzel Hospital in Detroit, Michigan in triage, the antepartum floor, or on labor and delivery.

排除标准

  • Clinically unstable patients, patient who have been on magnesium sulfate or had opioid administration within the last 4 hours, fetuses with intrauterine growth restriction, patients contracting more than 3 times in 10 minutes, and twin pregnancies or higher order multiples.

结局指标

主要结局

Fetal heart rate accelerations

时间窗: within 15 minutes after vibroacoustic stimulation

The primary outcome will be the percentage of the time that one or more fetal heart rate accelerations occur within 15 minutes after vibroacoustic stimulation with a method.

次要结局

  • Fetal heart rate decelerations(within 15 minutes after vibroacoustic stimulation)

研究者

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

Michael Awadalla

Resident Physician

Wayne State University

研究点 (2)

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