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临床试验/NCT02691884
NCT02691884Unknown不适用

The Effect of Pressure Exerted on the Maternal Abdominal Wall by the Ultrasound Probe on Fetal Heart Rate

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Changes in fetal baseline heart rate, including accelerations and decelerations

研究概览

简要总结

The aim of the study is to assess the change of fetal heart rate in response to the amount of pressure exerted on the maternal abdomen. The amount of pressure will be quantified using an electronic pressure sensor (FSR 400- Round Force Sensor, Interlink).

详细描述

Previous studies have shown a fetal cardiovascular effect to the pressure exerted on the maternal abdomen. Our null hypothesis is that there is a correlation between fetal heart rate changes and pressure exerted on the fetus through the maternal abdomen.

Women at term pregnancy coming for a routine cardiotocography monitor, will undergo 5 minutes of quantified pressure on their abdomen, using the electronic pressure sensor. The amount of pressure will be recorded as well as the fetal heartbeat baseline and changes to the heart rate following the application of pressure.

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

入选标准

  • over 18 years of age
  • singleton pregnancy
  • term (37-41 weeks of gestation)
  • consented
  • undergoing routine cardiotocography (CTG)

排除标准

  • referred to the ER due to non reassuring fetal heart rate (NRFHR)
  • recognition of NRFHR pattern on CTG at the ER
  • self reporting of reduced fetal movement perception
  • unconsented patient

结局指标

主要结局

Changes in fetal baseline heart rate, including accelerations and decelerations

时间窗: immediately after applying pressure to the maternal abdomen

pressure will be applied after the 20th minute of CTG monitoring and for a total of 5 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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