跳至主要内容
临床试验/NCT01400880
NCT01400880已完成早期 1 期

Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability

Convergent Engineering, Inc.1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
103
试验地点
1
主要终点
Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC

研究概览

简要总结

The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer and Doppler ultrasound.

详细描述

The majority of obstetric deliveries in the US undergo electronic monitoring and continuous uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically, external transducers are employed, the reliability of which depends on their proper positioning, which may be disturbed by patient or fetal movement. The tocodynamometer (strain gauge, toco for short) provides frequency and timing of contractions, but requires transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an external Doppler ultrasound transducer. The reliability of this monitor depends on the ability to obtain a window to the fetal heart.

In some patients, particularly the obese, the toco and ultrasound may fail to monitor consistently. In others both transducers require frequent repositioning by the nursing staff, and the Doppler may erroneously report maternal heart rate instead of fetal.

The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which is placed through the cervical os in the adequately dilated patient with ruptured membranes. While this monitor usually provides a more reliable signal than the toco, as well as quantitative information regarding intrauterine pressure, it is invasive and there is an increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE), which is applied transvaginally to the fetal presenting part, also requiring adequate cervical dilation and ruptured membranes. While the FSE usually provides a more reliable signal, it is similarly invasive and increases risk of infection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

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

  • Women between the ages of 18 and 50 years old
  • >/= 34 weeks gestation
  • Single viable fetus in cephalic presentation

排除标准

  • Bleeding or uterine scarring

研究组 & 干预措施

Pregnant

Experimental

In Labor

干预措施: Electrode-based Sensor (Device)

结局指标

主要结局

Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC

时间窗: Stage I and II Labor

Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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