Noninvasive Monitoring of Uterine Electrical Activity and Fetal Heart Rate: A New External Monitoring Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Continuity in Readings of Contractions
研究概览
简要总结
The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring obese patients with current method of external tocodynamometry with the EUM device. Providers will be blinded to the results of the EUM device. Caregivers will continue care as per current guidelines using the information obtained from the current monitoring methods. Information obtained from the EUM devices will not be used to determine the clinical course of action.
详细描述
Purpose:
The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by comparing it with simultaneous use of current methods (external tocodynamometry) among obese patients.
Objective
Compare the interpretability of the contractions recorded using the EUM device vs. those obtained from external tocodynamometer among obese pregnant women.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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
- 是
入选标准
- •Maternal age >18 years old
- •Singleton pregnancy
- •Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound
- •Category I (reassuring) fetal heart rate tracing at time of enrollment
排除标准
- •Fetal anomaly or chromosome defect
- •Allergy to silver
- •Woman with implanted electronic device of any kind
- •Irritated skin or open wound on the abdominal wall
结局指标
主要结局
Continuity in Readings of Contractions
时间窗: within 4 hours of device application
Continuity in readings of contractions, as measured in the number of minutes without a readable tracing in a sample tracing, between the novel EUM device and the external tocodynamometer (standard care) were assessed in pregnant preterm patients. An uninterpretable tracing was defined as any contraction, or any period of contractions, with unclear/uninterpretable baseline, peak onset/timing, height/peak, or duration of contraction.
Continuity in Readings of Fetal Heart Rate
时间窗: within 4 hours of device application
Continuity in Fetal Heart rate readings, as measured by the number of minutes without a readable tracing in a sample tracing between the novel EUM/EMG device and the external tocodynamometer (standard care) will be assessed in pregnant preterm patients. An uninterpretable tracing is defined as any period of fetal heart rate tracing with unclear/uninterpretable baseline, variability, onset/timing, peak, frequency, or duration of accelerations/decelerations
次要结局
未报告次要终点