A Prospective, Blinded Clinical Study to Compare the Efficacy Between Three Fetal Monitoring Methods: Electro Uterine Monitor (EUM), Fetal Doppler and Scalp Electrode
试验速览
- 阶段
- 3 期
- 入组人数
- 400
- 主要终点
- The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
研究概览
简要总结
Background:
Identification and measurement of fetal heart tracings throughout pregnancy and labor is crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most common indications for operative vaginal delivery or cesarean section. Therefore, management of labor requires reliable and accurate information about fetal heart rate.
In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic changes (accelerations or decelerations). In each stage of labor the tracing may have different characteristics, with variable decelerations much more common at the end of the second stage of labor.
Objective:
To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the same patients.
详细描述
Background:
Identification and measurement of fetal heart tracings throughout pregnancy and labor is crucial to the well-being of the fetus. Non reassuring fetal heart rate is one of the most common indications for operative vaginal delivery or cesarean section. Therefore, management of labor requires reliable and accurate information about fetal heart rate.
In most normal spontaneous labors, fetal heart rate is characterized by the baseline heart rate (from 110 to 160 beats per minute), variability (beat to beat changes) and periodic changes (accelerations or decelerations). In each stage of labor the tracing may have different characteristics, with variable decelerations much more common at the end of the second stage of labor.
Objective:
To Show non inferiority of the EUM to the fetal doppler and scalp electrode by comparing the reliability and accuracy of the EUM versus fetal doppler compared to scalp electrode in the same patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •Clinical indication to insert a scalp electrode for fetal heart rate tracing.
- •Maternal age >18 years
- •Reactive fetal heart rate monitoring and BPP 8/8 at enrollment
- •Singleton pregnancy
- •No fetal abnormality or chromosomal defect
- •Subjects are willing and able to comply with the requirements of the protocol.
- •Fully understand all elements of, and have signed and dated, the written informed consent form before initiation of protocol-specified procedures, when VAS <3.
排除标准
- •Women who refused to sign the informed consent form.
- •Maternal age < 18 years.
- •Multiple pregnancy
- •Woman with implanted electronic device of any kind
- •Woman with allergic to silver.
- •Irritated skin or open wound
结局指标
主要结局
The difference between the fetal scalp electrode tracings and the EUM tracings of the fetal heart activity.
时间窗: Up to 72 hours
Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).
Reliability
时间窗: Up to 72 hours
Mean sensitivity for individual tracing identification (between EUM, scalp electrode and fetal doppler)
次要结局
未报告次要终点