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
- 发起方
- Yariv yogev
- 入组人数
- 100
- 试验地点
- 1
- 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
Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.
详细描述
Once in labor, the parturient will be connected to the routine fetal doppler and EUM. When necessary according to clinical indications, the scalp electrode will be connected. Tracing will be recorded simultaneously from all three devices until delivery.
study design:
- signing an informed consent at vas<3
- admittance to delivery room.
- Verifying inclusion and exclusion criteria, describing clinical rial goal, motivation and phases.
- Connecting the patient to three devices (fetal Doppler, scalp electrode and EUM) simultaneously.
- Recording fetal heart rate until delivery.
- Disconnecting the patient from all devices if required according to clinical need.
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 45 Years（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 (Biophysical Profile) 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 singed and dated the written informed consent form before initiation of protocol specified procedures, when vas<3.
排除标准
- •Women who refuse to sign the informed consent form.
- •Maternal age<18 years.
- •Multiple pregnancy.
- •Women with implanted electronic device of any kind.
- •Women 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: 12 month
Mean Positive Percent Agreement (PPA) for interpretable/un interpretable traces (between EUM, scalp electrode and fetal doppler).
次要结局
- Adverse events(12 months)
- Reliability(12 months)
- Accuracy(12 months)
研究者
Yariv yogev
Prof. Yariv Yogev Director, Division of Obstetrics and Delivery Ward
Rabin Medical Center