Study to Determine Substantial Equivalence of Electrohysterography (EHG) Monitoring to Tocodynanometer Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
研究概览
简要总结
Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.
详细描述
The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant, age 15-40
- •Term gestation (>36 completed weeks)
- •Singleton fetus
- •Active labor
- •Vertex presentation
- •Requiring internal monitoring
排除标准
- •Clinical contraindication for Intra Uterine Pressure Catheter
- •Major fetal malformation
结局指标
主要结局
The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
时间窗: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
During Labor \& delivery, fetal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.
The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM
时间窗: during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour
During Labor \& delivery, maternal heart rate was measured between the Monica AN24 \& the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.
次要结局
- The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM(between 35 mins & 15hrs during first & second stage labor)