The Monica External Fetal Heart Rate Monitor Compared to the Standard Fetal Heart Rate Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device
研究概览
简要总结
The goal of this study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.
详细描述
If a patient is admitted to the antepartum service and is between 24 - 28 weeks gestation, the investigators will approach the patient and inform her about the study. If the patient agrees to the study then the baby's heart tracings and contraction pattern will start to be monitored using the traditional device. If the patient would be receiving continuous fetal heart rate monitoring, then after at least 2 hours of monitoring with the traditional device, the traditional device would be replaced with the Monica device for 2 hours. After the Monica device is used for 2 hours, then the traditional device would be used once again. The entire length of the patient's participation in the study should be nor more than 6 hours.
The data collection sheet shows all data elements to be collected from the medical record. In addition it is standard of care that the monitoring strips become part of the medical records and these will also be reviewed as per the data collection sheet. Time it should take to review a patients medical record will be about 1 hour.
Total time of patient's involvement will be 7 hours.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients between 24 and 28 weeks admitted to the antepartum service
排除标准
- •Patients with a non viable pregnancy
- •Patients with multiple gestation
- •Clinically Unstable patients
- •Non English speaking patients
结局指标
主要结局
To compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device
时间窗: How long can hetal heart tracings be capture continuously
This study is to compare the amount of time that the fetal heart tones are traced in babies just at or beyond viability using a traditional device compared to the Monica device.
次要结局
未报告次要终点
研究者
fruhman@slu.edu
PI
St. Louis University