Comparison of SureCALL® EMG Labor Monitor® and Tocodynamometer to Intrauterine Pressure Catheter Measurement in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC
研究概览
简要总结
This measurement study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®) to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
详细描述
The SureCALL® EMG Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
This measurement study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".
This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:
- a tocodynamometer attached to the maternal abdomen
- a set of abdominal surface electrodes for uterine electromyography, and
- an intrauterine pressure catheter.
Using IUPC as the "gold standard", this study methodology allowed a three way comparison for evaluating how well the SureCALL® system performed compared to the TOCO technology.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Singleton Pregnancy
- •Indicated for IUPC
- •Gestational ages from 37 to 41 weeks
- •Informed consent required
排除标准
- •Multifetal Pregnancy
- •Not Indicated for IUPC
- •Gestation ages below 37 or above 41 weeks
- •Informed consent not given
结局指标
主要结局
Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC
时间窗: 9 - 42 Minutes
Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.
次要结局
未报告次要终点