Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing
研究概览
简要总结
This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.
详细描述
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, 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® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:
- Standard tocodynamometer attached to the maternal abdomen,
- SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen
Subjects did not recieve any interventions as a part of this study.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton Pregnancy
- •Informed Consent Required
排除标准
- •Multifetal Pregnancy
- •Informed Consent Not Given
结局指标
主要结局
Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing
时间窗: 9 - 41 Minutes
Time Stamps of the Peaks of Corresponding Contractions
次要结局
未报告次要终点