NCT05782296已完成不适用
Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate: TrueLabor™, A New External Monitoring Device: Prospective Observational Study
OB-Tools Ltd.3 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2022年2月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity
研究概览
简要总结
A clinical study designed to validate the safety and performance of the TrueLabor™ device in monitoring labor vs. current standard of care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are on >=37w0d of gestation
- •Maternal age > 18 years old
- •Singleton pregnancy
- •Cephalic presentation
- •Patient requiring internal monitoring for obstetric indications
- •Informed consent
排除标准
- •Major fetal anomalies
- •Patients with implanted electronic devices of any kind
- •Patients using exterior electronic devices of any kind during the procedure
- •Patients with irritated skin or open wound on the abdominal wall
结局指标
主要结局
Safety, comparative performance, and reliability of the TrueLabor™ system for Uterine Activity
时间窗: Through labor, until delivery
This will be performed using a Performance Goal
Safety, comparative performance, and reliability of the TrueLabor™ system for Fetal Heart Rate
时间窗: Through labor, until delivery
This will be performed using a Performance Goal
次要结局
- Effect of BMI (weight in Kg, height in meters will be combined to report BMI in kg/m2)(Through labor, until delivery)
研究者
研究点 (3)
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