Clinical Study Evaluating the Safety of Invu ™ and Comparative Performance of Invu ™ Versus IUPC in Prenatal Monitoring of Pregnant Subjects With Uterine Contractions.
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
- 4
- 主要终点
- Assessment of the agreement between INVU™ and IUPC (the gold standard) during monitoring of uterine contractions as well as the agreement between Cardiotocography (TOCO) and IUPC, where applicable.
研究概览
简要总结
The primary objective of this research is to assess the agreement between INVU™ and IUPC (the gold standard) during prenatal monitoring of uterine contractions and to assess the safety of INVU™. Additional information comparing INVU™ to TOCO (the standard of care) was also collected.
详细描述
This multi-center, prospective, comparative, open-label study will be performed in two steps: A training step where up to 40 subjects will be enrolled to confirm uterine contraction performance level.
In the second, validation step, the performance of the uterine contraction detection algorithm will be validated. The validation phase will involve up to 80 subjects.
Sub-study will be implemented in the sites that will monitor the uterine activity of the subjects with TOCO, in addition to INVU™ and IUPC.
Following the screening process, participants subject will undergo continuous recording of the uterine contraction and the fetal heart rate (FHR) for 30 to 60 min using INVU™, Cardiotocograph ((TOCO / CTG), and Intrauterine Pressure Catheters (IUPC). The collected data will be downloaded and comprehensive analysis of the values will be performed offline. Each participant will undergo continuous monitoring by the medical team to identify any safety issue, including but not limited to irritation, sensitization, and potential harmful misuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female age between 18-50
- •Gestational age ≥32 + 0 weeks
- •Singleton gestation
- •Ability to understand and sign informed consent
- •The subject is within the first stage labor, including early, active and transition phases (cervix is dilated up to 10 cm)
- •The subject has an IUPC in place for clinical contraction monitoring
排除标准
- •BMI ≥50 and 15≤ prior pregnancy (Body Mass Index)
- •Multiple gestation
- •Uncontrolled Hypertension
- •Known fetal Anomaly (i.e. major structural)
- •Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
- •Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
- •Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study
- •Subject who is within the second stage labor (cervix is fully dilated to 10 cm or going into the second stage of labor or more)
结局指标
主要结局
Assessment of the agreement between INVU™ and IUPC (the gold standard) during monitoring of uterine contractions as well as the agreement between Cardiotocography (TOCO) and IUPC, where applicable.
时间窗: 30-60 minutes per participant
Three blinded assessors will review the uterine contractions output data (the recordings) from the monitoring devices and determine for each time point whether a contraction occurred. The assessors will not have visibility to the source of the recorded data. Each assessor will review the sessions in a randomized order, while the evaluation will include: a contraction start point, peak, and endpoint. The actual presence of a contraction will be determined by the IUPC.
次要结局
未报告次要终点