Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 3
- 主要终点
- Agreement Between PregnaOne System and Comparator Device (INVU System) for Fetal Heart Rate (fHR) Measurements
研究概览
简要总结
This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal monitoring in pregnant women during the third trimester. The PregnaOne System consists of the Pregnabit Pro device and related software, designed to record fetal heart rate, maternal pulse, and uterine contractions in a home-like environment. The study compares the performance of the PregnaOne System with a similar FDA-cleared at-home monitoring system (the INVU system by Nuvo). Approximately 70 pregnant women will participate at three medical centers in the United States. Each participant will complete one training session and two fetal monitoring sessions during a single study visit.
详细描述
This is a prospective, single-visit, non-randomized, comparative study designed to evaluate the PregnaOne System, an investigational Class II medical device intended for in-home fetal monitoring. The system includes the Pregnabit Pro device and associated software that collect and transmit data on fetal heart rate, fetal movement, maternal pulse rate, and uterine muscle activity for remote review by healthcare professionals.
The goal of this study is to assess the safety, usability, and signal performance of the PregnaOne System compared to the INVU system, an FDA-cleared home fetal monitoring device. The study will be conducted under a non-significant risk (NSR) designation.
Approximately 70 pregnant women in their third trimester will be enrolled at three U.S. medical centers. Each participant will attend one in-clinic visit simulating an at-home environment. The study visit includes:
Training session - participants are instructed on how to use the PregnaOne System.
First monitoring session - a 30-minute fetal monitoring period using both the PregnaOne System and the INVU system simultaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Open-label study. Participants and study personnel are aware of the device being used.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to independently read and understand written and spoken English and willing to provide written informed consent and comply with all instructions required by the study protocol.
- •Female aged 22 years or older.
- •Estimated gestational age between 32 and 41 weeks.
- •Singleton gestation.
- •Pre-pregnancy or first prenatal visit BMI < 40 kg/m².
- •Able and willing to undergo fetal monitoring sessions in a simulated home environment at the study site.
- •Women who do not meet the gestational age criterion at the screening visit but will meet it by the study visit (within two weeks) may be enrolled.
排除标准
- •In active labor or in the delivery room during labor.
- •Requires hospitalization or life support.
- •Any contraindications for cardiotocography (CTG) monitoring.
- •Severe hypertension (≥160/110 mmHg measured twice, 15 minutes apart).
- •Known allergy to latex, ultrasound (US) gel, or ECG gel.
- •Skin conditions (e.g., edema, erythema, irritation, infection, lesions, or open wounds) at contact points for the Pregnabit Pro or comparator devices.
- •Implanted electronic devices (e.g., pacemaker, stimulator, defibrillator, pump).
- •Members of vulnerable populations other than pregnant women (e.g., minors, wards of the state, cognitively impaired individuals, prisoners, or institutionalized persons).
研究组 & 干预措施
PregnaOne System
Participants will use the PregnaOne System for fetal monitoring during a single study visit. Each participant will complete two monitoring sessions:
- Simultaneous use of the PregnaOne System and the INVU system.
- Self-monitoring using only the PregnaOne System. The study aims to evaluate the usability, safety, and performance of the PregnaOne System for non-stress fetal monitoring in a home-like setting.
干预措施: PregnaOne System (Device)
结局指标
主要结局
Agreement Between PregnaOne System and Comparator Device (INVU System) for Fetal Heart Rate (fHR) Measurements
时间窗: At single study visit (Day 1)
To assess the agreement between fetal heart rate (fHR) measurements obtained with the PregnaOne System and those obtained with the comparator device during simultaneous monitoring. Agreement will be evaluated using correlation and Bland-Altman analysis.
Percent of Participants Who Obtain a Quality Maternal Pulse Rate (mPR) Recording
时间窗: At single study visit (Day 1)
To determine the proportion of participants who obtain a quality maternal pulse rate (mPR) recording during simultaneous monitoring, defined as a valid and stable signal without major artifacts.
Agreement Between PregnaOne System and Comparator Device (INVU System) for Uterine Muscle Activity Measurements
时间窗: At single study visit (Day 1)
To assess the agreement between uterine muscle activity measurements obtained with the PregnaOne System and those obtained with the comparator device during simultaneous monitoring. Agreement will be evaluated using correlation and Bland-Altman analysis.
Percent of Participants Who Successfully Complete a Self-Monitoring Session
时间窗: At single study visit (Day 1)
To assess the ability of participants to successfully complete a self-monitoring session in a simulated home environment, including correct device placement and successful recording of signals, as determined by a healthcare professional (HCP).
Agreement Between PregnaOne System and Comparator for Fetal Heart Rate (fHR)
时间窗: At single study visit (Day 1)
To evaluate the agreement between fetal heart rate (fHR) measurements obtained using the PregnaOne System and those obtained using the comparator device. fHR data will be analyzed to determine correlation, limits of agreement, and measurement bias between the two systems.
Agreement Between PregnaOne System and Comparator for Uterine Muscle Activity
时间窗: At single study visit (Day 1)
To evaluate the agreement between uterine muscle activity measurements obtained using the PregnaOne System and those obtained using the comparator device. Data will be analyzed to determine correlation, limits of agreement, and measurement bias.
次要结局
- Percent of Participants Who Obtain a Quality Maternal Pulse Rate (mPR) Recording(At single study visit (Day 1))
- Percent of Participants Who Successfully Place the Device(At single study visit (Day 1))
- Percent of Participants Who Obtain a Quality Recording of fHR, Uterine Muscle Activity, and mPR During Self-Monitoring(At single study visit (Day 1))