Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study

Nestmedic Spolka Akcyjna70 enrolled

Overview

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.

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. Second monitoring session - a 30-minute self-conducted monitoring session using only the PregnaOne System without staff assistance. During each session, participants remain in a seated or reclined position and record fetal movements. Study staff will be available to assist and ensure participant safety. No known risks are associated with fetal heart rate monitoring, though mild discomfort from device straps may occur. Participants receive compensation for their time and travel. Study data will support the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA).

Study Type

INTERVENTIONAL

Allocation

Interventions

PregnaOne SystemDEVICE

The PregnaOne System is a non-significant risk (NSR) investigational medical device designed for in-home fetal monitoring. It includes the Pregnabit Pro device and the cloud-based PregnaOne Platform software. The system records fetal heart rate, maternal pulse, and uterine activity, transmitting data to a remote monitoring center for clinical evaluation. During the study, participants will perform two monitoring sessions: 1. Simultaneous use of the PregnaOne and INVU systems. 2. Independent monitoring using only the PregnaOne System. The study evaluates the usability, safety, and performance of the PregnaOne System in comparison with a reference device.

Eligibility

Sex: FEMALEMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Outcomes

Primary Outcomes

Agreement Between PregnaOne System and Comparator Device (INVU System) for Fetal Heart Rate (fHR) Measurements

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.