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

NCT07223996 | Completed FDA Device

• 1 other identifier: 004
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pregnancy; Fetal Monitoring

Keywords

fetal heart rate monitoring; non-stress test; prenatal care; telemedicine; maternal health; home monitoring; PregnaOne System

Outcome Measures

Primary Outcomes (6)

• 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.

  At single study visit (Day 1)

• Agreement Between PregnaOne System and Comparator Device (INVU System) for Uterine Muscle Activity Measurements

  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.

  At single study visit (Day 1)

• Percent of Participants Who Obtain a Quality Maternal Pulse Rate (mPR) Recording

  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.

  At single study visit (Day 1)

• Percent of Participants Who Successfully Complete a Self-Monitoring Session

  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).

  At single study visit (Day 1)

• Agreement Between PregnaOne System and Comparator for Fetal Heart Rate (fHR)

  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.

  At single study visit (Day 1)

• Agreement Between PregnaOne System and Comparator for Uterine Muscle Activity

  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.

  At single study visit (Day 1)

Secondary Outcomes (3)

• 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)

Other Outcomes (1)

• Frequency, Type, and Severity of Adverse Events (AEs) and Adverse Device Effects (ADEs)

  Throughout the study duration (up to 1 day per participant)

Study Arms (1)

PregnaOne System

EXPERIMENTAL

Participants will use the PregnaOne System for fetal monitoring during a single study visit. Each participant will complete two monitoring sessions: 1. Simultaneous use of the PregnaOne System and the INVU system. 2. 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.

Device: PregnaOne System

Interventions

PregnaOne System DEVICE

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.

Also known as: Pregnabit Pro, PregnaOne Platform

PregnaOne System

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nestmedic Spolka Akcyjna: lead

Study Sites (3)

Christie Clinic, LLC

Champaign, Illinois, 61820, United States

Location

The Iowa Clinic, P.C.

West Des Moines, Iowa, 50266, United States

Location

Wilmington Health, PLLC

Wilmington, North Carolina, 28401, United States

Location

Related Links

• Official website of Nestmedic S.A., the sponsor of the study.
• Official website of the Pregnabit® system, a telemedical solution for remote fetal monitoring.

Study Officials

• Anna Szopa

  Nestmedic Spolka Akcyjna

  STUDY DIRECTOR

• Jacek Gnich

  Nestmedic Spolka Akcyjna

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label study. Participants and study personnel are aware of the device being used.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will complete one study visit including two monitoring sessions: (1) simultaneous use of the PregnaOne System and INVU system, and (2) self-monitoring using only the PregnaOne System. No randomization or parallel assignment is applied.

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: November 3, 2025
• Study Start: September 30, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)