Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
NCT ID: NCT07223996
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-10-01
2026-06-30
Brief Summary
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Detailed Description
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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 50 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).
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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PregnaOne System
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.
PregnaOne System
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.
Interventions
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PregnaOne System
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
22 Years
FEMALE
Yes
Sponsors
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Nestmedic Spolka Akcyjna
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Szopa
Role: STUDY_DIRECTOR
Nestmedic Spolka Akcyjna
Jacek Gnich
Role: STUDY_CHAIR
Nestmedic Spolka Akcyjna
Locations
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Christie Clinic, LLC
Champaign, Illinois, United States
The Iowa Clinic, P.C.
West Des Moines, Iowa, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Official website of Nestmedic S.A., the sponsor of the study.
Official website of the Pregnabit® system, a telemedical solution for remote fetal monitoring.
Other Identifiers
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004
Identifier Type: -
Identifier Source: org_study_id
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