PregnancyNCT07223996

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

A study testing PregnaOne System in people with Pregnancy and Fetal Monitoring, run by Nestmedic Spolka Akcyjna at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy, Fetal Monitoring
What is being tested?: PregnaOne System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 3 sitesUnited States
Study dates: 30 Sep 2025to 30 Jan 2026
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Christie Clinic, LLC
Champaign, Illinois, 61820
The Iowa Clinic, P.C.
West Des Moines, Iowa, 50266
Wilmington Health, PLLC
Wilmington, North Carolina, 28401

Other trials in United States

About this study

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.

Read the detailed description

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).

Conditions: Pregnancy, Fetal Monitoring
Being tested: PregnaOne System
Keywords: fetal heart rate monitoring, non-stress test, prenatal care, telemedicine, maternal health, home monitoring, PregnaOne System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PregnaOne SystemDevice
Also called Pregnabit Pro, PregnaOne Platform
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.

Study groups in NCT07223996
Study group	Role	What they receive
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. Receives: Device: PregnaOne System

What is being measured

The primary outcome is the main question the study is designed to answer.

Agreement Between PregnaOne System and Comparator Device (INVU System) for Fetal Heart Rate (fHR) Measurements
Agreement between fetal heart rate (fHR) measurements obtained with the PregnaOne System and the comparator device was assessed using Bland-Altman analysis. The reported values are the mean difference (PregnaOne minus INVU) and the lower and upper 95% limits of agreement, each presented with its corresponding 95% confidence interval.
Measured: At single study visit (Day 1)
Positive Percent Agreement Between PregnaOne System and Comparator Device (INVU System) for Uterine Activity Events
Positive percent agreement (PPA) for uterine activity events was calculated as the proportion of uterine activity events identified by the comparator device (INVU) that were also identified by the PregnaOne System, using the prespecified locked event-detection and matching algorithm. A two-sided bias-corrected and accelerated (BCa) 95% confidence interval was calculated.
Measured: 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. Successful self-monitoring was evaluated using two components: successful device placement as determined by an HCP and successful acquisition of a quality recording of fHR, uterine muscle activity, and mPR as determined by an HCP. Results for both components are reported separately.
Measured: At single study visit (Day 1)

Secondary outcomes (3)

Percent of Participants Who Obtain a Quality Maternal Pulse Rate (mPR) Recording
Percentage of participants whose PregnaOne recording session contained maternal pulse rate (mPR) values in at least 90% of recordings during simultaneous monitoring. This binary criterion was used to define a quality mPR recording for the final analysis.
Measured: At single study visit (Day 1)
Percent of Participants Who Successfully Place the Device
To determine the percentage of participants who successfully place the PregnaOne device as determined by a healthcare professional (HCP) during self-monitoring.
Measured: At single study visit (Day 1)
Percent of Participants Who Obtain a Quality Recording of fHR, Uterine Muscle Activity, and mPR During Self-Monitoring
To determine the percentage of participants who obtain a quality recording of fetal heart rate (fHR), uterine muscle activity, and maternal pulse rate (mPR) during self-monitoring, as assessed by a healthcare professional (HCP).
Measured: At single study visit (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202530 Jan 2026

First posted3 Nov 2025
Study start30 Sep 2025
Primary completion30 Jan 2026
Study completion30 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PregnancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07223996
Sponsor's protocol ID: 004
Status last verified: Oct 2026
First submitted: 24 Oct 2025
Last updated: 22 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
ClinicalTrials.gov ID: NCT07223996
Acronym / sponsor ID: 004
Conditions: Pregnancy, Fetal Monitoring
Keywords: fetal heart rate monitoring, non-stress test, prenatal care, telemedicine, maternal health, home monitoring, PregnaOne System
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Nestmedic Spolka AkcyjnaIndustry (pharma, biotech, devices)
Study start: 30 Sep 2025 (actual)
Primary completion: 30 Jan 2026 (actual)
Study completion: 30 Jan 2026 (actual)
First posted: 3 Nov 2025 (actual)
Results: Posted 22 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
PregnaOne System	Experimental	Device: PregnaOne SystemParticipants 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.

Who may qualify

Ages: 22 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PregnaOne SystemAlso: Pregnabit Pro, PregnaOne PlatformThe 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.	Device	PregnaOne System

Primary outcome

Agreement Between PregnaOne System and Comparator Device (INVU System) for Fetal Heart Rate (fHR) Measurements
Time frame: At single study visit (Day 1)
Agreement between fetal heart rate (fHR) measurements obtained with the PregnaOne System and the comparator device was assessed using Bland-Altman analysis. The reported values are the mean difference (PregnaOne minus INVU) and the lower and upper 95% limits of agreement, each presented with its corresponding 95% confidence interval.
Positive Percent Agreement Between PregnaOne System and Comparator Device (INVU System) for Uterine Activity Events
Time frame: At single study visit (Day 1)
Positive percent agreement (PPA) for uterine activity events was calculated as the proportion of uterine activity events identified by the comparator device (INVU) that were also identified by the PregnaOne System, using the prespecified locked event-detection and matching algorithm. A two-sided bias-corrected and accelerated (BCa) 95% confidence interval was calculated.
Percent of Participants Who Successfully Complete a Self-Monitoring Session
Time frame: At single study visit (Day 1)
To assess the ability of participants to successfully complete a self-monitoring session in a simulated home environment. Successful self-monitoring was evaluated using two components: successful device placement as determined by an HCP and successful acquisition of a quality recording of fHR, uterine muscle activity, and mPR as determined by an HCP. Results for both components are reported separately.

3 secondary outcomes

Percent of Participants Who Obtain a Quality Maternal Pulse Rate (mPR) Recording
Time frame: At single study visit (Day 1)
Percent of Participants Who Successfully Place the Device
Time frame: At single study visit (Day 1)
Percent of Participants Who Obtain a Quality Recording of fHR, Uterine Muscle Activity, and mPR During Self-Monitoring
Time frame: At single study visit (Day 1)

Results and safety

Results posted to the registry on 22 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PregnaOne Monitoring Group	71	71

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

Time frame: At single study visit (Day 1). Number (95% Confidence Interval). Unit: bpm

Measure	PregnaOne Monitoring Group n = 71
Mean difference (PregnaOne - INVU)	-0.31 (-0.77 to 0.16)
Lower limit of agreement	-4.19 (-4.98 to -3.40)
Upper limit of agreement	3.58 (2.79 to 4.37)

Population analysed: All 71 participants in the Intent-to-Evaluate Population contributed paired device data. The primary analysis included 73 analysis sessions.

Primary outcome: Positive Percent Agreement Between PregnaOne System and Comparator Device (INVU System) for Uterine Activity Events

Time frame: At single study visit (Day 1). Number (95% Confidence Interval). Unit: percentage of uterine activity events

Measure	PregnaOne Monitoring Group n = 61
Value	96.19 (92.99 to 97.88)

Population analysed: Ten participants were used for development and locking of the uterine activity event-detection algorithm and were excluded from the confirmatory validation analysis. The remaining 61 participants comprised the uterine activity event validation population before application of endpoint-specific evaluability criteria. Participants without an evaluable INVU event did not contribute to the PPA calculation.

Primary outcome: Percent of Participants Who Successfully Complete a Self-Monitoring Session

Time frame: At single study visit (Day 1). Number (95% Confidence Interval). Unit: percentage of participants

Measure	PregnaOne Monitoring Group n = 71
Successful device placement	98.59 (95.85 to 100.00)
Successful quality recording	90.14 (83.21 to 97.08)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study duration (up to 1 day per participant). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PregnaOne Monitoring Group	0 of 71 (0%)	0 of 71 (0%)	0 of 71

Limitations and caveats (from the sponsor): The fetal heart rate analysis included repeated measurements from some participants; therefore, not all analysis sessions were statistically independent. In addition, the study assessed device performance during a single study visit and did not evaluate long-term home use or repeated self-monitoring over time.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Official website of Nestmedic S.A., the sponsor of the study.Link provided by the sponsor.
Official website of the Pregnabit® system, a telemedical solution for remote fetal monitoring.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Szopa study director

Nestmedic Spolka Akcyjna

Jacek Gnich study chair

Nestmedic Spolka Akcyjna

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PregnaOne System in people with Pregnancy and Fetal Monitoring, run by Nestmedic Spolka Akcyjna at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement Between PregnaOne System and Comparator Device (INVU System) for Fetal Heart Rate (fHR) Measurements (time frame: At single study visit (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07223996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.