PregnaOne System for Fetal Monitoring

Recruiting at 2 trial locations

Overseen By Kendrick Adams

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nestmedic Spolka Akcyjna

Disqualifiers: Active labor, Severe hypertension, Implanted devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the PregnaOne System, a device for monitoring the baby's heart rate and the mother's contractions at home during the last trimester of pregnancy. It compares this new device with a similar, already-approved system to evaluate its performance. Pregnant women between 32 and 41 weeks along who can attend a study visit may be suitable candidates for this trial.

As an unphased trial, this study allows participants to contribute to advancing home monitoring technology for expectant mothers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the PregnaOne System is safe for in-home fetal monitoring?

Previous studies have found that the PregnaOne System has a low-risk profile, indicating it is generally safe to use. Designed for home use, this system monitors the baby's heart rate and other vital signs during pregnancy. The low-risk classification means no major safety issues have been reported. This classification is based on the device's design and usage, aiming to ensure the safety of both mother and baby. For any safety concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PregnaOne System is unique because it allows for non-stress fetal monitoring in a home-like setting, which is a shift from traditional in-clinic monitoring methods. Unlike standard fetal monitoring, which usually requires visits to a healthcare facility and the use of complex machinery, PregnaOne is designed for easy self-monitoring at home. Researchers are excited about this system because it promises to make fetal monitoring more accessible and convenient for expectant mothers, potentially improving compliance and early detection of fetal issues. It also aims to match or exceed the performance of existing systems, like the INVU system, in a more user-friendly manner.

What evidence suggests that the PregnaOne System is effective for fetal monitoring?

Research has shown that monitoring a baby's health from home can greatly benefit both mothers and their babies. The PregnaOne System, used by participants in this trial, is designed for home use and promises accuracy and effectiveness. Studies indicate that systems like these can correctly detect a baby's movements about 85% of the time. This accuracy allows pregnant women to monitor their baby's health without needing to visit a hospital. Overall, remote monitoring with systems like the PregnaOne System makes it easier and safer to check on a baby's health from home. ^{1 6 7 8 9}

Who Is on the Research Team?

Anna Szopa

Principal Investigator

Nestmedic Spolka Akcyjna

Jacek Gnich

Principal Investigator

Nestmedic Spolka Akcyjna

Are You a Good Fit for This Trial?

This trial is for pregnant women in their third trimester who are interested in testing a new fetal monitoring device at home. Participants should be willing to undergo training and two monitoring sessions during one study visit.

Inclusion Criteria

I am a woman aged 22 or older.

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

Estimated gestational age between 32 and 41 weeks

Exclusion Criteria

I have skin issues where the device will be placed.

In active labor or in the delivery room during labor

Any contraindications for cardiotocography (CTG) monitoring

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training

Participants are instructed on how to use the PregnaOne System

Single session

1 visit (in-person)

Monitoring

Participants undergo two monitoring sessions: simultaneous use of the PregnaOne System and the INVU system, followed by self-monitoring using only the PregnaOne System

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the monitoring sessions

1 day

What Are the Treatments Tested in This Trial?

Interventions

• PregnaOne System

Trial Overview The PregnaOne System, which includes the Pregnabit Pro device and software for recording fetal heart rate, maternal pulse, and uterine contractions at home, is being tested against an FDA-cleared system called INVU.

How Is the Trial Designed?

Group I: PregnaOne System Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Nestmedic Spolka Akcyjna

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9996419/

Effectiveness of Remote Fetal Monitoring on Maternal-Fetal ... This systematic review has demonstrated that remote fetal monitoring has a significant effect on improving maternal and infant outcomes, but this does not mean ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07223996

Use of In-Home Non-Stress Monitoring Device for Fetal ... This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0301211524006924

Continuous remote home monitoring solutions for mother ... The system showed 85 % accuracy in detecting fetal movement, demonstrating effectiveness for long-term home monitoring.

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.18097

Advancements in Fetal Heart Rate Monitoring: A Report on ... Cardiotocography (CTG), introduced in the 1960s, was initially expected to prevent hypoxia-related deaths and neurological injuries.

5. ajog.org ajog.org/article/S0002-9378(22)02163-9/fulltext

Improving the interpretation of electronic fetal monitoring With the routine use of electronic fetal monitoring, the cesarean delivery rate increased from <5% in the 1970s to >30% at present. Most at-risk ...

6. pregna.one pregna.one/pregnaone-ifu-patient-en/

PregnaOne Platform Instructions for use for Patient Summary of the medical device risk profile and associated IT security objectives: ▫. This medical device processes sensitive data, including medical data and ...

7. medicaldevicenavigator.com medicaldevicenavigator.com/fetal_monitoring_pregnaone_system_study/

Exploring the NSR PregnaOne System Study The PregnaOne System is described as a device specifically tailored for in-home fetal monitoring during pregnancy. While full technical ...

8. clinconnect.io clinconnect.io/trials/NCT07223996?queryID=057ffad710f758d82a5b&apos=3

Use of In-Home Non-Stress Monitoring Device for Fetal This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8157941/

Comprehensive pregnancy monitoring with a network of ... The system we present here provides objective and real-time data outputs on the impact of maternal body position on both maternal and fetal ...