Fetal Monitoring Device for Pregnancy

Overseen By Amie L Research Program Integrator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: GE Healthcare

Disqualifiers: Multiple pregnancy, Other trial, Medical problem, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new fetal monitoring device that helps doctors track the health of both the mother and baby during pregnancy. The goal is to determine if this new device performs as well as an existing one on the market. Researchers will divide participants into groups based on their stage of pregnancy, and each will undergo two 30-minute monitoring sessions. Pregnant women carrying one baby and who are at least 22 weeks along may be suitable for this study. As an unphased trial, participants can contribute to advancing medical technology and improving prenatal care.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this fetal monitoring device is safe for pregnancy?

Earlier research has found devices like the one under testing to be comfortable for patients. For instance, one study examined a similar device called the PregnaOne System, which was considered low-risk, meaning it did not cause major safety problems during testing. Another study assessed the safety and effectiveness of the Marani Fetal Monitoring Telehealth System, which aimed to ensure the device was safe for tracking fetal heart rates.

These studies suggest that the fetal monitoring device under testing is likely safe to use. However, as with any medical device, monitoring participants' reactions during the trial is crucial to ensure no unexpected problems arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tests a new fetal monitoring device that could offer enhanced accuracy and reliability over existing options. Current standard devices often rely on older technologies that may not always provide consistent readings. This investigational device is being compared directly with an FDA-approved device to see if it can deliver more precise monitoring of both the fetal heart rate and maternal pulse rate. By potentially offering clearer and more reliable data, this new device could improve prenatal care and outcomes for both mothers and their babies.

What evidence suggests that this fetal monitoring device is effective for pregnancy?

This trial will evaluate a new investigational fetal monitoring device, which can be used at home and sends data quickly and accurately through regular phone lines. Participants will be divided into groups based on gestational age and will undergo monitoring sessions with both an FDA-approved device and the investigational device. Studies have shown that fetal monitoring devices effectively track a baby's health before birth. Remote fetal monitoring can reduce the risk of problems like neonatal asphyxia, when a baby doesn't get enough oxygen at birth, and can also be more cost-effective than traditional methods. Research indicates that this investigational device is about 85% accurate in detecting fetal movements, which is promising for long-term monitoring. This suggests it could be as effective as other similar devices already in use. ^{1 2 6 7 8}

Who Is on the Research Team?

Monica Rabanal, NP, Medical Director

Principal Investigator

Element Materials Technology

Are You a Good Fit for This Trial?

This clinical trial is for pregnant women who are carrying one baby (singleton pregnancy). It's designed to test a new fetal monitoring device during pregnancy and delivery. Participants should be in good health with no conditions that would interfere with the study.

Inclusion Criteria

Able and willing to provide written informed consent

Singleton pregnancy

Greater than or equal to 22 0/7 weeks gestation

Exclusion Criteria

I have a health condition that may prevent me from participating in the study.

Multiple pregnancy

Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Participants undergo two 30-minute monitoring sessions using both the investigational and FDA-approved devices to collect fetal heart rate and movement data.

60 minutes

1 visit (in-person)

Safety Analysis

Analysis of adverse events and collection of safety data over the course of the study.

4 months

Follow-up

Participants are monitored for safety and effectiveness after the monitoring sessions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational Fetal Monitoring Device

Trial Overview The trial is testing a new fetal monitoring device against an existing one, Corometrics 259cx. The goal is to see if the new device can match or improve on the performance of the current standard by tracking fetal heart rate using Doppler ultrasound.

How Is the Trial Designed?

Group I: Group 1: 22 0/7 - 24 6/7 Weeks Active Control 2 Interventions

All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed

Group II: Group 2: 25 0/7 - 31 6/7 Weeks Active Control 2 Interventions

All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.

Group III: Group 3: Greater than or equal to 32 0/7 Weeks Active Control 2 Interventions

All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.

Investigational Fetal Monitoring Device is already approved in United States for the following indications:

Approved in United States as Investigational Fetal Monitoring Device for:

• Monitoring fetal and maternal physiologic data during pregnancy and delivery

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Published Research Related to This Trial

The study developed a hybrid model using 1D-CNN and GRU to analyze fetal heart rate and uterine contraction signals, achieving a high accuracy of 95.15% in classifying fetal health status.

This model demonstrated excellent sensitivity (96.20%) and specificity (94.09%), indicating its potential to effectively assist obstetricians in making clinical decisions regarding fetal health during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A CNN-RNN unified framework for intrapartum cardiotocograph classification. Liang, H., Lu, Y.[2023]

Continuous fetal monitoring (CFM) has the potential to provide a more comprehensive assessment of fetal wellbeing compared to traditional intermittent methods, which only offer brief 'snapshots' of fetal status.

The review identified 24 different CFM devices using various technologies, but highlighted a lack of standardized performance assessment, making it difficult to compare their effectiveness and identify the best options for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic scoping review to identify the design and assess the performance of devices for antenatal continuous fetal monitoring. Tamber, KK., Hayes, DJL., Carey, SJ., et al.[2023]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

The paper emphasizes the importance of continuously evaluating safety data for medical products after they are approved, highlighting that safety profiles evolve as more data is collected.

It discusses the use of advanced statistical and graphical methods for analyzing large postmarketing surveillance databases, which have grown significantly due to improved reporting practices, to effectively detect safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance. Izem, R., Sanchez-Kam, M., Ma, H., et al.[2020]

A new framework for monitoring adverse events (AEs) in pregnancy trials has been developed, which includes specific definitions and severity grading for both maternal and fetal AEs, enhancing safety assessments for drugs and interventions.

The framework was created through a comprehensive literature review and consensus from an international group of experts, resulting in 12 maternal and 19 fetal AE definitions that can be systematically applied in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Spencer, RN., Hecher, K., Norman, G., et al.[2022]

During labor, fetal pulse oximetry showed a significant decrease in average and maximum oxygen saturation (SpO2) from the first to the second stage, indicating potential stress on the fetus.

Higher fetal SpO2 levels during the first stage of labor were correlated with better neonatal outcomes, such as umbilical vein pH and pO2, suggesting that monitoring SpO2 can help predict newborn health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The usefulness of the intrapartum fetal pulse oximetry in anticipating the neonatal outcome]. Leszczyńska-Gorzelak, B., Poniedziałek-Czajkowska, E., Zych, I., et al.[2017]

The addition of fetal pulse oximetry (FPO) during labor did not significantly change women's satisfaction with fetal monitoring or their overall labor experience compared to conventional monitoring methods, based on a survey of participants in the FOREMOST trial.

While women's satisfaction scores slightly declined over time, this change was similar in both the FPO and control groups, indicating that the technology did not negatively impact their perceptions of the birthing experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's evaluations of their experience in a multicenter randomized controlled trial of intrapartum fetal pulse oximetry (The FOREMOST Trial). East, CE., Chan, FY., Brennecke, SP., et al.[2007]

In a study of 1,246 high-risk pregnancies, fetal heart rate monitoring was associated with significantly lower intrapartum and early neonatal mortality rates compared to unmonitored deliveries.

The results suggest that fetal heart rate monitoring can improve outcomes for high-risk deliveries, highlighting its importance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal outcome in monitored and unmonitored high-risk deliveries. Weinraub, Z., Caspi, E., Brook, I., et al.[2006]

A new device using sensitive piezoelectric sensors effectively records fetal movements, distinguishing them from other abdominal movements like contractions and breathing.

In a study of 20 women, the device showed a high correlation with maternal perception of fetal movements, capturing 90.4% of movements compared to 79.7% reported by the women, indicating its potential for accurate monitoring during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal movements recorder, use and indications. Sadovsky, E., Polishuk, WZ., Yaffe, H., et al.[2019]

Monitoring fetal motion in high-risk pregnancies can effectively predict fetal distress and potential stillbirth, making maternal recording of fetal activity a valuable and cost-effective surveillance method.

While an active fetus is a positive sign, a lack of movement necessitates further evaluation through advanced techniques like ultrasonography and fetal heart rate testing, as some acute conditions may not be detected through motion monitoring alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implications from monitoring fetal activity. Rayburn, WF.[2019]

The prototype electronic ruler for assessing fetal heart rate (FHR) variability showed moderate reliability among expert clinicians, indicating it can be a dependable tool for monitoring FHR.

Using the electronic ruler significantly improved the accuracy of amplitude measurements compared to traditional paper strips, suggesting it could enhance the assessment of fetal heart health as reliance on paper strips decreases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of fetal heart rate variability on an electronic monitor using a prototype electronic ruler. Hall, LM., Hannon, DJ., Leisk, GG., et al.[2012]

In a study of 150 neonatal admissions, 360 adverse events were identified, affecting 52% of infants, with a high preventability rate of 84.7%, indicating significant opportunities for improving patient safety in neonatal care.

Preterm infants experienced a higher rate of adverse events compared to term infants, particularly within the first week of admission, highlighting a critical period for monitoring and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying neonatal adverse events in preterm and term infants using a paediatric trigger tool. Dillner, P., Unbeck, M., Norman, M., et al.[2023]

Fetal monitoring during pregnancy is crucial for preventing fetal death and ensuring better outcomes for both the fetus and newborns.

Understanding the goals and methods of fetal surveillance allows pediatricians to effectively communicate with obstetric teams, which can enhance the care provided during delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal assessment during pregnancy. Farley, D., Dudley, DJ.[2016]

In a study of 483 high-risk obstetric patients, electronic fetal heart rate monitoring did not show any improvement in infant outcomes compared to traditional auscultation, as measured by neonatal death, Apgar scores, and other health indicators.

However, the use of electronic monitoring was associated with a significantly higher cesarean section rate (16.5%) compared to the auscultation group (6.8%), suggesting that electronic monitoring may lead to more interventions without improving fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of continuous fetal heart rate monitoring in high-risk pregnancy. Haverkamp, AD., Thompson, HE., McFee, JG., et al.[2019]

There is often a lack of data on the safety of new drugs during pregnancy and their effects on embryo, fetal, and neonatal development when they are first launched.

To address this gap, a risk management plan must be developed and validated, involving collaboration between private and public entities to standardize data collection and improve pharmacovigilance efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and monitoring methods for the future mother, embryo, fetus, and post-natal consequences. Jacqz-Aigrain, E., Lamarque, V.[2019]

Citations

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

Effectiveness of Remote Fetal Monitoring on Maternal-Fetal ... Remote fetal monitoring seems to reduce the incidence of neonatal asphyxia and health care costs compared with routine fetal monitoring.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06726343

Maternal Fetal Device Performance Singleton This study aims to support a new maternal fetal monitoring device with clinical data to demonstrate the equivalent performance against the currently marketed ...

3. withpower.com withpower.com/trial/phase-pregnant-state-2025-2a1e7

Fetal Monitoring Device for Pregnancy The Investigational Fetal Monitor is unique because it allows for fetal monitoring from home, transmitting data quickly and accurately over standard telephone ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06835647

NCT06835647 | Maternal Fetal Device Performance Twins This study aims to support a new maternal fetal monitoring device with clinical data by collecting distinguishable FHRs from twin pregnancies using ultrasound ...

5. 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. Delay et al. 2021 [28](Tested on 120 ...

6. 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 ...

7. withpower.com withpower.com/trial/phase-pregnant-state-9-2024-0c935

Fetal Monitoring Device for Pregnancy · Info for Participants Participants undergo two 30-minute monitoring sessions using both the investigational and FDA-approved devices to collect fetal heart rate and movement data.

8. mayo.edu mayo.edu/research/clinical-trials/cls-20541016

Marani Health M Care Study - Mayo Clinic The objective of this study is to demonstrate the safety and performance of the Marani Fetal Monitoring Telehealth System (M•care™ System) for ...