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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data to demonstrate the equivalent performance against the currently marketed Corometrics 259cx. The fetal heart rate and will be collected during antenatal monitoring using standard of care Doppler ultrasound.

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 data supports the idea that Fetal Monitoring Device for Pregnancy is an effective treatment?

The available research shows that fetal heart rate monitoring can improve outcomes in high-risk pregnancies. One study found that monitored high-risk deliveries had significantly lower rates of intrapartum and early neonatal mortality compared to unmonitored ones. However, another study found no difference in infant outcomes between monitored and unmonitored groups, but noted a higher rate of cesarean sections in the monitored group. This suggests that while fetal monitoring may help in some cases, it might not always lead to better outcomes and could increase the likelihood of cesarean deliveries. ^{1 2 3 4 5}

What safety data exists for the fetal monitoring device used in pregnancy?

The safety data for the fetal monitoring device is not explicitly detailed in the provided research. However, the research highlights the importance of developing standard definitions and grading for maternal and fetal adverse events to improve safety monitoring in pregnancy trials. It also discusses the need for better safety evaluation processes for non-active implantable medical devices (NAIMDs), like fetal monitoring devices, compared to medicines. The research suggests that adopting certain drug safety evaluation features could enhance the systematic evaluation of NAIMDs. Additionally, the importance of post-market surveillance and risk management plans for assessing risks associated with new medical products, including fetal monitoring devices, is emphasized. ^{6 7 8 9 10}

Is the Investigational Fetal Monitoring Device a promising treatment for pregnancy?

Yes, the Investigational Fetal Monitoring Device is promising because it can continuously monitor the baby's heart rate and movements, providing important information about the baby's health. This helps doctors detect any problems early and take action to keep both the mother and baby safe. ^{11 12 13 14 15}

Research Team

Monica Rabanal, NP, Medical Director

Principal Investigator

Element Materials Technology

Eligibility Criteria

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

Multiple pregnancy

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fetal assessment during pregnancy. [2016]

2. Poland pubmed.ncbi.nlm.nih.gov

[The usefulness of the intrapartum fetal pulse oximetry in anticipating the neonatal outcome]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

The evaluation of continuous fetal heart rate monitoring in high-risk pregnancy. [2019]

4. United States 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). [2007]

5. Israel pubmed.ncbi.nlm.nih.gov

Perinatal outcome in monitored and unmonitored high-risk deliveries. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Sources of Safety Data and Statistical Strategies for Design and Analysis: Postmarket Surveillance. [2020]

9. France pubmed.ncbi.nlm.nih.gov

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

10. Norway pubmed.ncbi.nlm.nih.gov

Identifying neonatal adverse events in preterm and term infants using a paediatric trigger tool. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Measurement of fetal heart rate variability on an electronic monitor using a prototype electronic ruler. [2012]

12. United States pubmed.ncbi.nlm.nih.gov

Fetal movements recorder, use and indications. [2019]

13. Ireland pubmed.ncbi.nlm.nih.gov

A CNN-RNN unified framework for intrapartum cardiotocograph classification. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

A systematic scoping review to identify the design and assess the performance of devices for antenatal continuous fetal monitoring. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Clinical implications from monitoring fetal activity. [2019]