Fetal Monitoring Device for Pregnancy

Overseen By Amie Research Program Integrator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: GE Healthcare

Disqualifiers: Non-twin pregnancy, others

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

Compensation: Varies

Number of Visits: 1

15 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 support clinical decision making for pregnant women and assesses the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data by collecting simultaneous, continuous, external, distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the new maternal fetal monitoring investigational device and a marketed ultrasound imaging device.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Investigational Fetal Monitor?

Research on fetal pulse oximetry, a similar technology, shows it can improve the assessment of fetal well-being during labor. Additionally, a new wireless fetal monitoring system has been developed to improve comfort and mobility while accurately capturing fetal heart rate and uterine activity. ^{1 2 3 4 5}

Is the fetal monitoring device generally safe for use in humans?

The FDA requires premarket approval for obstetric devices like fetal monitors to ensure they meet safety standards, which helps reduce the risk of illness or injury during use. ^{6 7 8 9 10}

How is the Investigational Fetal Monitor different from other fetal monitoring treatments?

The Investigational Fetal Monitor is unique because it allows for fetal monitoring from home, transmitting data quickly and accurately over standard telephone lines, which is not a feature of traditional hospital-based monitors. This enables immediate interpretation by experts without the need for hospital visits, making it more convenient for pregnant women. ^{11 12 13 14 15}

Research Team

Monica Rabanal, NP

Principal Investigator

Element Materials Technology

Eligibility Criteria

This trial is for pregnant women carrying twins. It's designed to test a new fetal monitoring device that tracks the health of both babies and the mother during pregnancy and delivery.

Inclusion Criteria

Greater than or equal to 30 0/7 weeks gestation

Twin pregnancy

Patient has none of the exclusion criteria

Exclusion Criteria

Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study

Non-twin pregnancy

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 Session

Pregnant women of ≥30 0/7 weeks gestation undergo a 40-minute monitoring session using the investigational device with Doppler transducers

40 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the monitoring session

4 months

Treatment Details

Interventions

• Investigational Fetal Monitor

Trial Overview The study compares a new investigational fetal monitor with an existing ultrasound imaging device, focusing on their ability to continuously track heart rates in twin pregnancies using ultrasound Doppler transducers.

Participant Groups

Group I: Twin Monitoring - All Subjects Experimental Treatment 2 Interventions

Pregnant women of ≥30 0/7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation, fetal lie, visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.

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

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]

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]

A multicenter randomized clinical trial is underway in the US to evaluate the safety and efficacy of using pulse oximeters for monitoring fetal oxygen saturation during labor, addressing the limitations of current fetal assessment methods.

This trial aims to provide a more accurate assessment of fetal compromise, potentially reducing the high cesarean section rates associated with less specific current methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of the multicenter randomized clinical trial on fetal oxygen saturation monitoring in the United States. Dildy, GA., Clark, SL., Garite, TJ., 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]

A new wireless electronic fetal monitoring (EFM) system was developed using wearable devices that improve patient comfort and mobility during labor and delivery, eliminating the need for cables and belts.

Benchtop testing showed that these wearable devices can accurately measure fetal heart rate and uterine activity, providing reliable signal capture even when the mother moves or changes position.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Fetal Monitoring Solution for Improved Mobility During Labor & Delivery. Nguyen, K., Bamgbose, E., Cox, BP., et al.[2020]

Effective clinical drug safety surveillance is crucial for protecting public health and ensuring the commercial success of pharmaceutical products, as it helps monitor and manage adverse drug events.

The process of drug safety surveillance is governed by FDA regulations and involves systematic management of adverse event reports, emphasizing the importance of clear communication and data handling to improve drug safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. Allan, MC.[2019]

The FDA is now requiring premarket approval applications for obstetric data analyzers, which are class III medical devices that monitor fetal and maternal data during labor to detect potential fetal distress.

This regulation aims to ensure that these devices meet safety and efficacy standards, thereby reducing the risk of illness or injury associated with their use and enhancing public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical devices; effective date of requirement for premarket approval for a class III preamendments obstetrical and gynecological device. Food and Drug Administration, HHS. Final rule. [2004]

Observational data, particularly from the German Embryotox institute, are crucial for assessing drug safety in pregnancy, as they help estimate relative risks for birth defects and other developmental issues through prospective cohort studies.

Effective drug counseling during pregnancy requires individualized risk assessments and the integration of high-quality data on pregnancy outcomes after drug exposure, as demonstrated with examples like acetaminophen and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug safety in pregnancy-a particular challenge]. Schaefer, C.[2019]

The PRegnancy outcomes Intensive Monitoring (PRIM) method successfully identified 831 prospective maternal exposures to fingolimod during pregnancy, significantly increasing the number of reported cases compared to traditional pregnancy registries.

This approach allowed for the collection of detailed pregnancy outcome data, enabling the calculation of major congenital malformations and other outcomes, thus enhancing the understanding of the safety of fingolimod for pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative to product-specific pregnancy registries? PRIM; PRegnancy outcomes Intensive Monitoring. Geissbühler, Y., Rezaallah, B., Moore, A.[2021]

Real-world data on the safety of psychotropic drugs during pregnancy is becoming increasingly important for understanding their effects on maternal and fetal health, despite the limitations of observational studies.

The integration of real-world safety data into regulatory decision-making, exemplified by the safety assessment of sodium valproate, marks a significant shift towards modern pregnancy pharmacovigilance, improving drug labeling and safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance. Lupattelli, A., Spigset, O., Nordeng, H.[2021]

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]

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]

The Genesis Fetal Monitor System allows for accurate and rapid transmission of fetal monitoring data over standard telephone lines, with a transmission time of less than 2 minutes for a 20-minute nonstress test.

The system enables fetal assessments to be conducted outside of hospital settings, such as at home, while providing immediate interpretation by skilled consultants, ensuring timely and effective monitoring of fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nonstress test. Transmission from the home. Acker, DB., Corwin, M., Sachs, BP., et al.[2004]

The study involved 204 high-risk pregnant women, with 97 using a long-distance electronic fetal heart rate monitoring system at home, which allowed them to monitor their baby's heart rate and contact a hospital if abnormalities were detected.

Using this monitoring system significantly reduced the incidence of neonatal asphyxia and improved perinatal care quality, despite a higher rate of abnormal non-stress tests and Apgar scores in the study group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical experience of long-distance electronic fetal heart rate monitoring system by telephone]. Pan, J., Ye, M., Du, X.[2006]

Recent upgrades to the ROCHE fetal pH monitor have made it easier to use and have increased the accuracy of recordings, which is crucial for monitoring fetal health during labor.

Key improvements include a new spiral electrode for better stabilization, enhanced tools for incision and application, and a system that minimizes handling of the pH electrode, all contributing to more reliable fetal pH measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New instrument developments for fetal pH monitoring. Hochberg, HM.[2019]

References

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

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

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

Fetal assessment during pregnancy. [2016]

3. Ireland pubmed.ncbi.nlm.nih.gov

Current status of the multicenter randomized clinical trial on fetal oxygen saturation monitoring in the United States. [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. United States pubmed.ncbi.nlm.nih.gov

Wearable Fetal Monitoring Solution for Improved Mobility During Labor & Delivery. [2020]

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

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. [2019]

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

Medical devices; effective date of requirement for premarket approval for a class III preamendments obstetrical and gynecological device. Food and Drug Administration, HHS. Final rule. [2004]

8. Germany pubmed.ncbi.nlm.nih.gov

[Drug safety in pregnancy-a particular challenge]. [2019]

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

An alternative to product-specific pregnancy registries? PRIM; PRegnancy outcomes Intensive Monitoring. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

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

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

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

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

The nonstress test. Transmission from the home. [2004]

14. China pubmed.ncbi.nlm.nih.gov

[Clinical experience of long-distance electronic fetal heart rate monitoring system by telephone]. [2006]

15. Germany pubmed.ncbi.nlm.nih.gov

New instrument developments for fetal pH monitoring. [2019]