15 Participants Needed

Fetal Monitoring Device for Pregnancy

AR
Overseen ByAmie Research Program Integrator
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: GE Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.1112131415

Who Is on the Research Team?

MR

Monica Rabanal, NP

Principal Investigator

Element Materials Technology

Are You a Good Fit for This Trial?

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
See 1 more

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
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Twin Monitoring - All SubjectsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials
307
Recruited
634,000+
Fotis Vlachos profile image

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 profile image

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

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.
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.
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.
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]

Citations

The evaluation of continuous fetal heart rate monitoring in high-risk pregnancy. [2019]
Fetal assessment during pregnancy. [2016]
Current status of the multicenter randomized clinical trial on fetal oxygen saturation monitoring in the United States. [2019]
Women's evaluations of their experience in a multicenter randomized controlled trial of intrapartum fetal pulse oximetry (The FOREMOST Trial). [2007]
Wearable Fetal Monitoring Solution for Improved Mobility During Labor & Delivery. [2020]
A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. [2019]
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]
[Drug safety in pregnancy-a particular challenge]. [2019]
An alternative to product-specific pregnancy registries? PRIM; PRegnancy outcomes Intensive Monitoring. [2021]
Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance. [2021]
A CNN-RNN unified framework for intrapartum cardiotocograph classification. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Measurement of fetal heart rate variability on an electronic monitor using a prototype electronic ruler. [2012]
13.United Statespubmed.ncbi.nlm.nih.gov
The nonstress test. Transmission from the home. [2004]
[Clinical experience of long-distance electronic fetal heart rate monitoring system by telephone]. [2006]
New instrument developments for fetal pH monitoring. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security