Fetal Monitoring Device for Pregnancy
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?
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Monitoring Session
Pregnant women of ≥30 0/7 weeks gestation undergo a 40-minute monitoring session using the investigational device with Doppler transducers
Follow-up
Participants are monitored for safety and effectiveness after the monitoring session
What Are the Treatments Tested in This Trial?
Interventions
- Investigational Fetal Monitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
GE Healthcare
Lead Sponsor
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