Maternal Fetal Device Performance Twins
Start Date
1/21/2025
Completion Date
12/31/2025
Summary
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.
Detailed Description
This study aims to support a new maternal fetal monitoring device with clinical data by collecting distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the investigational device and a marketed ultrasound imaging device. This study will collect twin fetal heart rate data from the new monitor on twin gestations. Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Investigational Fetal Monitor
Ultrasound Imaging Device
Conditions
Locations
Element Materials Technology
Louisville, Colorado 80027
United States