Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring
GE Healthcare
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.
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Able and willing to provide written informed consent. 2. Twin pregnancy. 3. Aged 18+. 4. Greater than or equal to 30 0/7 weeks gestation. 5. Patient has none of the exclusion criteria. Exclusion Criteria: 1. Non-twin pregnancy. 2. Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study. 3. Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study. 4. Inability to understand the consent information due to med…
Interventions
- DeviceInvestigational Fetal Monitor
Investigational Fetal Monitoring Device Device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.
- DeviceUltrasound Imaging Device
The Ultrasound imaging device is a general-purpose diagnostic ultrasound system for use in measurement, display and analysis of the human body and fluid.
Location
- Element Materials TechnologyLouisville, Colorado