Pregnancy
Conditions
Keywords
Pregnancy, Twins
Brief 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.
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.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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 (i.e. vertex, breech, shoulder), fetal lie (i.e. longitudinal, transverse), 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Distinct Fetal Heart Rate | 40 minutes | Collection of simultaneous, distinct fetal heart rate from SpO2 data from one investigational device over a 40 minutes of continuous fetal monitoring. |
| Collection of Maternal Pulse Rate | 40 minutes | Collection of maternal pulse rate from SpO2 data from one investigational device over a 40 minutes of continuous fetal monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Safety Events | 4 months | Analysis of adverse events will be listed per subject, summarized with counts and percentages of events, and summarized with counts and percentages of subjects with events. |
Countries
United States
Contacts
Primary ContactAmie Research Program Integrator
Outcome results
None listed