Maternal Fetal Device Performance Twins

Part of paid clinical trials in Louisville, Colorado.

Sponsor
GE Healthcare
Study ID
NCT06835647
Status
Recruiting
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Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Investigational Fetal Monitor — DEVICE
    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.
  • Ultrasound Imaging Device — 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.

Study Details

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.

Key Dates

Start date
Jan 21, 2025
Status verified
Jul 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Twin Monitoring - All Subjects
    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, fetal lie, 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.

Primary Outcome Measure

Collection of Distinct Fetal Heart Rate [ Time Frame: 40 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Element Materials TechnologyLouisvilleColorado80027
Monica Rabanal, NP
[email protected]
303-926-5432
Monica Rabanal, NP (PRINCIPAL_INVESTIGATOR)

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Element Materials Technology· Louisville, CO

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