Maternal Fetal Device Performance Twins

General Electric (GE)

Status: Enrolling

Conditions: Pregnancy

Treatments: Device: Investigational Fetal Monitor; Device: Ultrasound Imaging Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06835647

SA-000073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 medical illness, diminished intellectual capacity, or insurmountable language barrier.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Twin Monitoring - All Subjects

Experimental group

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, 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.

Treatment:

Device: Ultrasound Imaging Device

Device: Investigational Fetal Monitor