NCT06835647

Maternal Fetal Device Performance Twins

Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	Investigational 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.
DEVICE	Ultrasound 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.

Timeline

• Start date: 2025-01-21
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2025-02-19
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study