Testing a New Maternal Fetal Monitoring Device Using Ultrasound Doppler to Track Twin Pregnancies For Pregnant Women at 30 Weeks or More

What this Trial Is About

This research investigates a new maternal fetal monitoring device designed to assist healthcare professionals in tracking fetal and maternal health during twin pregnancies. The study aims to collect clinical data by continuously monitoring and distinguishing fetal heart rates FHRs from twins using ultrasound Doppler transducers from both the investigational device and a marketed ultrasound imaging device. This helps support clinical decisions regarding fetal health during pregnancy and delivery. Pregnant women with twin pregnancies at 30 weeks gestation or later will participate in a single 40-minute monitoring session. During this session, the investigational device uses two Doppler transducers to capture fetal heart rates for each twin after confirming fetal presentation and positions by ultrasound imaging. Maternal pulse rate is also monitored using a SpO2 sensor, and investigators will adjust the transducers as needed to maintain continuous data collection. Participants will undergo this monitoring session while researchers collect fetal heart rate data and maternal pulse rates. The primary outcomes measured are the collection of distinct fetal heart rates and maternal pulse rates over 40 minutes. Safety events will be tracked for four months after participation. This study is sponsored by GE Healthcare and does not include patient advisors.

Maternal Fetal Device Performance Twins