NCT03409146

Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)

Accuracy and Reliability of a New Intrapartum Fetal Heart Rate, Maternal Heart Rate, and Uterine Contraction Monitoring Method Compared With Food and Drug Administration (FDA) Approved Techniques.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques

Detailed description

The study is being done to test the performance of a Novii Wireless Patch System for following the baby's and mother's heart rates and uterine contractions during labor. We want to find out if the new monitor works as well as other types of monitors that are usually used: Doppler Fetal Heart Rate (FHR), Scalp FHR, Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC). 80 patients will be monitored during the study.

Conditions

• Term Labour

Interventions

Type	Name	Description
DEVICE	Monica Novii Wireless Patch System	The Monica Novii Wireless Patch System is a transabdominal fetal/maternal recorder that provides fetal heart rate, maternal heart rate and maternal uterine activity contractions.

Timeline

• Start date: 2014-05-28
• Primary completion: 2017-02-13
• Completion: 2017-02-13
• First posted: 2018-01-24
• Last updated: 2021-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study