NCT03156608

Novii External Fetal Monitoring Device

Evaluation of the Novii External Fetal Monitoring Device: A Prospective, Randomized Comparison

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted on women in labor. Fetal heart rate monitoring will be conducting using the Novii Fetal ECG/EMG system and comparing it to current standard of care external fetal heart rate and tocometry. These approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.

Detailed description

Interpretation of fetal heart rate monitoring during labor is one of the most common procedures performed in the practice of obstetrics. Continuous monitoring of the fetal heart rate is used to identify infants at risk for hypoxic ischemic encephalopathy and allow for intervention to prevent this terrible complication. The quality of the fetal heart rate signal is critical for appropriate interpretation of the characteristics that identify risk. This is a prospective, randomized pragmatic trial comparing the Novii Fetal ECG/EMG system to external fetal heart rate and tocometry (standard of care) for the amount of time of interpretable fetal heart rate during labor. Randomization will occur in blocks based on BMI to control for the potential effect of BMI. Fetal heart rate tracings from both groups of women will be reviewed in a blinded fashion by experienced Maternal Fetal Medicine (MFM) physicians who will assess the tracing for quality and interpretability. In addition, both approaches will be compared with respect to the need for additional monitoring modalities, amount of nursing intervention, cost and satisfaction of the patients and healthcare providers.

Conditions

• Pregnancy Related
• Fetal Distress

Interventions

Type	Name	Description
DEVICE	Novii ECG/EKG System	External fetal heart rate monitoring
DEVICE	External fetal heart rate monitoring	External fetal heart rate monitoring

Timeline

• Start date: 2017-03-06
• Primary completion: 2017-06-28
• Completion: 2017-06-28
• First posted: 2017-05-17
• Last updated: 2017-11-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study