Novii External Fetal Monitoring Device

Launched by INTERMOUNTAIN HEALTH CARE, INC. · May 16, 2017

Keywords

ClinConnect Summary

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...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant women ≥ 18 years of age; gestational age ≥ 37 weeks
• • Singleton pregnancy.
• * These women will be those presenting to Labor and Delivery for one of the following:
• • Rule out labor
• • Spontaneous labor
• • Induction of labor
• Exclusion Criteria:
• • Age \< 18 years old; multiple gestation pregnancy; gestational age \< 37 weeks
• • Fetal distress or vaginal bleeding prior to monitor placement
• • Previous cesarean section
• • Planned cesarean delivery.
• • Women who are enrolled in the study but have less than 1 hour of fetal heart rate monitoring after randomization will be excluded from analysis.