Novii External Fetal Monitoring Device

Completed · Not applicable

Conditions studied: Pregnancy Related, Fetal Distress

In brief

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.

Key facts

Study ID

NCT03156608

Run by

Intermountain Health Care, Inc.

People needed

218

Starts

2017-03-06

Expected to finish

2017-06-28

Last updated by the study team

2017-11-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Intermountain Medical Center — Murray, Utah, United States
• McKay-Dee Hospital — Ogden, Utah, United States
• Utah Valley Hospital — Provo, Utah, United States
• LDS Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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