Novii External Fetal Monitoring Device

Intermountain Health Care, Inc.

Status: Completed

Conditions: Pregnancy Related; Fetal Distress

Treatments: Device: Novii ECG/EKG System; Device: External fetal heart rate monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03156608

1050411

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Novii Device ECG/EMG System

Experimental group

Description:

These patients will have the Novii ECG/EMG system placed throughout labor and delivery, unless a provider or investigator determines that a different device (internal or external) is necessary for a better signal.

Treatment:

Device: Novii ECG/EKG System

Standard of Care External Monitor

Active Comparator group

Description:

A standard external monitor will be placed throughout labor and delivery, unless a provider or investigator determines that an internal device is necessary for a better signal.

Treatment:

Device: External fetal heart rate monitoring