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Novii External Fetal Monitoring Device

NCT03156608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2017-11-01

No results posted yet for this study

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.

Conditions

  • Pregnancy Related
  • Fetal Distress

Interventions

DEVICE

Novii ECG/EKG System

External fetal heart rate monitoring

DEVICE

External fetal heart rate monitoring

External fetal heart rate monitoring

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Intermountain Health Care, Inc.

    lead OTHER

Principal Investigators

  • Michael S Esplin, MD · Staff Physician

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2017-06-28
Completion
2017-06-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156608 on ClinicalTrials.gov