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Performance of the Monica Novii Wireless Patch System in Pre-term Labor

NCT03057275 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2021-02-09

No results posted yet for this study

Summary

To study the equivalence of the Monica Novii™ Patch System in patients admitted for threatened pre-term labor and for pre-term labor \& delivery from 32 +0 weeks gestation by determining the equivalence of the Novii™ Patch System in monitoring Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contractions (UC) to Doppler FHR, tocodynamometer (TOCO) UC and photo plethysmograph MHR FDA approved predicates.

Conditions

  • Premature Labor

Interventions

DEVICE

Abdominal fetal/maternal monitoring

A single patch placed on the abdomen that incorporates 5 electrodes and a monitoring device

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Megahan G Hill, MBBS · Banner- University of Arizona Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2019-09-20
Completion
2019-09-20
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 NCT03057275 on ClinicalTrials.gov