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Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour

NCT03223324 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2019-09-23

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 monitor

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

Sponsors & Collaborators

  • Monica Healthcare Ltd

    lead INDUSTRY

Principal Investigators

  • Enrico Ferrazzi, Professor · l'Università degli Studi di Milano

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-02
Primary Completion
2017-05-30
Completion
2017-05-30
FDA Device
Yes

Countries

  • Italy

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 NCT03223324 on ClinicalTrials.gov