NCT03223324

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Monica Healthcare Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study is a single-center prospective paired comparison trial, to determine the equivalence of the Monica Novii Patch System with FDA cleared Doppler FHR, TOCO UC and photo plethysmograph MHR Predicate. Patients admitted for threatened pre-term labor and for pre-term labour \& delivery will be monitored with both devices simultaneously for FHR, UC, and MHR. Only the data from predicate devices will be available to the clinical care team. The equivalence of the Novii data will be compared to that of the simultaneously obtained predicate device data. Since TOCO UC and Doppler FHR are prone to artefact or error in a Pre-Term Labor population, the principal investigator or a member of the study team will decide on: 1. One 30 minute period of 'interpretable' Doppler FHR, photo plethysmograph MHR and TOCO UA from each of the admitted threatened pre-term labor subjects, when the subject is experiencing contractions as demonstrated by the TOCO UC trace and these contractions represent the clinical presentation. 2. One 30 minute period of 'interpretable' Doppler FHR, photo plethysmograph MHR and TOCO UA from each of the pre-term labor \& delivery subjects ending as close to delivery as practical. As above the TOCO UC contractions should represent the clinical presentation. The selection of the 30 min periods will be based on data from the predicate only (the Novii FHR and UC data will not be available to the study team). The two 30 min periods will be used for the statistical equivalence calculation. All recorded data will be made available for visual review.

Conditions

• Premature Labor

Interventions

Type	Name	Description
DEVICE	abdominal fetal/maternal monitor	A single passive patch placed on the abdomen that incorporates 5 electrodes and a monitoring device

Timeline

• Start date: 2016-07-02
• Primary completion: 2017-05-30
• Completion: 2017-05-30
• First posted: 2017-07-21
• Last updated: 2019-09-23

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study