Premature Labor Clinical Trial
Official title:
Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour
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
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.
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