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

GE Healthcare47 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Premature Labor

Interventions

Abdominal fetal/maternal monitoringDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * She will require pre-term labor (at least 32 weeks 0 days gestation) monitoring with a singleton longitudinal, breech, transverse lie pregnancy. * She had none of the exclusion criteria. Exclusion Criteria: The presence of any of the following factors or conditions would exclude the patient from consideration as a subject: * Known major fetal malformation or chromosome abnormality. * Multiple gestation * A condition for which cesarean will likely be carried out shortly. * Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study. * Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, history of sensitivity to adhesives). * Parturient is under age 18. * Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study. * Inability to understand the consent information due to medical illness or diminished intellectual capacity, or insurmountable language barrier. * Potential for coercion, e.g. Prisoners.

Locations (1)

University of Arizona Medical Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

FHR Percent Agreement

The fetal heart rate output file from the predicate device is processed to generate a time line plot of FHR data in which the epochs with un-interpretable data (e.g. no FHR value in that 2 second window) are removed to create "interpretable" only FHR data, i.e. the predicate is represented as 100% successful. A corresponding Monica Novii file is then generated that has the same time epochs as the Doppler FHR data set but containing the Novii FHR data or uninterpretable data (i.e. no FHR value).

Time frame: 30min

FHR Bland Altman

Bland-Altman plots will be provided separately for each subject, together with an overall assessment using all available data from all subjects. For this overall assessment, the hierarchical nature of the dataset will be taken into account in the statistical analysis. An appropriate statistical approach is described by Bland and Altman , although in practice the analysis may also be accomplished by using a mixed model method.

Time frame: 30min

FHR Deming Regression

Standard linear regression of y on x is not appropriate in this situation as the predicate device is not considered a gold standard, but as a device providing a measurement which may itself be subject to error, whereas the standard linear regression method assumes x to be measured without error. Deming regression is a method for calculating the regression line y=α+βx when both variables are subject to error, and the ratio of the error variances in x and y is known (and will be assumed to be equal to 1 in this analysis).

Time frame: 30min

UC percent agreement

The positive percentage agreement (PA) is determined separately for each subject from the interpretable and uninterpretable data as follows: PA (%)=(a/(a+C))×100 Equation 3 Where: "a" is the number of minutes when both the Monica Novii Pod/Patch and the predicate devices are "interpretable" at the same time "c" is the number of minutes when the Predicate is "interpretable" but the Monica Novii Pod/Patch is "un-interpretable". This can be alternatively described as using only those times when the Predicate device gives "Interpretable" data, and is defined as the percentage of those times for which the Monica Novii Pod/Patch also gives "Interpretable" data (i.e. it is analogous to sensitivity but based on reliability).

Data from ClinicalTrials.gov

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