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

Premature Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223324
• Other study ID #: 107-CT-007-Buzzi
• Status: Completed
• Start date: July 2, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: September 2019
• Source: Monica Healthcare Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Labor

Intervention

Device:
• abdominal fetal/maternal monitor
A single passive patch placed on the abdomen that incorporates 5 electrodes and a monitoring device

Locations

Country	Name	City	State
Italy	Ospedale dei Bambini Vittore Buzzi, Via Lodovico Castelvetro, 32	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Monica Healthcare Ltd

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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=a+ßx 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).	30min
Secondary	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).	30min
Secondary	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.	30min
Secondary	MHR Percent agreement	As for FHR	30min
Secondary	MHR bland altman	As for FHR	30min
Secondary	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 "uninterpretable".; 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).	30min
Secondary	UC Positive percent agreement	The Positive Percent Agreement PPA of the Novii System against the Predicate will be determined from the "individual contraction "detection as follows: PPA(%)=(x/(x+z))×100 Equation 4; Where: x" is the total number of "individual contractions" detected by BOTH the Novii Pod/PATCH and the Predicate; z" is the total number of "individual contractions" detected by the Predicate only.; Again the test for statistical non-inferiority of percent agreement based on individual uterine contractions will be defined as in Equation 2 for a one-sided 95% confidence interval using t=1.70.	30min
Secondary	MHR deming regression	As for FHR deming regression	30min