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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057275
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Monica Healthcare Ltd

Brief 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.

Condition or disease Intervention/treatment
Premature Labor Device: Abdominal fetal/maternal monitoring

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.

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance of the Monica Novii Wireless Patch System in Pre-term Labor
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019

Group/Cohort Intervention/treatment
Threatened PTL
abdominal fetal/maternal monitoring
Device: Abdominal fetal/maternal monitoring
A single patch placed on the abdomen that incorporates 5 electrodes and a monitoring device
Other Name: Novii Wireless Patch System

Delivered PTL
abdominal fetal/maternal monitoring
Device: Abdominal fetal/maternal monitoring
A single patch placed on the abdomen that incorporates 5 electrodes and a monitoring device
Other Name: Novii Wireless Patch System




Primary Outcome Measures :
  1. FHR Percent Agreement [ Time Frame: 30min ]
    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).

  2. FHR Bland Altman [ Time Frame: 30min ]
    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.

  3. FHR Deming Regression [ Time Frame: 30min ]
    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).

  4. UC percent agreement [ Time Frame: 30min ]

    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).


  5. UC Positive percent agreement [ Time Frame: 30min ]

    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.


  6. MHR percent agreement [ Time Frame: 30min ]
    As for FHR

  7. MHR bland altman [ Time Frame: 30min ]
    As for FHR

  8. MHR deming regression [ Time Frame: 30min ]
    As for FHR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects admitted for threatened pre-term labor (total of 30 subjects) will be recruited for the study according to the following strata:

  • 15 patients with a gestation equal to 32 weeks +0 days gestation but < 34 weeks +4 days
  • 5 patients with a Body Mass Index (BMI) less than 29
  • 5 patients with a BMI equal to 29 but less than 35
  • 5 patients with a BMI equal to or more than 35
  • 15 patients with a gestation equal to 34 weeks +4 days gestation but < 37 weeks +0 days
  • 5 patients with a BMI less than 29
  • 5 patients with a BMI equal to 29 but less than 35
  • 5 patients with a BMI equal to or more than 35

Subjects admitted for pre-term labor & delivery (total of 30 subjects) will be recruited for the study following the same stratification plan as above.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057275


Locations
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United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Monica Healthcare Ltd
Investigators
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Principal Investigator: Megahan G Hill, MBBS Banner- University of Arizona Medical Center
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Responsible Party: Monica Healthcare Ltd
ClinicalTrials.gov Identifier: NCT03057275    
Other Study ID Numbers: 107-CT-007rev10_UAMC
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Monica Healthcare Ltd:
Threatened Premature Labor
Abdominal Fetal ECG
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications