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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:
All recorded data will be made available for visual review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre Term and Threatened Pre-Term Labor | abdominal fetal/maternal monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abdominal fetal/maternal monitor | Device | A single passive patch placed on the abdomen that incorporates 5 electrodes and a monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 30min |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following factors or conditions would exclude the patient from consideration as a subject:
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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. In addition, subjects admitted for pre-term labor & delivery (total of 30 subjects) will be recruited. following the same stratification plan as above.
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| Name | Affiliation | Role |
|---|---|---|
| Enrico Ferrazzi, Professor | l'Università degli Studi di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale dei Bambini Vittore Buzzi, Via Lodovico Castelvetro, 32 | Milan | 20154 | Italy |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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. | 30min |
| MHR Percent agreement | As for FHR | 30min |
| MHR bland altman | As for FHR | 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:
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 |
| 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:
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 |
| MHR deming regression | As for FHR deming regression | 30min |