Clinical trial NCT03223324: Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour
Official title: Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Labor
Keywords: Threatened Premature Labor
Abdominal Fetal ECG
Lead sponsor: Monica Healthcare Ltd
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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. In addition, subjects admitted for pre-term labor \& delivery (total of 30 subjects) will be recruited. following the same stratification plan as above.

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

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.

Eligibility 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.

Primary outcomes:
measure: FHR Deming Regression
timeFrame: 30min
Secondary outcomes:
measure: FHR Percent Agreement
timeFrame: 30min
measure: FHR Bland Altman
timeFrame: 30min
measure: MHR Percent agreement
timeFrame: 30min
measure: MHR bland altman
timeFrame: 30min
measure: UC percent agreement
timeFrame: 30min
measure: UC Positive percent agreement
timeFrame: 30min
measure: MHR deming regression
timeFrame: 30min
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale dei Bambini Vittore Buzzi, Via Lodovico Castelvetro, 32
Study officials:
affiliation: l'Università degli Studi di Milano
name: Enrico Ferrazzi, Professor
role: PRINCIPAL_INVESTIGATOR
References: