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

NCT ID: NCT03223324

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-02
• Study Completion Date: 2017-05-30

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.

Conditions

Premature Labor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre Term and Threatened Pre-Term Labor

abdominal fetal/maternal monitoring

abdominal fetal/maternal monitor

Intervention Type: DEVICE

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

Interventions

abdominal fetal/maternal monitor

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

Intervention Type: DEVICE

Other Intervention Names

Novii Wireless Patch System

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Monica Healthcare Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrico Ferrazzi, Professor

Role: PRINCIPAL_INVESTIGATOR

l'Università degli Studi di Milano

Locations

Ospedale dei Bambini Vittore Buzzi, Via Lodovico Castelvetro, 32

Milan, , Italy

Countries

Italy

Other Identifiers

107-CT-007-Buzzi

Identifier Type: -

Identifier Source: org_study_id