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

NCT03223324 | Completed FDA Device

• 1 other identifier: 107-CT-007-Buzzi
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Premature Labor

Keywords

Threatened Premature Labor; Abdominal Fetal ECG

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• FHR Percent Agreement

  30min

• FHR Bland Altman

  30min

• MHR Percent agreement

  30min

• MHR bland altman

  30min

• UC percent agreement

  30min

Study Arms (1)

Pre Term and Threatened Pre-Term Labor

abdominal fetal/maternal monitoring

Device: abdominal fetal/maternal monitor

Interventions

abdominal fetal/maternal monitor DEVICE

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

Also known as: Novii Wireless Patch System

Pre Term and Threatened Pre-Term Labor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• She will require pre-term labor (at least 32 weeks 0 days gestation) monitoring with a singleton longitudinal, breech, transverse lie pregnancy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monica Healthcare Ltd: lead

Study Sites (1)

Ospedale dei Bambini Vittore Buzzi, Via Lodovico Castelvetro, 32

Milan, 20154, Italy

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Enrico Ferrazzi, Professor

  l'Università degli Studi di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: July 21, 2017
• Study Start: July 2, 2016
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)