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

NCT03057275 | Completed FDA Device

• 1 other identifier: 107-CT-007rev10_UAMC
• Study Type: observational
• Target: 47
• 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 (8)

• 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).

  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

• 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

• 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: "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).

  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: "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.

  30min

• MHR percent agreement

  As for FHR

  30min

• MHR bland altman

  As for FHR

  30min

• MHR deming regression

  As for FHR

  30min

Study Arms (2)

Threatened PTL

abdominal fetal/maternal monitoring

Device: Abdominal fetal/maternal monitoring

Delivered PTL

abdominal fetal/maternal monitoring

Device: Abdominal fetal/maternal monitoring

Interventions

Abdominal fetal/maternal monitoring DEVICE

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

Also known as: Novii Wireless Patch System

Delivered PTL; Threatened PTL

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 Subjects admitted for pre-term labor \& delivery (total of 30 subjects) will be recruited for the study 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

• GE Healthcare: lead

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Gonzalez M, Hill M, Cohen WR. Performance of a Maternal Abdominal Surface Electrode System for Fetal Heart Rate and Uterine Contraction Monitoring from 34 to 37 Weeks. Am J Perinatol. 2024 Feb;41(3):263-269. doi: 10.1055/a-1673-1765. Epub 2021 Oct 19.

  PMID: 34666382 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

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

Study Officials

• Megahan G Hill, MBBS

  Banner- University of Arizona Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: April 20, 2017
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)