Premature LaborNCT03223324

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

An observational study of Premature Labor, run by Monica Healthcare Ltd at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Premature Labor
What is being tested?: abdominal fetal/maternal monitor
Type of treatment: Medical device
How many people: 31 participants
Where: 1 siteItaly
Study dates: 2 Jul 2016to 30 May 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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).

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale dei Bambini Vittore Buzzi, Via Lodovico Castelvetro, 32
Milan, 20154

Other trials in Italy

About this study

Read the 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:

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.
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
Being tested: abdominal fetal/maternal monitor
Keywords: Threatened Premature Labor, Abdominal Fetal ECG
Medical subject headings: Obstetric Labor, Premature

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

abdominal fetal/maternal monitorDevice
Also called Novii Wireless Patch System
A single passive patch placed on the abdomen that incorporates 5 electrodes and a monitoring device

Study groups in NCT03223324
Study group	Role	What they receive
Pre Term and Threatened Pre-Term Labor		abdominal fetal/maternal monitoring Receives: Device: abdominal fetal/maternal monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 30min

Secondary outcomes (7)

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).
Measured: 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.
Measured: 30min
MHR Percent agreement
As for FHR
Measured: 30min
MHR bland altman
As for FHR
Measured: 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 "uninterpretable".
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).
Measured: 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.
Measured: 30min
MHR deming regression
As for FHR deming regression
Measured: 30min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 201630 May 2017

First posted21 Jul 2017
Study start2 Jul 2016
Primary completion30 May 2017
Study completion30 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Premature LaborStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03223324
Sponsor's protocol ID: 107-CT-007-Buzzi
Status last verified: Sep 2019
First submitted: 4 May 2017
Last updated: 23 Sep 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Premature Labor trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of the Monica Novii Wireless Patch System in Threatened and Actual Pre-Term Labour
ClinicalTrials.gov ID: NCT03223324
Acronym / sponsor ID: 107-CT-007-Buzzi
Conditions: Premature Labor
Keywords: Threatened Premature Labor, Abdominal Fetal ECG
Study type: Observational
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Monica Healthcare LtdIndustry (pharma, biotech, devices)
Study start: 2 Jul 2016 (actual)
Primary completion: 30 May 2017 (actual)
Study completion: 30 May 2017 (actual)
First posted: 21 Jul 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.
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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pre Term and Threatened Pre-Term Labor	–	Device: abdominal fetal/maternal monitorabdominal fetal/maternal monitoring

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
abdominal fetal/maternal monitorAlso: Novii Wireless Patch SystemA single passive patch placed on the abdomen that incorporates 5 electrodes and a monitoring device	Device	Pre Term and Threatened Pre-Term Labor

Primary outcome

FHR Deming Regression
Time frame: 30min
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).

7 secondary outcomes

FHR Percent Agreement
Time frame: 30min
FHR Bland Altman
Time frame: 30min
MHR Percent agreement
Time frame: 30min
MHR bland altman
Time frame: 30min
UC percent agreement
Time frame: 30min
UC Positive percent agreement
Time frame: 30min
MHR deming regression
Time frame: 30min

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
Individual participant dataSharing planned: No

Related trials for Premature Labor

Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
RecruitingObservational study
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Recruiting
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Enrico Ferrazzi, Professor principal investigator

l'Università degli Studi di Milano

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Premature Labor, run by Monica Healthcare Ltd at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FHR Deming Regression (time frame: 30min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.