Premature LaborNCT03057275
Performance of the Monica Novii Wireless Patch System in Pre-term Labor
An observational study of Premature Labor, run by GE Healthcare at 1 site in United States.
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 monitoring
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2017to 20 Sep 2019
- 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 Subjects admitted for pre-term labor \& delivery (total of 30 subjects) will be recruited for the study 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).
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- 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.
United States1 site
University of Arizona Medical Center
Tucson, Arizona, 85724
About this study
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.
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 monitoring
- 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 monitoringDevice
Also called Novii Wireless Patch System
A single patch placed on the abdomen that incorporates 5 electrodes and a monitoring device
| Study group | Role | What they receive |
|---|---|---|
| Threatened PTL | abdominal fetal/maternal monitoring Receives: Device: Abdominal fetal/maternal monitoring | |
| Delivered PTL | abdominal fetal/maternal monitoring Receives: Device: Abdominal fetal/maternal monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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).
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 percent agreement
As for FHR
Measured: 30min
MHR bland altman
As for FHR
Measured: 30min
MHR deming regression
As for FHR
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start20 Apr 2017
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature LaborStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Megahan G Hill, MBBS, Principal investigator, Banner- University of Arizona Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057275
- Sponsor's protocol ID
- 107-CT-007rev10_UAMC
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2017
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34666382
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Monica Novii Wireless Patch System in Pre-term Labor
- ClinicalTrials.gov ID
- NCT03057275
- Acronym / sponsor ID
- 107-CT-007rev10_UAMC
- Conditions
- Premature Labor
- Keywords
- Threatened Premature Labor, Abdominal Fetal ECG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 20 Feb 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.
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:
- 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Threatened PTL | – | Device: Abdominal fetal/maternal monitoringabdominal fetal/maternal monitoring |
| Delivered PTL | – | Device: Abdominal fetal/maternal monitoringabdominal 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 Subjects admitted for pre-term labor \& delivery (total of 30 subjects) will be recruited for the study 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 monitoringAlso: Novii Wireless Patch SystemA single patch placed on the abdomen that incorporates 5 electrodes and a monitoring device | Device | Delivered PTL, Threatened PTL |
Primary outcome
FHR Percent Agreement
Time frame: 30min
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).
FHR Bland Altman
Time frame: 30min
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.
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).
UC percent agreement
Time frame: 30min
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).
UC Positive percent agreement
Time frame: 30min
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.
MHR percent agreement
Time frame: 30min
As for FHR
MHR bland altman
Time frame: 30min
As for FHR
MHR deming regression
Time frame: 30min
As for FHR
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 9 Feb 2021.
- Derived from this study: PubMed 34666382Gonzalez 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.
- Individual participant dataSharing planned: No
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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.
Megahan G Hill, MBBS principal investigator
Banner- University of Arizona Medical Center
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 GE Healthcare at 1 site in United States.
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 9 Feb 2021. 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 United States. 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 Percent Agreement (time frame: 30min). The study lists 8 primary outcomes in all. 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 NCT03057275, which also lists 1 linked publication.
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 9 Feb 2021.