Term LabourNCT03409146
Accuracy and Reliability of Novii: Fetal Heart Rate (FHR), Maternal Heart Rate (MHR) and Uterine Contraction (UA) Compared With Doppler, Scalp Fetal Scalp Electrode (FSE), Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC)
An observational study of Term Labour, run by GE Healthcare at 1 site in United States.
Trial summary
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Term Labour
- What is being tested?
- Monica Novii Wireless Patch System
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2014to 13 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant Women at Term
Who may be able to join
- A woman will be considered for inclusion in the study if she fulfills all of the following criteria:
- She has a term or near term (≥36 completed weeks) singleton gestation in a cephalic presentation and has been admitted to the Labor and Delivery Unit .
- She is in the latent phase of spontaneous labor, or has been admitted for induction of labor.
- She has given her informed consent to participate as a subject.
- She has none of the exclusion criteria.
Who cannot join
- Known major fetal malformation or chromosome abnormality.
- Multiple gestation
- A condition for which cesarean will likely be carried out shortly.
- Subject plans not to have electronic fetal monitoring.
- 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. Medical Center employees, prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Medical Center
Tucson, Arizona, 85724
About this study
Official title: Accuracy and Reliability of a New Intrapartum Fetal Heart Rate, Maternal Heart Rate, and Uterine Contraction Monitoring Method Compared With Food and Drug Administration (FDA) Approved Techniques.
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
Read the detailed description
The study is being done to test the performance of a Novii Wireless Patch System for following the baby's and mother's heart rates and uterine contractions during labor. We want to find out if the new monitor works as well as other types of monitors that are usually used: Doppler Fetal Heart Rate (FHR), Scalp FHR, Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC).
80 patients will be monitored during the study.
- Conditions
- Term Labour
- Being tested
- Monica Novii Wireless Patch System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monica Novii Wireless Patch SystemDevice
The Monica Novii Wireless Patch System is a transabdominal fetal/maternal recorder that provides fetal heart rate, maternal heart rate and maternal uterine activity contractions.
| Study group | Role | What they receive |
|---|---|---|
| Term Patients | Approximately 80 pregnant women monitored in labor between 37 and 42 weeks' gestation will be necessary to complete the study. Subjects will have a singleton >37 week pregnancy.
Subjects will be recruited for the study in the following groups :
At least 10 patients with Body Mass Index (BMI) < 30 kg/m2 At least 10 patients with BMI 30-34.9 kg/m2 At least 10 patients with BMI ≥ 35 kg/m2 Receives: Device: Monica Novii Wireless Patch System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal Heart Rate (FHR) Positive Percentage Agreement (PPA)
PPA(%)=(a/(a+C))x100, where "a" represents the number of 2 second epochs when the Novii FHR is within +/-10% of the predicate device FHR for each 2 second epoch, and "c" are the number of 2 second epochs when the Novii FHR is not within +/- 10% of the predicate device FHR or is absent.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Mean Percentage FHR Equivalence
The 2 second output FHR data when both the predicate and Novii devices are reporting a value will be considered. In this case for each 2 second epoch the FHR value from the Novii device is divided by the predicate device FHR value to create a "FHR ratio".
Measured: through study completion, an average of 1 year
Uterine Activity (UA) Sensitivity (from Individual Contractions)
The Sensitivity of the Novii System against the predicate device is determined from the "individual contraction "detection as follows: Sensitivity(%)=(x/(x+z))x100
Where:
"x" is the total number of "individual contractions" detected by both the devices "z" is the total number of "individual contractions" detected by the predicate device only
Measured: through study completion, an average of 1 year
Uterine activity Positive Percentage Agreement (from Interpretable Data)
The positive percentage agreement (PPA) is determined from the interpretable and uninterpretable data as follows:
PPA(%)=(a/(a+c))x100
Where:
"a" is the number of minutes when both devices UA are "interpretable" at the same time "c" is the number of minutes when the predicate device UA is "interpretable" but the Novii system UA is "un-interpretable".
Measured: through study completion, an average of 1 year
Maternal Heart Rate (MHR) Positive Percentage Agreement (PPA)
PPA(%)=(a/(a+C))x100, where "a" represents the number of 2 second epochs when the Novii MHR is within +/-10% of the predicate device MHR for each 2 second epoch, and "c" are the number of 2 second epochs when the Novii MHR is not within +/- 10% of the predicate device MHR or is absent.
Measured: through study completion, an average of 1 year
Mean Percentage MHR Equivalence
The 2 second output MHR data when both the predicate and Novii devices are reporting a value will be considered. In this case for each 2 second epoch the MHR value from the Novii device is divided by the predicate device MHR value to create a "MHR ratio".
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start28 May 2014
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Term LabourStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409146
- Sponsor's protocol ID
- 1404298207
- Status last verified
- Feb 2021
- First submitted
- 11 Jan 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Accuracy and Reliability of a New Intrapartum Fetal Heart Rate, Maternal Heart Rate, and Uterine Contraction Monitoring Method Compared With Food and Drug Administration (FDA) Approved Techniques.
- ClinicalTrials.gov ID
- NCT03409146
- Acronym / sponsor ID
- 1404298207
- Conditions
- Term Labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 28 May 2014 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 24 Jan 2018 (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.
Accuracy and Reliability of the Novii device (fetal heart rate, maternal heart rate and uterine activity) compared with Food and Drug Administration (FDA) approved techniques
Detailed description
The study is being done to test the performance of a Novii Wireless Patch System for following the baby's and mother's heart rates and uterine contractions during labor. We want to find out if the new monitor works as well as other types of monitors that are usually used: Doppler Fetal Heart Rate (FHR), Scalp FHR, Tocodynamometer (TOCO) and Intra Uterine Pressure Catheter (IUPC).
80 patients will be monitored during the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term Patients | – | Device: Monica Novii Wireless Patch SystemApproximately 80 pregnant women monitored in labor between 37 and 42 weeks' gestation will be necessary to complete the study. Subjects will have a singleton >37 week pregnancy. Subjects will be recruited for the study in the following groups : At least 10 patients with Body Mass Index (BMI) < 30 kg/m2 At least 10 patients with BMI 30-34.9 kg/m2 At least 10 patients with BMI ≥ 35 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant Women at Term
Key inclusion criteria (5 listed)
- A woman will be considered for inclusion in the study if she fulfills all of the following criteria:
- She has a term or near term (≥36 completed weeks) singleton gestation in a cephalic presentation and has been admitted to the Labor and Delivery Unit .
- She is in the latent phase of spontaneous labor, or has been admitted for induction of labor.
- She has given her informed consent to participate as a subject.
- She has none of the exclusion criteria.
Key exclusion criteria (10 listed)
- Known major fetal malformation or chromosome abnormality.
- Multiple gestation
- A condition for which cesarean will likely be carried out shortly.
- Subject plans not to have electronic fetal monitoring.
- 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 |
|---|---|---|
| Monica Novii Wireless Patch SystemThe Monica Novii Wireless Patch System is a transabdominal fetal/maternal recorder that provides fetal heart rate, maternal heart rate and maternal uterine activity contractions. | Device | Term Patients |
Primary outcome
Fetal Heart Rate (FHR) Positive Percentage Agreement (PPA)
Time frame: through study completion, an average of 1 year
PPA(%)=(a/(a+C))x100, where "a" represents the number of 2 second epochs when the Novii FHR is within +/-10% of the predicate device FHR for each 2 second epoch, and "c" are the number of 2 second epochs when the Novii FHR is not within +/- 10% of the predicate device FHR or is absent.
5 secondary outcomes
Mean Percentage FHR Equivalence
Time frame: through study completion, an average of 1 year
Uterine Activity (UA) Sensitivity (from Individual Contractions)
Time frame: through study completion, an average of 1 year
Uterine activity Positive Percentage Agreement (from Interpretable Data)
Time frame: through study completion, an average of 1 year
Maternal Heart Rate (MHR) Positive Percentage Agreement (PPA)
Time frame: through study completion, an average of 1 year
Mean Percentage MHR Equivalence
Time frame: through study completion, an average of 1 year
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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Term Labour, 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 5 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?
Fetal Heart Rate (FHR) Positive Percentage Agreement (PPA) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.