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)

NCT03409146 | Completed FDA Device

• 1 other identifier: 1404298207
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Term Labour

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Mean Percentage FHR Equivalence

  through study completion, an average of 1 year

• Uterine Activity (UA) Sensitivity (from Individual Contractions)

  through study completion, an average of 1 year

• Uterine activity Positive Percentage Agreement (from Interpretable Data)

  through study completion, an average of 1 year

• Maternal Heart Rate (MHR) Positive Percentage Agreement (PPA)

  through study completion, an average of 1 year

• Mean Percentage MHR Equivalence

  through study completion, an average of 1 year

Study Arms (1)

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

Device: Monica Novii Wireless Patch System

Interventions

Monica Novii Wireless Patch System DEVICE

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.

Term Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women at term
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women at Term

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Study Design

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

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 24, 2018
• Study Start: May 28, 2014
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)