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Completed

NCT Number: NCT03409146

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)

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

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Key information

Conditions

Term Labour

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Percentage FHR Equivalence

    Time frame: through study completion, an average of 1 year

    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".

  2. Uterine Activity (UA) Sensitivity (from Individual Contractions)

    Time frame: through study completion, an average of 1 year

    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

  3. Uterine activity Positive Percentage Agreement (from Interpretable Data)

    Time frame: through study completion, an average of 1 year

    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".

  4. Maternal Heart Rate (MHR) 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 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.

  5. Mean Percentage MHR Equivalence

    Time frame: through study completion, an average of 1 year

    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".

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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