An observational study in Term Labour, sponsored by GE Healthcare. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by GE Healthcare · Observational
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
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.
Pregnant Women at Term
A woman will be considered for inclusion in the study if she fulfills all of the following criteria:
Exclusion Criteria:
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
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.
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.
Time frame: through study completion, an average of 1 year
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".
Time frame: 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
Time frame: 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".
Time frame: 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.
Time frame: 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".
Time frame: through study completion, an average of 1 year
Plan to share: No
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