Term Labour
Conditions
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
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.
Interventions
DEVICEMonica 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.
Sponsors
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Rate (FHR) Positive Percentage Agreement (PPA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage FHR Equivalence | 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. |
| Uterine Activity (UA) Sensitivity (from Individual Contractions) | 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 |
| Uterine activity Positive Percentage Agreement (from Interpretable Data) | 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. |
| Maternal Heart Rate (MHR) Positive Percentage Agreement (PPA) | 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. |
| Mean Percentage MHR Equivalence | 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. |
Countries
United States
Outcome results
None listed