Clinical trial 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)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Term Labour
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2018-01-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Women at Term

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fetal Heart Rate (FHR) Positive Percentage Agreement (PPA)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Mean Percentage FHR Equivalence
timeFrame: through study completion, an average of 1 year
measure: Uterine Activity (UA) Sensitivity (from Individual Contractions)
timeFrame: through study completion, an average of 1 year
measure: Uterine activity Positive Percentage Agreement (from Interpretable Data)
timeFrame: through study completion, an average of 1 year
measure: Maternal Heart Rate (MHR) Positive Percentage Agreement (PPA)
timeFrame: through study completion, an average of 1 year
measure: Mean Percentage MHR Equivalence
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
References: