Status:
COMPLETED
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)
Lead Sponsor:
GE Healthcare
Conditions:
Term Labour
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 28 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 13 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03409146
Start Date
May 28 2014
End Date
February 13 2017
Last Update
February 9 2021
Active Locations (1)
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1
University of Arizona Medical Center
Tucson, Arizona, United States, 85724