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)

General Electric (GE)

Status: Completed

Conditions: Term Labour

Treatments: Device: Monica Novii Wireless Patch System

Study type: Observational

Funder types: Industry

Identifiers

NCT03409146

1404298207

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

Term Patients

Description:

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

Treatment:

Device: Monica Novii Wireless Patch System