Evaluating the Safety of PregSense™ and Compare Its Performance to CTG in Prenatal Monitoring of Pregnant Subjects

Nuvo-Group

Status: Completed

Conditions: Pregnancy

Treatments: Device: PregSense™; Device: Cardiotocopraphy (CTG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03504189

CLP1000

Details and patient eligibility

About

This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.

Full description

PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.

Enrollment: 151 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female age between 18-50
• Gestational age > 32 + 0 weeks
• Singleton gestation
• Ability to understand and sign informed consent

Exclusion criteria

• BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
• Multiple gestation
• Uncontrolled Hypertension
• Fetal Anomaly
• Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
• Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
• Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

PregSense™

Experimental group

Description:

PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring

Treatment:

Device: PregSense™

Device: Cardiotocopraphy (CTG)