Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study

This study evaluates the safety and performance of the PregnaOne System, a non-significant risk (NSR) investigational medical device for in-home fetal monitoring in pregnant women during the third trimester. The PregnaOne System consists of the Pregnabit Pro device and related software, designed to record fetal heart rate, maternal pulse, and uterine contractions in a home-like environment. The study compares the performance of the PregnaOne System with a similar FDA-cleared at-home monitoring system (the INVU system by Nuvo). Approximately 70 pregnant women will participate at three medical centers in the United States. Each participant will complete one training session and two fetal monitoring sessions during a single study visit.

NCT Number	NCT07223996
Lead Sponsor	Nestmedic Spolka Akcyjna
Conditions	Pregnancy, Fetal Monitoring
Enrollment	71 participants
Start Date	2025-09-30
Primary Completion	2026-01-30 (estimated)
Study Completion	2026-01-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-20