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

Last updated: February 16, 2026
Sponsor: Nestmedic Spolka Akcyjna
Overall Status: Completed

Phase

N/A

Condition

Labor/delivery

Pregnancy

Treatment

PregnaOne System

Clinical Study ID

NCT07223996
004
  • Ages > 22
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to independently read and understand written and spoken English and willing toprovide written informed consent and comply with all instructions required by thestudy protocol.

  • Female aged 22 years or older.

  • Estimated gestational age between 32 and 41 weeks.

  • Singleton gestation.

  • Pre-pregnancy or first prenatal visit BMI < 40 kg/m².

  • Able and willing to undergo fetal monitoring sessions in a simulated homeenvironment at the study site.

  • Women who do not meet the gestational age criterion at the screening visit but willmeet it by the study visit (within two weeks) may be enrolled.

Exclusion

Exclusion Criteria:

  • In active labor or in the delivery room during labor.

  • Requires hospitalization or life support.

  • Any contraindications for cardiotocography (CTG) monitoring.

  • Severe hypertension (≥160/110 mmHg measured twice, 15 minutes apart).

  • Known allergy to latex, ultrasound (US) gel, or ECG gel.

  • Skin conditions (e.g., edema, erythema, irritation, infection, lesions, or openwounds) at contact points for the Pregnabit Pro or comparator devices.

  • Implanted electronic devices (e.g., pacemaker, stimulator, defibrillator, pump).

  • Members of vulnerable populations other than pregnant women (e.g., minors, wards ofthe state, cognitively impaired individuals, prisoners, or institutionalizedpersons).

Study Design

Total Participants: 71
Treatment Group(s): 1
Primary Treatment: PregnaOne System
Phase:
Study Start date:
October 01, 2025
Estimated Completion Date:
January 30, 2026

Study Description

This is a prospective, single-visit, non-randomized, comparative study designed to evaluate the PregnaOne System, an investigational Class II medical device intended for in-home fetal monitoring. The system includes the Pregnabit Pro device and associated software that collect and transmit data on fetal heart rate, fetal movement, maternal pulse rate, and uterine muscle activity for remote review by healthcare professionals.

The goal of this study is to assess the safety, usability, and signal performance of the PregnaOne System compared to the INVU system, an FDA-cleared home fetal monitoring device. The study will be conducted under a non-significant risk (NSR) designation.

Approximately 70 pregnant women in their third trimester will be enrolled at three U.S. medical centers. Each participant will attend one in-clinic visit simulating an at-home environment. The study visit includes:

Training session - participants are instructed on how to use the PregnaOne System.

First monitoring session - a 30-minute fetal monitoring period using both the PregnaOne System and the INVU system simultaneously.

Second monitoring session - a 30-minute self-conducted monitoring session using only the PregnaOne System without staff assistance.

During each session, participants remain in a seated or reclined position and record fetal movements. Study staff will be available to assist and ensure participant safety.

No known risks are associated with fetal heart rate monitoring, though mild discomfort from device straps may occur.

Participants receive compensation for their time and travel. Study data will support the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA).

Connect with a study center

  • Christie Clinic, LLC

    Champaign 4887158, Illinois 4896861 61820
    United States

    Site Not Available

  • The Iowa Clinic, P.C.

    West Des Moines 4881346, Iowa 4862182 50266
    United States

    Site Not Available

  • Wilmington Health, PLLC

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Site Not Available

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