Status:
RECRUITING
Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study
Lead Sponsor:
Nestmedic Spolka Akcyjna
Conditions:
Pregnancy
Fetal Monitoring
Eligibility:
FEMALE
22+ years
Phase:
NA
Brief 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 tri...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Able to independently read and understand written and spoken English and willing to provide written informed consent and comply with all instructions required by the study 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 home environment at the study site.
- Women who do not meet the gestational age criterion at the screening visit but will meet it by the study visit (within two weeks) may be enrolled.
Exclusion
- 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 open wounds) 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 of the state, cognitively impaired individuals, prisoners, or institutionalized persons).
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07223996
Start Date
October 1 2025
End Date
June 30 2026
Last Update
November 3 2025
Active Locations (3)
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1
Christie Clinic, LLC
Champaign, Illinois, United States, 61820
2
The Iowa Clinic, P.C.
West Des Moines, Iowa, United States, 50266
3
Wilmington Health, PLLC
Wilmington, North Carolina, United States, 28401