Fetal Heart Rate and Amniotic Fluid Volume Measurements with a Home Ultrasound Device

Area of Science:

• Medical Devices
• Obstetrics and Gynecology
• Telemedicine

Background:

• Remote fetal assessment is crucial for antenatal surveillance, particularly in underserved areas.
• Existing methods often require in-person visits, posing logistical challenges.
• The Pulsenmore ES system offers a novel self-scanning ultrasound solution for remote fetal evaluation.

Purpose of the Study:

• To evaluate the usability and accuracy of the Pulsenmore ES system for remote fetal heart rate (FHR) and maximal vertical pocket (MVP) measurements.
• To compare measurements obtained via the self-scanning system with standard in-clinic ultrasound assessments.
• To assess the feasibility of layperson operation for remote fetal monitoring.

Main Methods:

• A prospective, non-randomized, non-blinded clinical study involving 28 women.
• Scans were performed by laypersons in either app-guided (AG) or clinician-guided (CG) modes.
• Measurements were compared to immediate, in-clinic (INC) ultrasound scans.

Main Results:

• High successful utilization rates for FHR (84.7% AG, 96.3% CG) and MVP (91.7% AG, 95.0% CG) measurements.
• Accurate FHR measurements with low differences from INC values (10.8 bpm AG, 5.8 bpm CG).
• Accurate MVP measurements with low differences from INC values (1.3 cm AG, 0.9 cm CG), demonstrating good sensitivity and specificity.

Conclusions:

• The Pulsenmore ES self-scanning ultrasound platform provides accurate and reliable FHR and MVP measurements for clinical use.
• Home-based ultrasound assessments using this system can significantly contribute to remote antenatal surveillance.
• The system demonstrates high usability and accuracy, supporting its role in modern obstetric care.