This prospective observational study evaluated the feasibility and accuracy of remote, clinician-guided biophysical profile (BPP) assessment using the Pulsenmore ES handheld ultrasound device operated by lay users, compared consecutively with standard in-clinic ultrasound by healthcare professionals in 30 pregnant women at a mean gestational age of 33.0 ± 2.6 weeks.
Overall BPP score agreement between remote and in-clinic modalities was 90%, with 100% agreement for cardiac activity, fetal movements, fetal presentation, placental location, and amniotic fluid volume; sensitivity for detecting abnormal BPP was 92.6% but specificity was only 66.7%. Remote scans took longer (8.0 ± 3.9 vs. 4.6 ± 3.3 min) but stayed within recommended limits.
Very small sample size (n=30) limits generalizability; quasi-blinded design and supervised in-clinic setting may not reflect real-world home use; low specificity (66.7%) for abnormal BPP detection raises concern for false positives.
Clinician-guided remote BPP using a lay-operated handheld device shows promising agreement with standard ultrasound, but the low specificity and small sample size mean it is not yet ready to replace in-clinic surveillance — it may be a useful adjunct for selected low-risk or remote-access populations pending larger validation studies.
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