Biophysical profile by self-operated clinician-guided ultrasound versus standard ultrasound: An observational study

To evaluate the feasibility and accuracy of remote, clinician-guided biophysical profile (BPP) assessment using a handheld ultrasound device operated by lay users.

This prospective, non-randomized, quasi-blinded study compared clinician-guided ultrasound-based BPP scans performed remotely by lay users using the Pulsenmore ES device with concomitant standard in-clinic ultrasound examinations performed by healthcare professionals, with both assessments conducted consecutively and immediately one after the other. Agreement between modalities was assessed for individual BPP components and overall BPP scores.

A total of 30 pregnant women were enrolled at a mean gestational age of 33.0 ± 2.6 weeks. The mean maternal age was 31.4 ± 4.5 years, and mean body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) was 27.4 ± 5.2. Overall agreement between remote and in-clinic BPP scores was 90%. Agreement was 100% for cardiac activity, fetal movements, fetal presentation, placental location, and subjective amniotic fluid volume assessment. Agreement for fetal tone and breathing movements was 96.7 and 93.3%, respectively. Sensitivity and specificity of remote BPP assessment for detecting abnormal overall BPP findings, using the standard in-clinical ultrasound examination as the reference standard, were 92.6 and 66.7%. The mean difference in total BPP score was 0.07 ± 0.64 points. Mean fetal heart rate and maximal vertical pocket measurements were comparable between modalities. Remote examinations required more time than in-clinic scans (8.0 ± 3.9 vs. 4.6 ± 3.3 min) but remained within recommended limits.

Clinician-guided remote BPP assessment using a handheld ultrasound device operated by lay users demonstrates high agreement with standard in-clinic ultrasound under supervised conditions and may represent a reliable alternative for prenatal surveillance in selected populations.