RSS-Feed abonnieren

DOI: 10.1055/a-2469-0887
Fetal Heart Rate and Amniotic Fluid Volume Measurements with a Home Ultrasound Device
Funding This work was supported by a research grant from Pulsenmore (number 0062-23-RMC). The funding source had no role in the design of this study.

Abstract
Objective
Pulsenmore ES is a self-scanning ultrasound (US) system for remote fetal assessment. It comprises a handheld transducer that serves as a smartphone cradle coupled with an application and clinician's web-viewer dashboard. Recently, a novel capability was added to the system allowing offline fetal heart rate (FHR) and maximal vertical pocket (MVP) measurements. The aim of this study was to evaluate these tools for usability and accuracy.
Study Design
A prospective, non-randomized, non-blinded clinical study design was used. Pulsenmore ES scans were obtained by non-professional laypersons in app-guided (AG) mode (user follows video tutorials in the application) or clinician-guided (CG) mode (user is guided by a health care professional in a real-time telemedicine visit). The scans were stored on a cloud for later interpretation by a health care professional. Each self-scan was immediately followed by a standard US scan performed by a clinician. The asynchronous FHR and MVP measurements made on the AG and CG scans through the designated dashboard were analyzed and compared with the real-time, in-clinic (INC) measurements.
Results
The cohort included 28 women. Rates of successful utilization of the Pulsenmore tool for measurement of FHR were 84.7 ± 11.24% of scans made in AG mode and 96.3 ± 6.35% of scans made in CG mode. Corresponding values for MVP were 91.7 ± 2.31% and 95.0 ± 1.73%. FHR accuracy (difference from INC values) was 10.8 ± 7.5 beats per minute (bpm; 7.2%) in AG mode and 5.8 ± 5.1 bpm (4%) in CG mode. MVP accuracy was 1.3 ± 1.4 cm (22%) and 0.9 ± 0.8 cm (14%), respectively. Sensitivity (87.5% and 100% in AG and CG modes, respectively) and specificity (95% and 95.5% in AG and CG modes, respectively) were established for MVP.
Conclusion
FHR and MVP measurements obtained from scans captured by the self-operated Pulsenmore ES ultrasound platform are highly accurate and reliable for clinical use relative to standard INC measurements.
Key Points
-
Pulsenmore ES is a self-scanning US system for remote fetal assessment.
-
FHR and MVP can be accurately and remotely measured from home.
-
Home US can play a critical role in remote antenatal surveillance.
Keywords
ultrasound - home - mobile - fetal heart rate - amniotic fluid volume - maximal vertical pocketPublikationsverlauf
Eingereicht: 07. September 2024
Angenommen: 14. November 2024
Accepted Manuscript online:
19. November 2024
Artikel online veröffentlicht:
31. Dezember 2024
© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA
-
References
- 1
American College of Obstetricians and Gynecologists.
Implementing Telehealth in Practice: ACOG Committee Opinion Summary, Number 798. Obstet
Gynecol 2020; 135 (02) 493-494
MissingFormLabel
- 2
Hadar E,
Wolff L,
Tenenbaum-Gavish K.
et al.
Mobile self-operated home ultrasound system for remote fetal assessment during pregnancy.
Telemed J E Health 2022; 28 (01) 93-101
MissingFormLabel
- 3
Nir O,
Dvir G,
Galler E.
et al.
Integrating technologies to provide comprehensive remote fetal surveillance: a prospective
pilot study. Int J Gynaecol Obstet 2024; 164 (02) 662-667
MissingFormLabel
- 4
Pontones CA,
Titzmann A,
Huebner H.
et al.
Feasibility and acceptance of self-guided mobile ultrasound among pregnant women in
routine prenatal care. J Clin Med 2023; 12 (13) 4224
MissingFormLabel
- 5
Axelrod M,
Lahav Ezra M,
Galler E.
et al.
Putting the “f”etus back in maternal-fetal telemedicine: a prospective pilot study.
Am J Obstet Gynecol 2024; 228 (1 Suppl): S544
MissingFormLabel
- 6
Weiner E,
Cartun Z,
Kleiner I,
Michal L,
Marom O,
Tamayev L.
Virtual prenatal care: the effect of telemedicine and home-ultrasound on maternal
anxiety and attachment during pregnancy in women with a history of pregnancy loss.
Obstet Gynecol 2023; 141 (5S): 81S
MissingFormLabel
- 7
Hadar E,
Pardo A,
Barbash-Hazan S.
et al.
Self-operated home ultrasound and remote experts' review: real-life data results.
Ultrasound Obstet Gynecol 2022; 60 (Suppl. 01) 13S
MissingFormLabel
- 8
Van Leeuwen P,
Cysarz D,
Edelhäuser F,
Grönemeyer D.
Heart rate variability in the individual fetus. Auton Neurosci 2013; 178 (1-2): 24-28
MissingFormLabel
- 9
Sande JA,
Ioannou C,
Sarris I,
Ohuma EO,
Papageorghiou AT.
Reproducibility of measuring amniotic fluid index and single deepest vertical pool
throughout gestation. Prenat Diagn 2015; 35 (05) 434-439
MissingFormLabel
- 10
Nakai A,
Oya A.
Accuracy and reproducibility of ultrasound measurements in obstetric management. Gynecol
Obstet Invest 2002; 54 (01) 31-36
MissingFormLabel
- 11
Peedicayil A,
Mathai M,
Regi A,
Aseelan L,
Rekha K,
Jasper P.
Inter- and intra-observer variation in the amniotic fluid index. Obstet Gynecol 1994;
84 (05) 848-851
MissingFormLabel
- 12
Magann EF,
Whittington JR,
Morrison JC,
Chauhan SP.
Amniotic fluid volume assessment: eight lessons learned. Int J Womens Health 2021;
13: 773-779
MissingFormLabel
- 13
Toscano M,
Marini T,
Lennon C.
et al.
Diagnosis of pregnancy complications using blind ultrasound sweeps performed by individuals
without prior formal ultrasound training. Obstet Gynecol 2023; 141 (05) 937-948
MissingFormLabel
- 14
Hallak M,
Kirshon B,
O'Brian Smith E,
Evans MI,
Cotton DB.
Subjective ultrasonographic assessment of amniotic fluid depth: comparison with the
amniotic fluid index. Fetal Diagn Ther 1993; 8 (04) 256-260
MissingFormLabel
- 15
Williams K,
Wittmann BK,
Dansereau J.
Correlation of subjective assessment of amniotic fluid with amniotic fluid index.
Eur J Obstet Gynecol Reprod Biol 1992; 46 (01) 1-5
MissingFormLabel
- 16
Hughes DS,
Magann EF.
Antenatal fetal surveillance “Assessment of the AFV”. Best Pract Res Clin Obstet Gynaecol
2017; 38: 12-23
MissingFormLabel