Cited by 89Non-Invasive Vital Sign MonitoringECG Monitoring and AnalysisHeart Rate Variability and Autonomic Control

Wireless, remote solution for home fetal and maternal heart rate monitoring

Open access
Mhajna, Muhammad, Schwartz, Nadav, Levit-Rosen, Lorinne, Warsof, Steven, Lipschuetz, Michal, Jakobs, Martin, Rychik, Jack, Sohn, Christof +1 more·2020·American Journal of Obstetrics & Gynecology MFM

Abstract

BACKGROUND: Access to prenatal care can be challenging due to physician shortages and rural geography. The multiple prenatal visits performed to collect basic fetal measurements lead to significant patient burden as well. The standard of care tools for fetal monitoring, external fetal heart rate monitoring with cardiotocography, as used today, must be applied by a medical professional in a healthcare setting. Novel tools to enable a remote and self-administered fetal monitoring solution would significantly alleviate some of the current barriers to care. OBJECTIVE: To compare maternal and fetal heart rate monitoring data obtained by 'Invu system' (a wireless, wearable, self-administered, fixed-location device containing passive electrical and acoustic sensors) to cardiotocography, toward a true remote fetal monitoring solution. MATERIALS AND METHODS: A prospective, open-label, multicenter study evaluated concurrent use of Invu and cardiotocography in pregnant women, aged 18 to 50 years, with singleton pregnancies ≥32+0 weeks' gestation (NCT03504189). Simultaneous recording sessions from Invu and cardiotocography lasted for ≥30 minutes. Data from the 8 electrical sensors and 4 acoustic sensors in the Invu belt were acquired, digitized, and sent wirelessly for analysis by an algorithm on cloud-based servers. The algorithm validates the data, preprocesses the data to remove noise, detects heartbeats independently from the two data sources (electrical and acoustic), and fuses the detected heartbeat arrays to calculate fetal heart rate (FHR) and maternal heart rate (MHR). The primary performance endpoint was Invu FHR limit of agreement within ± 10 beats per minute (bpm) of FHR measured with cardiotocography. RESULTS: A total of 147 women were included in the study analysis. The mean (SD) maternal age was 31.8 ±6.9 years, and the mean gestational age was 37.7 ±2.3 weeks. There was a highly significant correlation between FHR measurements from Invu and cardiotocography (r = 0.92; P<0.0001). The 95% limits of agreement for the difference, the range within which most differences between the two measurements will lie, were -8.84 bpm to 8.24 bpm. Invu measurements of MHR were also very similar to cardiotocography and were highly significantly correlated (r = 0.97; P<0.0001). No adverse events were reported during the study. CONCLUSION: Although captured by very different methods, the FHR and MHR outputs wirelessly obtained by the Invu system through passive methods were very similar to those obtained by the current standard of care. The limits of agreement for FHR measured by Invu were within a clinically acceptable ± 8 bpm of cardiotocography FHR. The Invu device uses passive technology to allow for safe, non-invasive and convenient monitoring of patients in the clinic and remotely. Further work should investigate how remote perinatal monitoring could best address some of the recent challenges seen with prenatal care and maternal and fetal outcomes. CLINICAL TRIAL INFORMATION: Registration date: April 20, 2018; First participant enrollment: February 28, 2018; ClinicalTrials.gov registration NCT03504189; https://clinicaltrials.gov/ct2/show/NCT03504189.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1016/j.ajogmf.2020.100101

Cites

29 of 29 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 2

  1. Reed SF, Ohel G, David R, Porges SW. A neural explanation of fetal heart rate patterns: a test of the polyvagal theory. Dev Psychobiol 1999;35:108-18.
  2. Clifford GD, Silva I, Behar J, Moody GB. Noninvasive fetal ECG analysis. Physiol Meas 2014;35:1521-36.

Cited by

Sorted by citations

Authors
Mhajna, M., Schwartz, N., Levit-Rosen, L., Warsof, S., Lipschuetz, M., Jakobs, M., Rychik, J., Sohn, C., & Yagel, S.
Affiliations
  • University of Pennsylvania (US)
  • Hadassah Medical Center (IL)
  • Eastern Virginia Medical School (US)
  • University Hospital Heidelberg (DE)
  • Children's Hospital of Philadelphia (US)
Corresponding author
Mhajna, Muhammad
Venue
American Journal of Obstetrics & Gynecology MFM
Publisher
Elsevier BV
Published
2020-05
Volume
2
Issue
2
Pages
100101
ISSN
2589-9333 (ISSN-L)
OpenAlex
W3012162245
Cited by
88
References
29
Citations by year
2026: 11 · 2025: 16 · 2024: 15 · 2023: 21 · 2022: 15 · 2021: 9 · 2020: 1
FWCI
3.61
Type
journal article
Language
en
Open access
Locations
  • American Journal of Obstetrics & Gynecology MFM (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
Keywords
cardiotocography, wearable sensors, wireless monitoring, fetal heart rate, maternal heart rate, heartbeat detection, sensor fusion, prenatal care access, limits of agreement, cloud-based data analysis, rural healthcare access, patient burden, singleton pregnancy, gestational age 32 weeks
MeSH terms
Adult, Female, Fetal Monitoring, Heart Rate, Fetal, Humans, Infant, Pregnancy, Prenatal Care, Prospective Studies, Cardiotocography, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review