Skip to content
English
Contact us
  • There are no suggestions because the search field is empty.

Validation that INVU is Comparable to SoC for fHR

The following summary provides a high-level overview of a peer-reviewed study describing a wireless, remote, self-administered solution for fetal and maternal heart rate monitoring.

Background:

Access to prenatal care can be limited due to physician shortages and geographic barriers, particularly in rural areas. The need for repeated in-clinic visits to collect basic fetal measurements places a significant burden on patients. Current standard-of-care fetal monitoring, based on external cardiotocography, must be performed by trained medical professionals in a healthcare setting. These limitations highlight the need for remote, self-administered fetal monitoring solutions that can reduce barriers to care.

Objective:

The objective of this study was to compare fetal heart rate (FHR) and maternal heart rate (MHR) measurements obtained using the Invu system, a wireless, wearable, self-administered device to those obtained using cardiotocography, with the goal of enabling a true remote fetal monitoring solution.

Results:

1. Participants: 147 women; mean maternal age 31.8 years; mean gestational age 37.7 weeks.

2. Fetal heart rate:

2.1. Strong correlation between Invu and cardiotocography measurements (r = 0.92, P<0.0001).

2.2. 95% limits of agreement ranged from –8.84 bpm to 8.24 bpm.

3. Maternal heart rate:

Very strong correlation between Invu and cardiotocography (r = 0.97, P<0.0001).

4. Safety:

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.
 
The full article is available at:
 
https://www.ajogmfm.org/article/S2589-9333(20)30031-8/fulltext
 

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

  • American Journal of Obstetrics & Gynecology 2020