401 Amplitude-modulation of maternal electrocardiography and phonocardiography as a novel method for wireless non-invasive uterine monitoring

Mhajna, Muhammad; Reches, Amit; Zahar, Yael; Schwartz, Nadav

doi:10.1016/j.ajog.2020.12.422

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“…INVU correctly identified 500 contractions of the 557 reference (IUPC) contractions detected by an automatic marking algorithm, yielding a sensitivity of 89.8%, while the sensitivity of TOCO was 38.5%. Results from blinded, human assessors reviewing the same dataset ( Mhajna et al, 2021 ) comparing INVU to IUPC are also promising, showing a similar sensitivity of 87.7%. A high sensitivity of 94% was also observed for INVU in the antepartum study, with TOCO as reference.…”

Section: Discussionmentioning

confidence: 92%

A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device

Mhajna

Sadeh²,

Sohn³

et al. 2022

Front. Bioeng. Biotechnol.

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Background: Uterine activity (UA) monitoring is an essential element of pregnancy management. The gold-standard intrauterine pressure catheter (IUPC) is invasive and requires ruptured membranes, while the standard-of-care, external tocodynamometry (TOCO)’s accuracy is hampered by obesity, maternal movements, and belt positioning. There is an urgent need to develop telehealth tools enabling patients to remotely access care. Here, we describe and demonstrate a novel algorithm enabling remote, non-invasive detection and monitoring of UA by analyzing the modulation of the maternal electrocardiographic and phonocardiographic signals. The algorithm was designed and implemented as part of a wireless, FDA-cleared device designed for remote pregnancy monitoring. Two separate prospective, comparative, open-label, multi-center studies were conducted to test this algorithm.Methods: In the intrapartum study, 41 laboring women were simultaneously monitored with IUPC and the remote pregnancy monitoring device. Ten patients were also monitored with TOCO. In the antepartum study, 147 pregnant women were simultaneously monitored with TOCO and the remote pregnancy monitoring device.Results: In the intrapartum study, the remote pregnancy monitoring device and TOCO had sensitivities of 89.8 and 38.5%, respectively, and false discovery rates (FDRs) of 8.6 and 1.9%, respectively. In the antepartum study, a direct comparison of the remote pregnancy monitoring device to TOCO yielded a sensitivity of 94% and FDR of 31.1%. This high FDR is likely related to the low sensitivity of TOCO.Conclusion: UA monitoring via the new algorithm embedded in the remote pregnancy monitoring device is accurate and reliable and more precise than TOCO standard of care. Together with the previously reported remote fetal heart rate monitoring capabilities, this novel method for UA detection expands the remote pregnancy monitoring device’s capabilities to include surveillance, such as non-stress tests, greatly benefiting women and providers seeking telehealth solutions for pregnancy care.

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Section: Discussionmentioning

confidence: 92%