A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device
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 m...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-07-01
|
| Series: | Frontiers in Bioengineering and Biotechnology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fbioe.2022.933612/full |
| _version_ | 1811295400965963776 |
|---|---|
| author | Muhammad Mhajna Boaz Sadeh Simcha Yagel Christof Sohn Nadav Schwartz Steven Warsof Yael Zahar Amit Reches |
| author_facet | Muhammad Mhajna Boaz Sadeh Simcha Yagel Christof Sohn Nadav Schwartz Steven Warsof Yael Zahar Amit Reches |
| author_sort | Muhammad Mhajna |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T05:32:56Z |
| format | Article |
| id | doaj.art-37e00ea0059d4dcfb9b7602a004bec04 |
| institution | Directory Open Access Journal |
| issn | 2296-4185 |
| language | English |
| last_indexed | 2024-04-13T05:32:56Z |
| publishDate | 2022-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Bioengineering and Biotechnology |
| spelling | doaj.art-37e00ea0059d4dcfb9b7602a004bec042022-12-22T03:00:23ZengFrontiers Media S.A.Frontiers in Bioengineering and Biotechnology2296-41852022-07-011010.3389/fbioe.2022.933612933612A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote DeviceMuhammad Mhajna0Boaz Sadeh1Simcha Yagel2Christof Sohn3Nadav Schwartz4Steven Warsof5Yael Zahar6Amit Reches7Nuvo-Group, Ltd, Tel-Aviv, IsraelNuvo-Group, Ltd, Tel-Aviv, IsraelDepartment of Obstetrics and Gynecology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, IsraelDepartment of Obstetrics and Gynecology, University Hospital, Heidelberg, GermanyMaternal and Child Health Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United StatesOb-Gyn/MFM at Eastern Virginia Medical School, Norfolk, VA, United StatesNuvo-Group, Ltd, Tel-Aviv, IsraelNuvo-Group, Ltd, Tel-Aviv, IsraelBackground: 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.https://www.frontiersin.org/articles/10.3389/fbioe.2022.933612/fullbiomedical signal processingelectrocardiography (ECG)Gynecology & Obstetricsphonocardiography (PCG)telemedicinewearable device |
| spellingShingle | Muhammad Mhajna Boaz Sadeh Simcha Yagel Christof Sohn Nadav Schwartz Steven Warsof Yael Zahar Amit Reches A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device Frontiers in Bioengineering and Biotechnology biomedical signal processing electrocardiography (ECG) Gynecology & Obstetrics phonocardiography (PCG) telemedicine wearable device |
| title | A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device |
| title_full | A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device |
| title_fullStr | A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device |
| title_full_unstemmed | A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device |
| title_short | A Novel, Cardiac-Derived Algorithm for Uterine Activity Monitoring in a Wearable Remote Device |
| title_sort | novel cardiac derived algorithm for uterine activity monitoring in a wearable remote device |
| topic | biomedical signal processing electrocardiography (ECG) Gynecology & Obstetrics phonocardiography (PCG) telemedicine wearable device |
| url | https://www.frontiersin.org/articles/10.3389/fbioe.2022.933612/full |
| work_keys_str_mv | AT muhammadmhajna anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT boazsadeh anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT simchayagel anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT christofsohn anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT nadavschwartz anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT stevenwarsof anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT yaelzahar anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT amitreches anovelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT muhammadmhajna novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT boazsadeh novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT simchayagel novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT christofsohn novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT nadavschwartz novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT stevenwarsof novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT yaelzahar novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice AT amitreches novelcardiacderivedalgorithmforuterineactivitymonitoringinawearableremotedevice |