Novel uterine contraction monitoring to enable remote, self-administered nonstress testing

Schwartz, Nadav; Mhajna, Muhammad; Moody, Heather L.; Zahar, Yael; Shkolnik, Ketty; Reches, Amit; Lowery, Curtis L.

doi:10.1016/j.ajog.2021.11.018

Cited by 10 publications

(10 citation statements)

References 45 publications

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“…It should be noted that due to the small sample size, clear conclusions cannot be drawn here, yet a trend is noticeable. These results replicated our previous finding ( Schwartz et al, 2022 ), showing a significant reduction in TOCO’s positive agreement for obese group compared to normal weight group, whereas the positive agreement of INVU did not vary across different BMI groups.…”

Section: Discussionsupporting

confidence: 91%

“…As described above, it is possible that some of these surplus contractions detected by INVU may be derived from myometrial activation leading to the generation of an isobaric contraction that does not alter the intrauterine pressure, but still results in a structural change that can alter the propagation of electrical and acoustic signals through the tissue. Such a contraction can still be detected by INVU’s abdominal sensors; however, as these mechanical changes do not induce pressure changes, this activity would not be detected by IUPC or by TOCO and could therefore be reported as a false positive ( Schwartz et al, 2022 ). A similar phenomenon is also relevant to explain the reported FDR in EHG-based devices (up to 21.4% ( Vlemminx et al, 2017 ; Hadar et al, 2015 ; Cohen and Hayes-Gill, 2014 )), which are triggered by the myometrial electrical signal, even if no significant muscle contraction ensues ( Jacod et al, 2010 ).…”

Section: Discussionmentioning

confidence: 99%

“…The measurements used in this work were taken from two separate prospective, comparative, open-label, multi-center studies ( Mhajna et al, 2020 ) ( Schwartz et al, 2022 ). The studies were conducted in accordance with the principles set forth in the Declaration of Helsinki and in compliance with ICH-GCP standards.…”

Section: Methodsmentioning

confidence: 99%

“…Moreover, the compromise of reducing the quality of the aforementioned FHR and MHR recordings due to the conflicting nature of optimal sensor positions for UA and FMHR monitoring ( Rooijakkers et al, 2014 ) is avoided with the INVU by using a single sensor system for both measurements. The clinical performance of non-invasively detecting UA with INVU while conducting remote NSTs has been recently described and validated ( Schwartz et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

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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: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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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“…Seminal studies established feasibility and utility of each technology independently and set the stage for a paradigm shift towards remote maternal-fetal assessment. [14][15][16][17][18][19][20] However, the combination of the fetal nonstress test heart monitoring and US amniotic fluid evaluation scored by the modified biophysical profile (mBPP) achieve a better detection rate for fetal acidemia than either of the technologies apart. [21][22][23][24][25][26] In most centers, maternal-fetal surveillance requires that the patients physically arrive at the unit and spend up to several hours waiting between tests.…”

Section: Introductionmentioning

confidence: 99%

Integrating technologies to provide comprehensive remote fetal surveillance: A prospective pilot study

Nir,

Dvir,

Galler

et al. 2023

Intl J Gynecology & Obste

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ObjectiveTo determine the feasibility of extending remote maternal‐fetal care to include fetus well‐being.MethodsThe authors performed a prospective pilot study investigating low‐risk pregnant participants who were recruited at the time of their first full‐term in‐person visit and scheduled for a follow‐up telemedicine visit. Using novel self‐operated fetal monitoring and ultrasound devices, fetal heart monitoring and amniotic fluid volume measurements were obtained to complete a modified biophysical profile (mBPP). Total visit length was measured for both the in‐person first visit and the subsequent telemedicine encounter. A patient satisfaction survey form was obtained.ResultsTen women between 40 + 1 and 40 + 6 weeks of gestation participated in telemedicine encounters. Nine women (90%) were able to complete remote mBPP assessment. For one participant, fetal assessment was not completed due to technically inconclusive fetal monitoring. Another participant was referred for additional assessment in the delivery room. Satisfactory amniotic fluid volume measurements were achieved in 100% of participants. The telemedicine encounter was significantly shorter (93.1 ± 33.1 min) than the in‐person visit (247.2 ± 104.7 min; P < 0.001). We observed high patient satisfaction.ConclusionRemote fetal well‐being assessment is feasible and time‐saving and results in high patient satisfaction. This novel paradigm of comprehensive remote maternal and fetal assessment is associated with important clinical, socioeconomic, and logistics advantages.

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Telemedicine and Digital Health Solutions in Intrapartum and Postpartum Care

Stone,

Hirshberg

2024

Curr Obstet Gynecol Rep

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Purpose of Review Telemedicine and digital health platforms are now integral to the way patients and clinicians interact with the health system. Application of these technologies in the antepartum context is well studied and accepted. The purpose of this review is to outline the state of telemedicine and digital health solutions in the intrapartum and postpartum period, understanding applications for labor and the months following delivery. Recent Findings Telemedicine can be used in the intrapartum period to assist with staffing shortages, remote assessment of intrapartum fetal heart tracings, and doula support. Application in the postpartum period includes but is not limited to remote blood pressure monitoring, lactation support, mental health screening and treatment, and substance use disorder. Summary Both telemedicine and digital health solutions aim to augment, not replace, care relationship during pregnancy, delivery, and postpartum. Whether these tools advance intrapartum and postpartum care remains subject to the same contingencies present in other specialties and care contexts. Ongoing investment into the application and evaluation of telemedicine and digital health solutions throughout pregnancy should be prioritized.

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Novel uterine contraction monitoring to enable remote, self-administered nonstress testing

Cited by 10 publications

References 45 publications

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

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

Integrating technologies to provide comprehensive remote fetal surveillance: A prospective pilot study

Telemedicine and Digital Health Solutions in Intrapartum and Postpartum Care

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