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Three Missing Pieces To Improving Maternal Mortality in the U.S.

Solving pregnancy care challenges involves addressing the areas of Interest, Investment, and Innovation.

Sometimes problems are relative, sometimes they are absolute. In the United States, maternal mortality is both. As of April 2022, the U.S. ranked last among other high income nations for maternal mortality rates. In absolute terms, the U.S. maternal mortality rates trend up, year after year. Most notably, maternal mortality among black women is staggeringly high. In fact, black women are three times more likely to die from pregnancy related causes than their white counterparts in the U.S. These sobering stats are true despite the fact that the U.S. spends more than any other nation on in-hospital maternity care. Despite significant publicity, women continue to die needlessly in their quest to bring new life into the world. This must change.

Sadly, these trends are old news. From 1955 until 1985 maternal mortality in the United States decreased by 99 percent. This enormous public health victory halted after 1985. Since 1985 U.S. maternal mortality rates have trended steeply up. There is no consensus on why the U.S. fares so poorly compared to other developed nations - and even lags behind some underdeveloped countries. However, there is consensus around one thing - it is time to fix these trends and save women’s lives.

Albert Einstein said that if he had an hour to solve a problem he would spend 55 minutes thinking about the problem and five minutes thinking about the solution. There is no question that we are thinking about this problem. High-profile news outlets are publicizing this crisis. This year alone, CNN, ABC, and the Wall Street Journal all published prominent articles about maternal mortality and lack of care in the United States. These articles represent noble efforts to galvanize support to halt and reverse these painful trends. Our federal government has introduced no less than 26 bills to address maternal mortality. State governments have introduced even more than that. Celebrities like Serena Williams, Beyonce, Michelle Obama, and Kamala Harris have all been shouting from the mountaintops about the black maternal mortality crisis. Major entities like Optum, Merck, and the Wilson Center all dedicate enormous resources to publicizing and understanding the maternal mortality problem.

No doubt, publicity, funding, and legislation like this is good. But the harsh reality is that elevating the profile of maternal mortality is only good if it induces action. We are heeding Albert Einstein’s advice - sort of - by spending time and resources on the problem. Einstein’s quote implies, however, that those 55 minutes should be dedicated to really digging into the roots of the problem, why it exists, and how it came to be. That we have not done.

Unless and until we move from awareness to action, we will not reverse these harrowing trends. We owe it to women to value their lives and the lives of their babies enough to find a new way of thinking about maternal mortality.

To solve this problem we need to focus on three things:

  • Interest
  • Investment
  • Innovation

Interest

Given the publicity mentioned earlier, calling for more interest may seem counterintuitive. Yet, even with all of the publicity and attention, the U.S. population generally, and the medical/public health community specifically, does not focus on maternal mortality in the United States. Other than Merck, there are no Fortune 500 companies that devote their charitable dollars towards maternal mortality improvements. Sure, giants like Walmart, Target, Medtronic, Genentech, State Farm, Best Buy, and Accenture have teamed up to create the Black Community Innovation Coalition. But maternal/fetal health is only a small subset of this effort. While black maternal mortality is an outsized problem compared to maternal mortality for other demographics, focusing exclusively on the problem for black women does not address the problem for everyone. In short, most of Corporate America is not yet focused on fixing this problem.

There is also a dearth of interest from the public generally. As former Congressman and Obstetrician, Phil Gingrey, points out, “more must be done; more coordination, more dedication, and more dollars.” This issue cannot be solved until Americans across the map recognize the problem and demand change from their representatives, corporations, and doctors.

Investment

Interest is necessary but not sufficient. Maternal health needs investment. In 2016, pregnancy and postpartum care cost private insurers $52.8 billion - making it the third highest cost condition in the United States. However, conditions like diabetes and back/neck pain impact far more people than pregnancy at any given moment in time. Much of that $52.8 billion dollars could be saved with more investment into new innovations and technologies for prenatal care.

Investment trends for FemTech are, admittedly, good. VC funding for FemTech between 2015-2021 went from $600 million to $1.9 billion. Even with this increase, FemTech and maternal care is still sorely underfunded. Just 2% of medtech funding goes towards non-cancer related women’s conditions. The trends are in maternal care’s favor. We have reason to be hopeful. But there is still a large gap between the need in the market and the funding to scale solutions. We urgently need passionate and brave investors to see the massive opportunity that exists to modernize pregnancy care and get in on the ground floor of new maternal health technology that opens access, utilizes telemedicine, and changes standards of care.

Innovation

Finally, we must see innovation in this space. Obstetric ultrasound was created in 1956. In the 1970’s OB ultrasound exploded as the standard of care. But the 1970’s were the beginning and the end of significant technological innovation in maternal care. In the last 50 years, image quality has improved but there has been virtually no significant technological change for maternal care. Doctors still use 40 year old technology to measure and examine pregnant mothers and their fetuses. But there is hope and we are on the cusp of a revolution.

Technologies like Nuvo’s remote maternal-fetal monitoring, PulseNmore’s remote OB ultrasound, and Ouma Health’s telemedicine network will change not just how women are treated, but also who can access excellent care. Until these, and other innovations are created, approved, and adopted at scale, we cannot change the status quo of maternal morbidity and mortality in the U.S. Once real changes in interest, investment, and innovation happen, more mothers will get to see their beautiful babies grow and thrive. The time has come to make this a reality.

This article was published in collaboration with Andrea Wolf on LinkedIn.

Nuvo Group and Sheba Medical Center's "Sheba BEYOND" Complete First Phase of Collaboration to Create a Virtual Obstetric Solution & Catalyze Research to Advance the Standard of Pregnancy Care

Nuvo Group and Sheba Medical Center's "Sheba BEYOND" Complete First Phase of Collaboration to Create a Virtual Obstetric Solution & Catalyze Research to Advance the Standard of Pregnancy Care

Early-stage collaboration includes the evaluation of a new virtual care regimen for managing gestational diabetes and the use of AI to develop personalized care pathways and predictive analytics

TEL AVIV, Israel, Aug. 17, 2022 /PRNewswire/ -- Nuvo Group—the creators of INVU by Nuvo™, an FDA-approved remote pregnancy monitoring platform—announced today that it has completed the first phase of its collaboration agreement with Israel's Sheba Medical Center's "Sheba BEYOND", one of the Top Ten medical centers in the world (NEWSWEEK) and a global leader in biotechnological innovation.

The first phase of the partnership consisted of a groundbreaking pilot program around gestational diabetes management, in which medically necessary non-stress tests (NSTs) were shifted to home-based, remote monitoring using INVU™ rather than conducting traditional monitoring in a medical facility. Participating physicians prescribed INVU to expectant mothers, who wore the sensor band from home during virtual visits. During these virtual visits anchored by the hospital's Sheba BEYOND, virtual hospital platform, a live reading allowed the expectant mother to access simplified data and insights via the paired INVU app, while the provider received more detailed fetal and maternal surveillance that OB/GYNs are accustomed to receiving during in-office visits.

To provide a comprehensive virtualized care regimen, the pilot program also included the use of several other telemedicine solutions alongside INVU, including a remote ultrasound device, glucose monitoring, and home urinalysis kit. In addition to offering a safe and proven regimen for managing gestational diabetes, the program aimed to help patients and providers save time and ultimately improve the overall care experience.

For the next phase of the partnership, Nuvo and Sheba intend to work together to integrate the INVU platform into the hospital's standard of care protocols. They also plan to utilize data collected from the pilot program to develop new AI tools with the goals of advancing pregnancy care management, improving outcomes, and lowering costs.

"Our long term goal is to provide pregnant women with the best possible maternal-fetal surveillance wherever they are – in our clinics, at the comfort of their home or during their work day," said Dr. Avi Tsur, high-risk pregnancy expert and director of Sheba's Women's Health Innovation Center and Sheba BEYOND's Obstetrics & Gynecology Beyond tele-health platform. "The INVU fetal monitoring solution has the potential to be a catalyst of transformative care in an area of medicine that has been lagging in innovation and new approaches for decades. I hope this pilot is only the beginning."

Dr. Galia Barkai, Director of Sheba BEYOND added, "Sheba Beyond is constantly adopting cutting-edge technologies, which are enabling patients to receive the best care in the comfort of their homes. This collaboration is yet another step towards our goal to bring high level, hospital care, to everyone, everywhere."  

"It is an honor to collaborate with a leading medical center like Sheba to bring Nuvo's INVU technology to expectant mothers in Israel," said Kelly Londy, CEO of Nuvo Group. "The INVU platform is particularly beneficial for high-risk pregnancies that would otherwise require frequent in-office visits, which we know can become burdensome on all sides. We look forward to the next phase of our partnership as we continue to work with Sheba to help deliver safe and reliable remote care to even more patients."

"Sheba aspires to be the institution that comes to mind when thinking about transformative healthcare," Prof. Eyal Zimlichman, chief transformation officer and chief innovation officer at Sheba Medical Center maintained. "We do this by staying ahead of the curve when it comes to the latest and greatest advancements, as we know that transformation via innovation is the fastest path to material change. We're excited about what this partnership with Nuvo can mean for the future of pregnancy care."

About Nuvo Group

Based in Tel Aviv, Israel, Nuvo Group Ltd. ("Nuvo") is committed to reinventing pregnancy care for the 21st century through new technology, tools, and practices for providers and expectant mothers, including the INVU by Nuvo™ platform, an FDA-cleared, prescription initiated remote pregnancy monitoring and management system. The INVU™ sensor band enables the delivery of remote non-stress tests and maternal & fetal heart rate monitoring today while pioneering new data-driven personalized pathways that Nuvo believes will help improve health outcomes for all women in the future. The technology and patent estate that underpin the INVU platform have been awarded a number of industry recognitions, including Fast Company's Next Big Things in Tech (2021), CB Insights' Digital Health 150 (2020), and MedTech Innovator's Top 50 MedTech Startups (2021), as well as multiple grants from some of the world's leading academic medical centers and scientific bodies. Nuvo is led by a diverse team of experienced business and medical professionals, dedicated data engineers, software designers and proud parents who embrace a collective mission to give every life a better beginning.

For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com.

About Sheba Medical Center

The largest and most comprehensive medical center in the Middle East, Sheba Medical Center, Tel Hashomer is generating global impact through its medical care, research and healthcare transformation. Sheba's City of Health boasts an acute-care hospital, rehabilitation hospital, research and innovation hubs, medical simulation center, as well as a center for disaster response on one comprehensive campus in the heart of Israel. Sheba BEYOND is the medical center's innovative virtual hospital, which offers a myriad of technological solutions for advanced patient care. For more information, visit: eng.sheba.co.il

SOURCE Nuvo Group

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

Technical publication detailing Nuvo's innovative technology platform and algorithms for monitoring fetal heart rate, maternal heart rate and uterine contraction activity.

This article was originally published in Frontiers in Bioengineering & Biotechnology July 2022 here.

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.

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

AJOG 2022 article validating Nuvo's ability to monitoring uterine contraction activity remotely. "This novel method to noninvasively monitor uterine activity, via a wireless pregnancy monitoring device designed for self-administration at home, was more accurate than the commonly used tocodynamometry and unaffected by body mass index. Together with the previously reported remote fetal heart rate monitoring capabilities, this added ability to detect uterine contractions has created a complete telehealth solution for remote administration of nonstress tests."

This article was originally published in AJOG in 2022 here.

Background

The serial fetal monitoring recommended for women with high-risk pregnancies places a substantial burden on the patient, often disproportionately affecting underprivileged and rural populations. A telehealth solution that can empower pregnant women to obtain recommended fetal surveillance from the comfort of their own home has the potential to promote health equity and improve outcomes. We have previously validated a novel, wireless pregnancy monitor that can remotely capture fetal and maternal heart rates. However, such a device must also detect uterine contractions if it is to be used to robustly conduct remote nonstress tests.

Objective

This study aimed to describe and validate a novel algorithm that uses biopotential and acoustic signals to noninvasively detect uterine contractions via a wireless pregnancy monitor.

Study Design

A prospective, open-label, 2-center study evaluated simultaneous detection of uterine contractions by the wireless pregnancy monitor and an intrauterine pressure catheter in women carrying singleton pregnancies at ≥32 0/7 weeks’ gestation who were in the first stage of labor (ClinicalTrials.gov Identifier: NCT03889405). The study consisted of a training phase and a validation phase. Simultaneous recordings from each device were passively acquired for 30 to 60 minutes. In a subset of the monitoring sessions in the validation phase, tocodynamometry was also deployed. Three maternal-fetal medicine specialists, blinded to the data source, identified and marked contractions in all modalities. The positive agreement and false-positive rates of both the wireless monitor and tocodynamometry were calculated and compared with that of the intrauterine pressure catheter.

Results

A total of 118 participants were included, 40 in the training phase and 78 in the validation phase (of which 39 of 78 participants were monitored simultaneously by all 3 devices) at a mean gestational age of 38.6 weeks. In the training phase, the positive agreement for the wireless monitor was 88.4% (1440 of 1692 contractions), with a false-positive rate of 15.3% (260/1700). In the validation phase, using the refined and finalized algorithm, the positive agreement for the wireless pregnancy monitor was 84.8% (2722/3210), with a false-positive rate of 24.8% (897/3619). For the subgroup who were monitored only with the wireless monitor and intrauterine pressure catheter, the positive agreement was 89.0% (1191/1338), with a similar false-positive rate of 25.4% (406/1597). For the subgroup monitored by all 3 devices, the positive agreement for the wireless monitor was significantly better than for tocodynamometry (P<.0001), whereas the false-positive rate was significantly higher (P<.0001). Unlike tocodynamometry, whose positive agreement was significantly reduced in the group with obesity compared with the group with normal weight (P=.024), the positive agreement of the wireless monitor did not vary across the body mass index groups.

Conclusion

This novel method to noninvasively monitor uterine activity, via a wireless pregnancy monitoring device designed for self-administration at home, was more accurate than the commonly used tocodynamometry and unaffected by body mass index. Together with the previously reported remote fetal heart rate monitoring capabilities, this added ability to detect uterine contractions has created a complete telehealth solution for remote administration of nonstress tests.

Philips teams up with Nuvo to broaden maternity care access in rural areas with remote monitoring tech

Health tech player Philips is joining forces with Nuvo Group to increase access and adherence to prescribed maternity care in rural areas, the companies announced Tuesday.

This article originally appeared in Fierce Healthcare here.

Health tech player Philips is joining forces with Nuvo Group to increase access and adherence to prescribed maternity care in rural areas, the companies announced Tuesday.

More than half (54%) of U.S. counties have limited or no access to maternity care and about 35% of those counties are considered maternity care deserts, according to March of Dimes. That leaves more than two million women of reproductive age living in areas with no hospital offering obstetric care, no obstetric provider and no birth center.

In collaborating with Philips, Nuvo will leverage its INVU solution, an FDA-approved remote fetal monitoring platform that facilitates remote non-stress tests and maternal and fetal heart rate monitoring.

The companies will pilot the joint program in rural Colorado as part of an integrated solution for providers. Philips will provide support for the program’s delivery, according to the company.

“Digital solutions and ecosystem-building are critical enablers to addressing disparities in healthcare such as access to maternal healthcare in rural settings,” said Sandra Lesenfants, general manager of hospital patient monitoring at Philips, in a statement. “With this collaboration, we are extending the sight and reach of pregnancy care and bringing more remote monitoring options to the communities and expectant mothers where and when they need them most.”

Nuvo’s remote monitoring solution also has the potential to reduce provider burden by shifting care to the home, the company said, by allowing providers to prescribe the INVU sensor band to expectant mothers to wear during virtual visits.

The band transmits live non-stress test readings comparable to in-office fetal surveillance to the provider while allowing the mother to view her data and insights in the paired app.

“Collaborating with Philips is an important step in our efforts to bring more comprehensive pregnancy care solutions to patients, providers and payers,” said Kelly Londy, Nuvo CEO, in a statement. “Philips has long been a leader in providing high-quality care in the obstetrics space, and we feel that this deep history, coupled with INVU’s unique ability to meet moms where they are, will be game-changing for the industry.”

Maternal mortality rates in the U.S., some of the highest in the developed world, are particularly elevated among Black and Native American women.

The White House released a fact sheet in December urging the healthcare industry to work to improve health outcomes for mothers and infants.

In November, more than 200 hospitals signed on to join the Department of Health and Human Services’ new maternal and infant health initiative to address these disparities by capturing data to improve care practices.

Philips previously invested in Babyscripts, a virtual care platform that uses tech and remote monitoring to deliver prenatal and postpartum care and enhance risk detection.

The health tech company participated in the startup’s $12 million series B round in September.

Q&A with Ryan Kraudel of Nuvo: Eliminating barriers to pregnancy care

Q&A with Ryan Kraudel of Nuvo discussing how clinicians, patients, and payers are seeing value from remote pregnancy monitoring.

AVIA Connect is the leading online resource for accurate, unbiased information about digital health companies and solutions. Our goal: To empower hospitals and health systems with the information they need to match with vendors who can meet their individual needs. We asked the top remote monitoring companies about their solutions and what they think the future of digital health looks like. No sponsored content or advertorials—just transparency and insights that decision-makers can use.

Nuvo takes aim at outdated models of pregnancy care with its INVU remote prenatal care platform, which allows pregnant patients to conduct asynchronous prenatal visits and fetal non-stress tests from home. The INVU sensor band, which is FDA-cleared for use during pregnancy at 32 weeks and beyond, securely sends physiological data to obstetric providers with accuracy comparable to in-office readings. Providers can review data through the clinician dashboard, while a parent-facing app provides personalized pregnancy insights to patients.

Ryan Kraudel, Nuvo’s Vice President of Marketing, leads global marketing for Nuvo and is responsible for all areas of marketing strategy and execution. He has over 20 years of experience achieving revenue and valuation targets in growth stage organizations. His previous career highlights include leading the marketing team for one of the market’s leading innovators in biometric sensors used in millions of consumer wearables.

Q: Can you tell us about your company and the challenges you are solving within the remote monitoring space?

A: Nuvo’s mission is to give every life a better beginning. Nuvo was founded to address the very intimate challenges that parents face throughout the various stages of pregnancy. We believe that both clinicians and parents would benefit from more and better real-time data to improve pregnancy outcomes and reduce worry and stress. INVU provides a remote pregnancy monitoring platform so that physicians can monitor and consult mothers as needed in the comfort of their own environments, no matter where they are.

Q: How does your company differentiate from other remote monitoring vendors?

A: Our FDA-cleared remote pregnancy monitoring and management platform offers clinical grade fetal monitoring that is self-administered in the safety and convenience of one’s home as part of a connected care regime with an OB team. We shift the point-of-care to the expectant mom, which facilitates access to high-quality remote care.

From a clinical perspective, existing standard methods for data collection have some notable limitations. The tocodynamometer (TOCO), which is the current standard of care, requires patients to travel to the clinic to be plugged into a machine that offers shallow and unreliable data. The gold standard of care, the intrauterine pressure catheter (IUPC), also requires the patient to travel to a clinic to be plugged into an invasive piece of equipment.

We have a novel method of capturing uterine activity which performs extremely well against the IUPC and is less invasive. We believe that INVU is the first FDA-cleared, prescription-initiated remote pregnancy monitoring and management platform that allows providers to conduct remote fetal non-stress tests.

In addition to our remote monitoring technology, we are developing an AI-powered big data platform that will enable personalized predictive care pathways and allow us to improve outcomes for all women.

Q: What are some of the biggest changes your company has seen around how health systems are approaching remote monitoring since 2020?

A: 2020 was an inflection point for everyone around the globe, particularly as it relates to healthcare. Clinicians, hospital systems and patients were forced to leverage online activity in every aspect of people’s lives, so patients and hospitals have seen the significant value that remote monitoring and healthcare can deliver. The demand for virtual pregnancy care solutions accelerated during the pandemic and continues to rise because time-pressed millennial moms want to be digitally empowered. We commissioned a survey in partnership with Wakefield Research that shows that 77 percent of new and expectant mothers would prefer to do some of their prenatal visits remotely (as long as their doctor could provide the same level of care). In the past two years, it's become evident the high cost of in-clinic care is unsustainable, while remote monitoring has shown not only clinical efficacy, but also improvements in quality of life for patients and providers.

Q: What does an ideal client look like? How are health systems best organized for success in remote monitoring?

A: An ideal client for Nuvo is a large healthcare organization, self-insured employer or payer that is responsible for a large number of pregnancies. There are a number of pressing needs and challenges that can be addressed by Nuvo, including geographic barriers to care (maternity deserts), health inequities/financial limitations and a shortage of OB-GYNs. Nuvo has seen great traction with organizations that are dealing with these challenges. We are also seeing the virtual care movement continue to shift to specialty care, with an increased demand stemming from the pandemic and desire among busy moms for telehealth options and easier access to care.

Q: What measurable outcomes have you seen from your clients who have prioritized remote monitoring?

A: Nuvo is democratizing access to the highest standard of pregnancy care by addressing the most common barriers to care:

  • Concerns about potential exposure to illnesses like COVID-19, cold/flu and others
  • Geographic barriers–over 50 percent of U.S. counties lack an OB-GYN
  • Financial limitations
  • Competing priorities, like jobs and other children, that make it difficult to find time for in-office visits

The demand for virtual pregnancy care solutions accelerated during the pandemic and only continues to rise.

Q: What major functional enhancements and/or product investments are you making in the near term to keep up with the evolution of remote monitoring?

A: We’re building on the INVU platform to accelerate innovation in pregnancy care. These investments are focused on three primary areas: pregnancy care decision support systems, population health tools, and novel AI models that generate unique insights into pregnancy care delivery.

Q: How is your company partnering with clients as reimbursements and use cases shift?

A: Nuvo has established collaborations with several clinical and technology leaders in the healthcare sector, including Axia Women’s Health, Unified Women’s Healthcare, University of Pennsylvania Medicine, University of Utah, Philips and Babyscripts. We work closely with our partners to ensure our collaborations are driving value in a highly dynamic healthcare environment.

Q: What are the biggest opportunities health systems should be thinking about this year when it comes to remote monitoring?

A: Health systems should be thinking about utilizing remote monitoring in pregnancy care. There are troubling trends in U.S. pregnancy care involving outcomes, access to care and costs:

  • Outcomes: The U.S. ranks 52nd in global infant mortality rates, according to the World Factbook 2020
  • Access to care: 50 percent of US counties do not have a practicing obstetrician, a rate that is expected to increase with fewer new OB-GYNs each year
  • Cost: Pregnancy care is one of only four health conditions that drive over $100 billion in annual healthcare spending, while adoption of remote monitoring in pregnancy care has lagged compared to remote monitoring for other health conditions.

Remote monitoring has shown the potential to have a positive impact on each of these trends. Health systems that get ahead of this curve put themselves in a strong competitive position.

Q: How do you see remote monitoring evolving in 2022 and beyond?

A: Remote monitoring will continue to grow as clinicians get more comfortable with the technology and see the value it can provide, and as patients increasingly expect healthcare services to meet them where they are. In addition, remote monitoring will begin to unlock new insights into individual and population health by enabling analysis of real world patient data at scale.

Wireless remote solution for home fetal and maternal heart rate monitoring

2020 AJOG publication validating Nuvo's maternal and fetal heart rate capabilities.

This article was originally published in AJOG in 2020 here.

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.


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