Workshop on Technology to Improve Maternal Health

Executive Summary

Disclaimer

This material should not be interpreted as representing the viewpoint of the U.S. Department of Health and Human Services, the National Institutes of Health, or the National Institute of Biomedical Imaging and Bioengineering. Names of companies and organizations are listed for information purposes only. Inclusion in this document is not an endorsement or promotion for any products or services. Refer to website disclaimers.

Overview

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) along with 10 partner NIH Institutes[1] and the Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health (ORWH) conducted a half day workshop on January 18, 2022 to assess the state of the art in technology to improve maternal heath, identify technology gaps, and consider how new technologies can be used to improve maternal health and ultimately treat and/or prevent maternal morbidity and mortality (MMM). This workshop brought together panelists from small businesses, technology developers, academic researchers, and community partners to further advance interdisciplinary collaborations in maternal health and technology. The panelists had wide ranging expertise in areas such as bioengineering, venture capital, community health and preventative medicine, health disparities, digital health platforms, along with nurse and physician scientists in cardiovascular, sepsis, psychiatry, and obstetrics and gynecology specialties.

Background

In 2020, the maternal mortality rate for non-Hispanic Black women was 55.3 deaths per 100,000 live births, 2.9 times the rate for non-Hispanic White women.[2] Rates of MMM in the United States continue to rise, with Black, Indigenous, and other people of color facing significantly higher risks than a white birthing person. African American/Black and American Indian/Alaska Natives are two to four times more likely to die from pregnancy related causes compared to whites.

The seven leading causal factors implicated in U.S. maternal mortality include thrombotic pulmonary embolism, hemorrhage, hypertensive disorders of pregnancy, infection, cardiomyopathy, cardiovascular conditions, and non-cardiovascular medical conditions[3]. This workshop supported NIH’s initiatives to bring awareness and solutions to these health concerns by bridging together different communities (small business, clinical researchers, and community partners) to envision how technology development can be used to improve maternal health.

The overall goals of the workshop were:

1. To further advance interdisciplinary collaborations in maternal health technology by bringing together an interdisciplinary community of partners to identify technology gaps and consider how new technologies can be used to improve maternal health and ultimately treat and/or prevent MMM.
2. To reduce MMM among high-risk populations, by considering social determinants of health (SDoH) to  understand the needs of the communities serving birthing people.
3. Finally, to provide awareness of the technology market in maternal health to enable the development and commercialization of low-cost, accessible, technology-based strategies for MMM.

The key meeting objectives were:

• Describe societal implications and determinants of inadequate maternal care
• Review the state of technology in maternal health and identify gaps and translational challenges
• Identify maternal health, clinical, and community care innovations or areas ready for translation
• Understand community needs that can be addressed by development, commercialization, and sustainable implementation of technologies
• Develop strategies to connect small businesses and collaborate with the community.

Summary

Keynote Speaker

The keynote speaker, Dr. Elizabeth Howell from the University of Pennsylvania, gave an overview of “The Maternal Health Crisis: How Did We Get Here and How Can Technology Help Us?” Dr. Howell framed the problem in the United States by showing statistics that the U.S. is ranked 10 out of 10 (worst possible) in maternal mortality when compared with other wealthy countries. In the U.S., racial/ethnic, geographic, and educational disparities exist to compound this problem. Additionally, the underlying causes of pregnancy-related deaths differ by race/ethnicity. Dr. Howell explained that more than 60% of maternal deaths are preventable. She then outlined levers to improve maternal health by: eliminating bias, enhancing communication, and engaging the community. Dr. Howell spoke about how technology tools can address maternal health across the care continuum from pre-conception to postpartum. Technology such as care coordination, telehealth, data analytics, connected home monitoring and wearable trackers can be used; however, there are several challenges to the use of technology in this area. Most notably, interventions that don’t focus on equity, usability, and user preferences can inadvertently widen racial and socioeconomic disparities. Dr. Howell ended her presentation highlighting several different types of technology that researchers at the University of Pennsylvania are currently working on in the maternal technology field. These include an at-home blood pressure monitor, a text message-based antenatal education and blood pressure monitoring program, a fourth-trimester care smart phone app that provides parents with around the clock access to clinical guidance, a community care model that provides an extra layer of support for a pregnant person, and a remote fetal monitor for high-risk pregnancies.

Panel 1: Technology

Key points discussed during this panel:

• Sensors and monitoring devices have not previously been tested on large cohorts of women or pregnant persons, which is vital to establish normal baselines.
• Several different types of technology can be used to address MMM:  improved diagnostic devices, wearable sensors, and digital healthcare delivery platforms are a few examples.
• Funding for this type of technology has traditionally been difficult to obtain, however, there are new venture capital firms dedicated to “femtech” (or female technology) which includes technology to improve maternal health.

The panelists in this session discussed current technology that is being developed for femtech or can be adapted to address maternal health concerns. These technologies included a point-of-care test to screen for preeclampsia and other conditions using a single finger-prick drop of blood. Several different types of wearable monitors from “Band-Aid” style monitors for heart rate, respiratory rate, and other vital signs, to noninvasive digital fabric biosensors integrated into bras have been developed. Additionally, several digital maternal health care delivery platforms were discussed that provide education, patient monitoring, and access to appropriate health care providers. Some of these technologies were able to be integrated with wearable sensors and predictive models. Panelists also discussed challenges in developing technology for maternal health such as the exclusion of women, pregnant persons, and minoritized populations from many datasets used in technology development and the need to generate these datasets so that gender and racial differences are not overlooked. Finally, the difficulty of obtaining funding for the development of these technologies for women and maternal health was mentioned. Currently, there is hope on the horizon as specialized venture firms that invest only in women’s health now exist. The presenters reminded the small business community that this is not a niche market as women are 50% of the population and that birthing people birth 100% of the population.

Panel 2: Clinical Outcomes

Key points discussed during this panel:

• There are numerous diseases that affect maternal health, many more than could be discussed.
• Pregnancy related diseases and conditions can occur at any time during the maternal health care continuum (preconception, antepartum, delivery, or postpartum) and may present differently than for patients not on the maternal health care continuum.
• Early screening for prevention and treatment for common chronic diseases such as cardiovascular and metabolic disorders and mental health disorders can help to mitigate long term complications; however, more research is needed on these diseases during the maternal health care continuum.
• Panelists in this session focused on diabetes, preeclampsia, peripartum cardiomyopathy, sepsis, perinatal mood and anxiety disorders, and substance use disorders in pregnancy.
• New technologies can help to assess risk, screen for, diagnose, treat, monitor, and follow-up on conditions and diseases that affect maternal health.

Panelists in this session were leaders in clinical research addressing specific pregnancy-related diseases and conditions and discussed the implications for maternal health. Researchers in diabetes noted that for all types of diabetes there are stringent glycemic targets to reduce adverse outcomes and long-term complications for both the pregnant person and the fetus. Technologies in continuous glucose monitoring can help to hit targets and improve outcomes. Participants noted that studies of insulin pump use during pregnancy have resulted in conflicting findings. There is a need for new studies with automated technologies to assess glucose control during pregnancy. Researchers stated that new NIH-supported studies are forthcoming. Researchers in preeclampsia noted that it is a common condition that severely affects maternal health. Advanced screening to predict the disease using known biomarkers and artificial intelligence (AI) and machine learning combined with a drug to treat or prevent this condition would be a breakthrough for maternal health. Phenotyping the disease could also be an important step, as clinical assessments of preeclampsia can be unreliable. Researchers in peripartum cardiomyopathy (PPCM) note that this disease occurs in one in 2,000 live births in the U.S. and is more common among Black women. Genetic background affects risk and may predict outcomes and recovery. However, there are still many unanswered questions relating to PPCM, especially during pregnancy. Improved screening, better prediction of clinical outcomes, and use of new diagnostics possibly with the help of AI or machine learning are all areas which need further research. Researchers in sepsis noted that it is the second leading cause of pregnancy-related mortality in the U.S. Many maternal deaths from sepsis are preventable but were not averted due to delays in seeking care, diagnosis, treatment, and escalation of care. Diagnosis is a challenge as many physiological changes associated with pregnancy are similar to those associated with sepsis. Since most cases occur in patients without risk factors, it is important to screen all patients. Technology for postpartum surveillance and monitoring could be effective, as a third of maternal deaths and 50% of cases occur postpartum. However, such technology should incorporate pregnancy adjustments, assess all vital signs, and initiate alert systems when sepsis is suspected. Participants also discussed perinatal mood and anxiety disorders as well as substance use disorder during the perinatal period. Screening for these disorders is only the first step; next steps are referrals to treatment and providing additional treatment if needed. For both these mental and physical disorders, platform treatments, which include patient education, clinician training, toolkits, event and appointment calendars, medication reminders, and in-app messaging features, have been shown to help patients be diagnosed, receive treatment, and adhere to treatment. However, these tools are not yet available for widespread use.

Facilitated Discussion: Community

Key points brought out in this panel:

• Equity, anti-racism, inclusivity, and anti-oppression should be embedded in all biomedical technologies designed for improving maternal health.
• To gain widespread use of technology that improves maternal health, end users of the technology should be engaged and included from the beginning of the technology development phase to co-design toward the users’ needs and technical ability.
• Development of technology for maternal health must be low-cost, easy to use, and widely accessible to all communities and people who can benefit from it.
• Developers should make technology flexible for different types of needs in different communities. For example, the ability to turn on and off different types of alarms helps to adjust the technology to a specific community or patient need and reduce alarm fatigue by patients and providers.
• Overall, the use of technology to improve maternal health is seen as a positive, however there are several challenges including: user-related challenges, business and financial challenges, and data access and security challenges.

The final session of the workshop was a facilitated community discussion to understand the needs of the community for technology in maternal health, as well as to recognize challenges related to technology development for this population and care team. The overarching point from the discussion is that technology is a tool which should be community- and people-centered. How individuals use those tools could contribute to better health and greater equality but could also have adverse effects as well. The people (e.g., midwives, doulas, nurses, public health lawyers, patients) behind the technology are just as important as the technology itself and prioritizing these individuals as new technology is developed and implemented is paramount to the success of the technology. Technology does not ensure equity unless the people using it do so. To ensure greater equity, patients and community members’ lived experiences need to be centered in order to collaborate on the development of maternal health technologies. The discussion pointed out several times that it is imperative that any technology developed must build on empathy and have equity, antiracism, inclusivity, and anti-oppression embedded into it. Accessibility of the technology is also an important issue. The goals of technology development for maternal health are to make it better for all patients and not to generate another type of inequality or compound inequalities that already exist. Technological solutions to improve maternal health also need to be intentionally developed to avoid increased surveillance of pregnant, capable people that could exacerbate current inequities such as criminalization or engagement of child welfare. Additionally, technology developed should not add an additional burden to patients but should be something tangible that they want to use. The consensus was that the best way in which to accomplish this is by engaging with the patients early and often in technology development to make sure it is patient-centered. The use of telehealth services was also discussed as an overall positive outcome for maternal health in that it has allowed for more patients to regularly schedule and keep appointments. The connection of telehealth appointments with connected and wearable devices and sensor devices should be further explored. While the overwhelming consensus is that technology development is a positive step for maternal health, there are several challenges that need to be taken into consideration: user-related challenges, business and financial challenges, and data access and security challenges.