In March 2014, the San Antonio, Tx.-based mobility solutions vendor AirStrip announced that it acquired the assets of wireless monitoring startup Sense4Baby and licensed the associated technology that the startup was founded on from research from the Gary and Mary West Health Institute. The Sense4Baby system is used to perform remote maternal and fetal monitoring including for high-risk pregnancies.
Then, just a few months ago, the Food and Drug Administration (FDA) cleared the Sense4Baby wireless maternal/fetal monitoring system to be marketed for use in the U.S. by pregnant patients to self-administer non-stress tests (NSTs) or for use accompanied by medical professionals. Examples of these types of tests can include babies’ heart beats and mothers’ contractions in third trimester of pregnancies, as the technology tries to detect fetuses that are at high risk of stillbirth.
For both the obstetrics and gynecology world, as well as the health IT industry, the impact of this news is another sign towards taking clinical care out of the hospital and moving it into remote locations. "Patients may need to travel for extended periods of time, multiple times per week, in order to receive these tests," says Erin Clark, M.D., assistant professor of maternal/fetal medicine in the Department of Obstetrics and Gynecology at University of Utah Health Sciences. "At-home fetal monitoring may allow patients to save time and money related to travel for NSTs, and may also increase the capacity and flexibility of health systems to conduct NSTs,” Clark says.
In additional to her clinical medicine work, Clark is also associate director of University of Utah’s Obstetrics and Gynecology research department. She notes that a lot of her research focuses on genetic and environmental factors that contribute to preterm birth, but says she has spent increasing amounts of time focusing on developing novel and innovative strategies for administering prenatal care. That’s how the door opened for a new study at the university, which will test Sense4Baby in high-risk populations. “University of Utah [has become] very interested in innovative strategies for providing care with focus on value in clinical outcomes, cost effectiveness, and patient satisfaction,” Clark says.
“How do we provide the highest value of care in all these different areas? When it comes to providing prenatal care, we have done it pretty much the same way for the last 100 years,” she says. “We know that prenatal care, in its current format, which is about 15 face-to-face on site. There is no question that the care saves lives and is effective, but no one really knows what the best strategy is for providing this care,” she says. Clark notes that questions such as how many visits should there be, how many should be on site, and should stress tests in particular have to be in person all have been posed to shoe in the field. “Can we think about this in a new way that’s innovative with the same outcomes in a more cost-effective manner with potentially more satisfaction for providers and patients?” Clark asks.
The technology involved, says Clark, who admits she’s not the biggest “techie,” is essentially a small suitcase that contains the same monitoring equipment that is used in traditional prenatal monitoring, meaning it has a monitor in place that detects fetal heart rate, and also a monitor for contractions. The signal is then sent over an internet connection to a HIPAA-compliant web-based cloud that the care team could see, she explains. “The technology is not so different than what clinics use to send tracings to a doctor in another location to read. It’s very easy, once doctors see how easy it is to log in and see those tracings, they become converted quite quickly,” she says, adding that the monitoring provides an additional layer of protection compared to technology such as Skype.
Erin Clark, M.D.
As such, the study in which the University of Utah and AirStrip are participating in is focused on the administration of these non-stress tests. Clark says there are characteristics of the fetal heart rate tracing that can give clinicians clues that a baby is not doing as well in regards to oxygenation, for instance. “Hopefully we can then intervene and provide a better outcome,” she says. This has become a standard of care in obstetrics, and for women with high risk pregnancies, these tests have typically been administered once or twice a week, sometimes in a free-standing clinic or facility affiliated with the hospital, Clark notes.
The main question, Clark continues, became, could this could be accomplished in a way that made it feasible for a healthcare center? “We had faith in the technology, so feasibility was our primary question. We knew we could establish clinical algorithms to establish a safe practice to do these at home or off-site in general, but could we integrate it into the healthcare system? By integration, we mean can we schedule these tests, interpret them, bill them, and come up with these clinical algorithms that everyone finds acceptable? Can we build this into a system? Clark asks.