Pregnancy care is poised for a 21st century upgrade.
[pullquote align='right' citation='Dr. Thomas McElrath']‘Frequently people want the reassurance that it’s fine, but they haven’t thought through what happens if something isn’t fine. ‘[/pullquote]

Algorithms promise to detect the difference between real labor and a false alarm. Wearables give women a way to track contractions. Apps relay home blood pressure readings directly to doctors, offering a possible way to cut down on prenatal visits — and catch certain pregnancy complications before they become full-blown crises.

Doctors say the new technologies have the potential to transform prenatal care. But for all the promise, doctors caution that some direct-to-consumer devices might cause anxiety or unnecessary trips to the clinic — without strong evidence that they offer any real benefits to pregnant women.

“Prenatal care is burdensome. It requires patients to be in at minimum, once a month. People have jobs. It’s hard to get in… You could imagine some kind of virtual substitute would be very welcome,” said Dr. Thomas McElrath, an obstetrician-gynecologist at Brigham and Women’s Hospital in Boston. “But we would have to figure out and think carefully about how to do that,” he added.

Obstetrician-gynecologists are particularly worried about direct-to-consumer devices that aren’t woven into the fabric of prenatal care. Among their concerns: Faulty or confusing data might send women to their doctors when they don’t need to go. And for some devices, doctors say the lack of research or a true need to use them means they’re simply a waste of money.

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“I [sometimes tell] my patients to save their money, because babies are expensive,” said Dr. LaVonne Simmons, an obstetrician-gynecologist at the University of Washington.

Their fears aren’t completely unfounded. Some women say they bought devices to give them more data about their pregnancy, but ultimately felt they were more of a headache than a help. Others say they raised false alarms or made them second-guess their gut instincts about what was happening in their bodies.

But other women say DTC devices have given them peace of mind and the feeling of more control during a time that can be biologically overwhelming. That’s fueling a growing tension: As pregnancy tech grows more popular with patients, doctors are left to figure out if and how such devices fit into a woman’s prenatal care.

“It’s clearly the way of the future,” said Dr. Nathaniel DeNicola, an OB-GYN at George Washington University “This is an enormously popular, highly utilized field … It’s not going away.”

A New Kind of Prenatal Care

The field of pregnancy tech has grown rapidly in recent years, from home ultrasounds that capture kicks to wearable belts that play music to the womb.

One popular device is Bloomlife, a sensor that’s designed to pick up uterine activity. Women stick the sensor three fingers below their belly buttons, sit still, and watch as uterine activity pops up in spiky peaks on the Bloomlife app. More than 10,000 women have rented Bloomlife’s $20-a-week “smart pregnancy tracker” to count millions of contractions since the company launched in 2014.

Bloomlife’s office is in downtown San Francisco, situated in a coworking space that doubles as a retail store, with space-age phone pods lined up next to vintage furniture for sale. The basement is a lab space that was repurposed from a photo processing lab once run for Ansel Adams. Now, Bloomlife is using it as home base as it tries to do for pregnancy what its Silicon Valley peers are doing in other areas of health: Give it the tech treatment.

“The way that we manage prenatal care fundamentally hasn’t changed in decades,” said Eric Dy, Bloomlife’s president and a biomedical engineer by training. “That’s our North Star — we believe we can define a new standard within prenatal care,” he added.

Because Bloomlife’s device hasn’t been approved by the FDA, the company is careful not to veer into medical advice. Many women use it simply to see what’s happening in their bodies. It’s popular among women who might live far from their providers — nearly half of users live in rural areas, according to a Bloomlife breakdown of users’ ZIP codes.

Going direct-to-consumer has allowed the company to collect a massive amount of data, Dy said. While the company only relays contraction data to users, the device also tracks maternal heart rate. Bloomlife now has what it says is the world’s biggest physiological data set during pregnancy, with more than 500,000 hours of data.

Bloomlife is using that data to train artificial intelligence algorithms to not just track contractions, but identify labor. That could have a big impact, given the high cost of hospital trips for false labor.

The company recently wrapped up an observational study to test the accuracy of a “digital biomarker” — specifically, data on uterine activity and heart rate variability — in 150 pregnant women who used Bloomlife’s device.

At a medical conference earlier this year, Bloomlife’s team presented an abstract on results from the first 50 women in the study. The company reported that it is able to detect if a woman is in labor with 80% sensitivity and 93% specificity. Bloomlife says that shows its device is as accurate as the current standard of tracking contraction patterns and conducting a pelvic exam.

But outside experts still have questions, starting with the results from the other 100 women in the study. McElrath, the OB-GYN in Boston, said the analytic technique used to crunch the data wasn’t as rigorous as it needs to be to prove the test is valid. He also pointed out many women don’t have contractions in a clear pattern until the end stages of preterm labor and delivery. At that point, he said, it’s likely too late for a tool like Bloomlife’s to be useful in identifying the onset of preterm labor.

Bloomlife says it is preparing the full results of the study for publication in a peer-reviewed journal. The company plans to apply for clearance from the FDA next year and wants to run more studies on the device’s potential use in prenatal care.

For now, though, the device continues to gain traction among women who say they like seeing data on their pregnancies.

“I thought this would be a good way to track things at home without staring at the clock,” said Christine Hall, a 32-year-old woman who lives in Fayetteville, Tennessee. Hall, who Bloomlife identified as a customer who could speak about her experience with its tracker, rented the device while pregnant with her fifth child. She started having contractions earlier than expected with previous pregnancies.

“For me, it really just brought peace of mind,” she said.

‘To a Patient, a False Positive Feels Very Real’

Despite the potential peace of mind, some doctors are wary about what might happen when patients are flooded with health data from devices that aren’t part of their medical care.

“Frequently people want the reassurance that it’s fine, but they haven’t thought through what happens if something isn’t fine,” said McElrath, the OB-GYN in Boston.

McElrath and other providers said they’re worried that direct-to-consumer pregnancy tech might cause unnecessary anxiety, particularly if they’re not reliable and sometimes signal something is wrong when it actually isn’t. Some devices, like home heart rate monitors or ultrasounds, are also prone to user error if a patient isn’t trained properly.

“The tact I take with [patients] is that this might actually increase anxiety. That’s my biggest concern with these devices,” said Simmons, the University of Washington OB-GYN.

Faulty results could also send women to their health care providers when they might not need to make the trip. OB-GYNs said they see patients who were using home fetal heart rate or activity monitors when they couldn’t pick up a heartbeat or saw less fetal movement than normal. The woman calls up a doctor, who isn’t sure how to interpret data she isn’t looking at from a device she isn’t familiar with. She asks the patient to come in, only to find that everything is fine.

“Then we’ve had a hospital visit and created an anxious patient. To a patient, a false positive feels very real. They don’t know it’s false,” said McElrath.

Doctors also noted that in the case of many pregnancy tech products, there’s not much data to show whether the tools can even improve health outcomes.

“All of this [risk] is acceptable if we know it’s for a good reason,” said McElrath. “When we’re not sure, it becomes a potential burden.”

That’s been the case for some women who have turned to tech while pregnant. Leah Hutson kept seeing Facebook ads for Bloomlife when pregnant with her first child. “I was like, this seems like it would be really cool. This is my first child, I want to be as informed as possible,” said Hutson, a 31-year-old who lives in San Antonio.

She started using the monitor in January 2018, about a month before her due date. It picked up some uterine activity she felt. But a few days before her daughter was born, Hutson started feeling uncomfortable and wasn’t sure what was going on. She put on her Bloomlife, but it didn’t pick up any contractions.

She bounced on a birth ball. She went to work. She took a trip to Target, hoping she could walk off the discomfort and grab some snacks for when she did go into labor. Hutson tried Bloomlife a few more times, but said she saw no activity.

“Turns out, during that time, I was actually in the beginning of labor,” she said. By the time she went to the hospital, Hutson was already 7 centimeters dilated.

“Bloomlife made me second guess myself. It wasn’t showing any contractions,” she said.

Tech Companies Court Providers as Customers

By and large, health care providers and patients all agree on one thing: Tech does have the potential to make pregnancy care far better — if it’s done the right way.

“It [should be] an entry to interacting with the medical environment, rather than having patients do this on their own,” said McElrath.

But McElrath and other clinicians said new tools demand more research. They want evidence that at-home devices are as good as existing care or even better. Providers also say device makers need to think carefully about how new technology will fit into a woman’s overall care.

“We’re going to [need] more integration with clinical oversight to help make it safer to manage all this patient-generated data,” said DeNicola, the George Washington University OB-GYN. DeNicola also serves as the chair of the telehealth committee at the American College of Obstetricians and Gynecologists.

Several companies are developing tech tools for clinicians that they hope will one day fit seamlessly into prenatal care. Rather than being shipped right to a pregnant woman’s door, the products would be “prescribed” by providers who send women home with the tools, monitor their data remotely, and help patients interpret it.

DeNicola has conducted research on one such system, called Babyscripts. Women measure their blood pressure, glucose levels, and weight at home, then log that information in the Babyscripts app. The app also asks users questions about their mental health during pregnancy.

Providers can see that data on a dashboard and call patients anytime something seems amiss. Women can keep using the app after birth, potentially giving providers a new way to see dangerous blood pressure problems after birth. An added bonus for clinicians, per the company’s website: “By automating elements of care, you can reduce the need for routine in-office visits while capturing the same global fee.”

Another company, Nuvo, has developed a wearable belt that doctors send home with women to keep tabs on maternal and fetal heart rate, along with uterine activity. A woman can’t use the device to see data outside of the scheduled times and tests set by her provider, which Nuvo hopes will prevent patients from poring over data on their own.

“We really believe in making the mother the point of care, and having the data seamlessly travel between the doctor’s office and the home,” said Debra Bass, the chief marketing officer of Nuvo.

Nuvo’s customer is the provider, not the patient. The company is eyeing maternal-fetal medicine specialists who care for women with high-risk pregnancies as its first target audience. The company knows it’s critical for its success to not only score the endorsement of clinicians, but also get them to adopt the technology.

To win over doctors — and demonstrate its efficacy — Nuvo has applied for FDA approval for its device, called Invu. As part of its application, the company ran two studies: one to demonstrate that the device works as well as existing tools to monitor heart rate, and one to show that it’s safe and simple for patients to use at home.

“We could have been another gadget that launched at the [Consumer Electronics Show and started selling on our website or Buy Buy Baby,” Bass said. “It’s been harder, longer, and a lot more expensive, but we believe [running trials] is the right and responsible approach,” she added.

Nuvo is expecting a decision from the agency later this year. Clinicians, meanwhile, are watching with anticipation as more research unfolds and regulators begin to review the new tools that have the potential to make prenatal care easier and more effective.

“The whole idea is to protect against the potential hazards, so then we can take advantage of all the benefits,” DeNicola said. “This has much more promise than peril.”

This story was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.

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