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Join Nathaniel DeNicola, MD, MSPH, FACOG, a board-certified Ob/Gyn and Assistant Professor of Obstetrics & Gynecology at The George Washington University Hospital in Washington, DC, as he leads a discussion for health care professionals on mHealth Apps in Pregnancy.

This event was recorded on April 17, 2018. It will require approximately one hour of your time.

 

 

Follow-Up Participant Questions:

Q: How do companies get by with the rules when it comes to apps, even though they aren’t supposed to make medical diagnosis (ex: this is my baby’s heart rate vs. my heart rate)? How do they get by with putting products out there like that?

A: At this point, there is really very little, if any, regulation. On the FDA’s website, they do have a whole laundry list of conditions they consider to be health care related that include all these different app categories – everything from remote monitoring to fitness apps. It’s a list that is very clearly not enforced in any means. Basically, it’s a wild west moment. There is almost no oversight to what the companies are advertising. That is one of the important reasons why Dr. Lowery (University of Arkansas for Medical Sciences) and I are working with the American College of Obstetricians and Gynecologists (ACOG) on the task force. We want to develop best practices, at least within our specialty.

Q: Where can people find information about the devices that you’ve used or the companies that you’ve mentioned in your presentation?

A: Some of them, especially those from the peer reviewed literature, are mentioned by name in the articles. So if you want to do a standard literature search and mention specific names like “Text for Baby”, there are dozens of studies that mention it. It has a host website that goes into great detail from what it was intended initially and how it has expanded now.

Honestly, one of the most fun ways to do it is to try it out for yourself. Some of these are apps can very easily be used by anybody. When I was first getting familiar with them, I pretended that I was pregnant and made up a due date, and I joined “Text for Baby”.  I would get a text message feedback. Actually, app developers encourage you to do that. Other devices, such as “Baby Scripts”, which is the remote monitoring platform, they have a website that goes into good detail about how the clinical integration is designed and how it can be tailored for each different practice, academic center, or hospital center.

There is not a central clearing house or online site to go and look for the best medical apps that are recommended by doctors. There are many articles you can find online with a google search that will rank the best pregnancy apps or fertility apps. Some articles are well written and give good background and some articles are more casual. One thing that is useful about reading those articles, though, is that it is much like going to the app store. It does show you some of the most popular and commonly used apps. So if you are looking to vet maybe 4 or 5 or a small number on your own, that gives you a pretty good starting point for where to spend your time.

Q: Have you used any of your apps in high-risk pregnant teens or women who have substance abuse problems?

A: I personally have not, but there is a good deal of literature about using apps, especially SMS text messaging, for the teenage population. It is an extremely effective way to increase a number of health outcomes. One of the most common is testing for STI’s, so if you want to get teenagers more engaged and get them to be tested, text messaging works. When it comes to smoking cessation among high-risk pregnancy teen or otherwise, there is good data that text messaging helps promote smoking cessation among high-risk patients.

There was a study being done at Penn (University of Pennsylvania) when I was there doing a fellowship, and it was using text message to communicate with patients who had a remote blood pressure device that was not linked via wifi. It was just a home blood pressure cuff, and the results were texted back and forth with the doctor and the patient. It was used postpartum, and it showed a great efficacy for replacing in person visits with just the remote blood pressure monitoring and texting the information.

For substance abuse, I’m assuming people mean things beyond tobacco use. I’m not familiar with any studies about illicit drugs or substance abuse. As I mentioned in lecture, there are many states exploring remote opioid treatment prescribing. You will probably see more of those papers coming out as it becomes more acceptable state by state.

Q: Is there a way to manage patients in remote locations with portable ultrasound technology?

A: This has been done in feasibility studies both in the U.S. and internationally.  Primarily, the feasibility studies have demonstrated feasibility. In other words, the information you were trying to gain in ultrasound, that would typically be done face-to-face or in the same building, can be done effectively remotely with either a tech or somebody else like a high-risk specialist connected remotely or somebody who is not a high-risk specialist doing ultrasound locally. There has been feasibility studies for those.

For fertility work, this is from pilot studies, but I think it’s pretty interesting – follow up accounts being done with ultrasound images being captured at home by the patients themselves. They equip patients with essentially a home ultrasound device, and the REI doctors can read the ultrasounds that patients do themselves remotely for follow up accounts. Neither one of these are large, randomized control trials but in terms of feasibility, it’s definitely being done.

Q: Do you see a future in patients doing their own ultrasounds at home? 

A: There are a few companies that I have encountered who are effectively trying to do the same thing for antenatal testing. There are more chronic diseases among pregnant women in general and in aging pregnant population. The indications for antenatal testing are becoming more common.  Yes, I definitely see a future for  antenatal testing being done in some more convenient way, whether it’s at home or some place closer than the doctor’s office. Antenatal testing usually includes an amniotic fluid index, which is from an ultrasound. I do think there is a way to do it that would get the information reliably and be more convenient.

Q: Do you have any experience with Bloomlife? It says on their website that they are the first and only pregnancy wearable? 

A: I am familiar with Bloomlife. They offer a variety of services. There are a few general categories. One would be pregnancy, typically pregnancy tracking. They give patients information based on gestational age. I have not worked with Boomlife in terms of their remote patient-generated data, but there are several companies that do it. “Baby Scripts” is the one that we worked with at George Washington. There was one featured in an NPR article called “OB Nest” that’s at Mayo Clinic, and they have a similar structure for monitoring blood pressure and weight gain. They also have a way to do fetal monitoring remotely. I believe Bloomlife also touches upon menstrual tracking.

I can’t say yes or no if that claim is accurate on their website, but I will say it’s a pretty common thing to see among the group – that they are first at something – and frankly, depending on how they phrase it, they might be right. A lot of these are very new companies. I’m not sure that I would focus on the first. I would more want to know how safe it is and that safety is connected to physician or provider interaction. Is there any clinical integration or not?

Q: Why is it so complicated at times to monitor a baby’s heart rate vs. a mother’s heart rate (for those not aware of obstetrics and the fetal heart rate differences)?

A:  The first is if the baby is in distress, the heart rate will be below its typical fetal heart rate range – roughly 110 to 160 for normal fetal heart rate range.  If the baby is in distress, it could be much lower than 110 or 120 and much closer to the maternal rate – 60 to 100 range. At precisely the time you need to know the baby’s heart rate when in distress, it could be most similar to the mom’s, which can be hard to distinguish.

The other thing is that it is a small organ in general, the fetus is small, the heart is a small target. With trained providers, it’s usually not hard to find the fetal heart rate, but sometimes you have to search for it. People who aren’t familiar with that may give up easily or think they found it without really getting the fetal heart rate but getting the maternal heart rate.

Q: Have you connected with any companies that store cord blood? 

A: The mhealth connection? No, I haven’t. I haven’t worked with any companies that are trying to make apps or remote connection part of their service. I have interacted with cord blood banking many times. I don’t have anything specific to say about that except for standard ACOG and the American Academy of Pediatrics (AAP) guidance, which is very limited. People benefit from individual banking or the more common public banking. As far as the mHealth connection, I have not seen it.