In this episode, we speculate about the near future of advancement of obstetrics, including new vaccines, new uses for cell-free DNA screening, advancement in diabetes monitoring, the use of artificial intelligence and remote monitoring in obstetrics, and artificial womb technology. Also, do you need to stick the GBS swab in you know where?
00:00:02 GBS Swab Technique
00:10:09 Emerging Innovations in Obstetrics
00:18:35 Advancements in Vaccines and Prenatal Care
00:27:49 Diabetes Management and Assisted Birth Advances
00:39:06 AI, Prenatal Care and Fetal Monitoring Advances
00:53:20 Advancements in Artificial Womb Technology
Follow us on Instagram @thinkingaboutobgyn.
In this episode, we speculate about the near future of advancement of obstetrics, including new vaccines, new uses for cell-free DNA screening, advancement in diabetes monitoring, the use of artificial intelligence and remote monitoring in obstetrics, and artificial womb technology. Also, do you need to stick the GBS swab in you know where?
00:00:02 GBS Swab Technique
00:10:09 Emerging Innovations in Obstetrics
00:18:35 Advancements in Vaccines and Prenatal Care
00:27:49 Diabetes Management and Assisted Birth Advances
00:39:06 AI, Prenatal Care and Fetal Monitoring Advances
00:53:20 Advancements in Artificial Womb Technology
Follow us on Instagram @thinkingaboutobgyn.
This is thinking about OBGYN with your hosts Antonia Roberts and Howard Harrell.
Howard:Antonia Howard. What are we thinking about on today's episode?
Antonia:Well, we're going to get a little futuristic and talk about some pretty cool advances that might be coming that could change how we practice obstetrics in a big way, and this will include a range of things, so different prenatal lab tests, immunizations, labor management innovations, and also neonatal or, I guess, fetal management. But I also understand you've been moonlighting on other podcasts, is that right? I?
Howard:do show up every now and again on other podcasts besides this one. But yeah, I was actually on a podcast a few months ago that was recently published at least published since we recorded our last episode. Some people don't know. We might record some of these in advance, but this is called a Good Omen podcast. We'll put a link to it. It's done by someone who's currently a med student and he does interview style episodes with different thought leaders on different subjects and they're really quite good. So he had read my book, clinical Reasoning, and he reached out and we did the episode and talked about a lot of things that I enjoy talking about, except from the book, and not necessarily a lot of stuff that we actually talk about that much on here, which might be surprising, but it was good.
Antonia:Yeah Well, I actually listened to that episode. I guess the name of the podcast is a play on his name. Yeah. So yeah, it was more of a philosophical discussion than what we normally do on this podcast, and you guys got into some of the core ideas in your Clinical Reasoning book. I think that they are very generalizable probably to all specialties in medicine. It didn't sound like this med student is trying to go into OB.
Howard:No, not necessarily yeah.
Antonia:Yeah, or he was at least drawing a lot of parallels to other specialties. So, yeah, we'll put a link to that episode for anyone who's interested. I'd at least encourage people to check it out. I was impressed that this med student put this all together that's more than I would have done as a med student and especially that he chose this specific topic to dive into. I think it's just very relatable for people at all levels in medicine.
Howard:Yeah, and we talked a lot offline too around that, and he's an impressive person, so good for him.
Antonia:Great, okay, well, so I guess you're just moonlighting, that's moonlighting yeah. Yeah Well, today on this episode we're going to talk about obstetrics and, like I said, futuristic stuff. But first, what's a thing we do for no reason?
Howard:All right. Well, how about placing the GBS swab actually into the anus, about a centimeters or so inside the anal sphincter, when we collect our culture for group B strep.
Antonia:Okay, I guess that's a little bit of a graphic way to describe it, but yeah, I think most of the listeners have done this or had it done to them, so they know what we're talking about.
Antonia:Or we even actually had visual diagrams in our exam rooms of how to do it, so the visual is very clear in my mind. So this is the typically described method of collecting the GBS sample, and that is where it's front to back, where it's inserted into the vagina and then dragged back and then inserted into the anus, and this technique is something that we've inherited from how the original study was done on it, like how we give Rogan within 72 hours, not because that's when it's actually most effective, but that's because of how it was originally studied, because those investigators couldn't see the prisoners who were the test subjects more than every 72 hours, so that was just their set time for practical reasons. So even now we still have this 72 hour time limit that we have to give our Rogan doses in on our protocols, just based on what these original study authors decided. So in this case, the group B strep collection was initially studied with this technique that we just mentioned, where you insert them to a very specific depth in the vagina and then in the anus.
Howard:You don't even want to say it again. Well, the discomfort with this is a good reason to talk about it. So there have been studies which looked at the performance of this test with different techniques or different mechanisms. Now I'm not arguing that we should collect vaginal swabs only this isn't a discussion of that or anal swabs only, or perineal swabs only. Collecting from both the vagina and the anus or perianus is definitely the way to go and that's way well established.
Howard:The question is simply do you have to stick this swab inside the anus or can you graze over it? So this was studied years ago in some smaller studies and more recently there was a systematic review and meta analysis of the that literature published in March of 2022, which compared the concordance positive concordance rates of vaginal perianal or vaginal perineal or vaginal rectal culture techniques, and they found that the vaginal perineal or vaginal perianal culture people use both terms, but they essentially mean just going through vagina over perineal body and grazing the anus. They found that was comparable to the vaginal rectal culture that you just described, but, of course, was associated with less discomfort for the patient.
Antonia:Yeah, so this meta analysis had roughly 600 patients total among all the studies that they analyzed and I think that their conclusion really validates the option of patients self-collecting their swabs, which has also separately been studied, where patients collect it and then the clinician also collects it and they compare and those are pretty much the same. So self-collection is another way that you can allow for more privacy to the patient if they choose that, and you can imagine if someone's collecting it themselves they might not be as likely to push the swab really deep. But also, even if they're not the ones doing it, if the nurse or the provider is the one doing the swab, it's still, like you said, much less uncomfortable than the original method and actually at one time in the early days of group B strep screening, a lot of doctors would put in a speculum in the vagina and then collect the group B strep swab from high up in the vagina, probably even from the cervix, and it already took a lot of education to get them to stop doing that.
Howard:Yeah Well, I've never used a speculum for getting a GBS culture. I have heard of people doing that and I also haven't inserted it into the swab, into the rectum for several years. Although we just mentioned some newer studies on this, there was actually a study in 2011 in the Green Journal which found that the GBS detection rates were similar between a vaginal rectal or vaginal perianal collection method, but almost, of course, three times as much pain with the vaginal rectal method. So most patients said that they would prefer the vaginal perianal method, so not inserting it inside them. I'll put a link to that paper, but, as I recall, that's when I stopped routinely inserting it into the rectum and just did the perianal collections.
Antonia:Okay, yeah, so this has been publicly available, published knowledge that in journals that we read that we should have all known for more than a decade. But even that 2011 study wasn't the first one to look at this question. So this meta-analysis we're talking about from 2022 is authored by someone who also published their own single trial on comparing these techniques in 2004 in the Green Journal, and, of course, that author included their trial into the meta-analysis. So that trial had 200 patients and again they found it's the same. You get the same result whether you push the swab inside or just swab from the outside of the rectum. And so they, already in 2004, concluded that pregnant women do not need to be subjected to the discomfort of getting rectally swabbed like this. And it's almost 20 years after that now, with multiple additional trials and a systematic review, so that really should put an end to inserting the swab higher than it needs to go, but I'm afraid this is probably still going to continue to be a commonplace practice.
Howard:Yeah, and I think the reason for that might be the same reason that doctors might tell patients to check their own IUD strings after their periods, for example. I think they're just worried that if that's what the product insert says, or that's what the FDA stipulated for the product, or that's what a textbook says or something like that or a guideline, then that's the way it has to be and as always will be, or that they open themselves up to some liability for not doing it. Now, to my knowledge, there's no product insert or FDA stipulation about how to collect a GBS swab. It's just one of those things that it's how we were taught and so we're going to keep doing it. But we don't need to deny the existence of consensus, of scientific data. It does get.
Howard:I think in our last episode we talked about a couple of examples of like when do the guidelines change? And frankly, no one wants to do the work of rewriting entire guidelines over some minor detail like should you take your strings or not, should you put an in or not, and there's lots of things like that that we know the right or better way to doing something, but it's not widely propagated just because there's no big onus to change. So right now in GBS, two more things that come to mind is the four hours. So if you get penicillin and you don't get four complete hours starting the second dose, then the right. Now the guideline says that the baby should be observed for the second 24 hour period, but we have good science that says that two hours is sufficient for that. Again, just based on the dosing of the GBS. That's the way the guideline was written, but no one's bothering to change that guideline or update that.
Antonia:Yeah.
Howard:Yeah, and then the other one I was thinking of is what we've talked about on here before, about ANSIF and the GBS thing. Right now, the guideline still assumes that if you are have a severe penicillin allergy or a bad airway, then you should go on to Clindamyacin.
Howard:. So it's going to take a lot of work actually, and maybe several years for CDC, and then everybody else subsequently, to change their guideline. But we know right now what the right thing to do is. So if you know what the right thing to do is, do it.
Antonia:I say yeah, I can already think of several other examples that fit what you're saying, but let's move on to talking about the future of OBGYN. I think this will be fun. It's, of course, nice to think about how far we have advanced over the generations in our field, especially when we read old textbooks or hear our really old attendings talking about what they used to do. But despite how far we've come, we're nowhere near any kind of pinnacle of where things could be or should be, even and I think this is just the general truth that applies to all sorts of well, all medical specialties in all non-medical areas as well.
Howard:Yeah, there's a tendency towards what I call the optimism bias, where we think we figured out all the past mistakes by previous generations, that we finally arrived and that we know so much more than we actually know. We also just get used to the way things are, like we were just talking about, especially when that knowledge is hard fought, like going through medical school and residency and spending a decade of our lives learning what to do with the GBS swab or whatever. I think that's one of the reasons why change does come so slowly and why so many doctors don't follow current evidence-based practices. What they do might once have been the evidence-based practice, but change is hard for folks and also just in general, people tend to be leery of change and rightfully so, but especially changes in technology or understandings of important concepts or pathophysiology things like that.
Howard:We learn a lot every five years in medicine. It is a completely different world, but people are hesitant. One of my favorite quotes about this concept of how we adapt to new knowledge or technology comes from Douglas Adams.
Antonia:The author of the Hitchhiker's Guide to the Galaxy right.
Howard:Okay. So now people are going to think we're both nerds. But yes, he wrote an essay in 1999 about the internet, which was just emerging, and about people's hesitancy about this new technology which to us today, with the internet such a part of our lives, seems weird. But of course people were very leery about what this meant. But it should remind you, I think, today, of how people view AI or other emerging things, emerging things in medicine, emerging things in society.
Howard:Anyway, he said in that essay and I'll put a link to the essay if you're curious, but this is his quote his three rules.
Howard:Number one anything that is in the world when you're born is normal and ordinary and it's just a natural part of the way the world works. Number two anything that's invented between when you're 15 and 35 is new and exciting and revolutionary and you can probably get a career in it. And number three anything invented after you're 35 is against the natural order of things. Apply this list to movies, rock music, word processors, mobile phones to work out how old you are. So I think we can apply his Adams rules of three to obstetrics as well. Whatever you learned about in med school and residency is the normal and ordinary way things are and anything that emerges early in your career is exciting and revolutionary and you may be adopted too soon, actually, because it is exciting and revolutionary. But after you get settled in and you're comfortable in your practice and you assume you know everything when that 35 to 40 year old age range or whatever it is, then you're probably not going to change again after that.
Antonia:Yep. But of course, even after we're 40, and no matter how much we resist these changes, the change is going to happen anyway, whether we like it or not. So the best way to see that over time and see that these changes not a new thing, it's almost like a constant is to study the history of obstetrics or anything else that you're interested in frankly and see how starkly different things are decade by decade, and then especially century by century, and realize that humans have always been and always will be resistant to changes, especially after they get established in their ways. So we're just being vague and philosophical right now. So let's get into some of these specific innovations for obstetrics that we might actually see happening within the near future, or at least in our careers.
Howard:Yeah, and some are happening right now. So one thing that's brand new, literally as we're recording this, is the recommendation about the RSV vaccine for pregnancy.
Antonia:Yeah, I think this is neat and it's just all of a sudden become very relevant in our daily practices here.
Antonia:In August 2023, the FDA approved a vaccine Abrisvo, so it's RSV pre-F vaccine for pregnant people as a single dose between 32 to 36 weeks of gestation to prevent RSV associated lower respiratory tract disease in their infants up to age six months, and probably also for the pregnant women themselves. I don't think we've ever really been worried that pregnant women are going to get RSV and get really sick from it, but it really hits the babies pretty badly, so it can be fatal in newborns, and so vaccinating pregnant women and having the passive transfer of their antibodies has been shown to significantly reduce the rates of newborn or infant RSV disease until about six months. And we've seen this very same effect of immunizing the mom with the COVID vaccines and the flu vaccines during pregnancy, and it's also why we give the TDAP booster. These are all things that protect both the mom and the baby, but we're giving it at least the TDAP. We're specifically giving it in the third trimester to protect their baby.
Howard:Right, as we would with RSV, because again, we're not super worried about the mother getting the diseases, but for the babies.
Howard:So yeah, we're seeing more and more how beneficial vaccines can be as part of our pregnancy management.
Howard:These vaccines given during pregnancy have an amazing track record of safety and efficacy for preventing the diseases that we're talking about in the newborns.
Howard:That brings us to another emerging idea, and one that we may see very soon, but this is a vaccine for group B strep.
Howard:So again, we just talked about group B strep swabs, but imagine a world where women were just vaccinated against group B strep during or maybe before their pregnancies. That would probably make most antibiotic use during labor for GBS chemoprophylaxis unnecessary, and it would also go a long way to dealing with problems that we still have about exactly when to time the swab so that we get the best results and minimize false negatives. And then, of course, just not giving millions of doses of penicillin or other antibiotics to women in labor every year in the United States, and that has all sorts of ramifications not giving it. Does that's a benefit for the mother of not having those doses and maybe the baby, in particular when you think about GI flora for the mom and the baby and how the flora and the baby is seeded and just other issues of developing antibiotic resistance in newborns and infections in newborns that are increasingly resistant to some of our common antibiotics because of how much antibiotics we're using. So a vaccine prevents all of that and makes all that unnecessary. Seems like a no brainer.
Antonia:Yeah, we'll include a link to an article in the New England Journal of Medicine from July of 2023 that discusses a potential group B strep vaccine in more detail.
Antonia:This has been under discussion for a long time, but in this article they report some promising phase two clinical trial results for one of the vaccines that's currently being developed for this and they also note I think this is probably the biggest selling point actually they also note that this vaccine would help not only with the early onset group B strep subsist in the newborn, which usually you would catch within the first 48 hours of life, but also with late onset group B strep sepsis and meningitis that can occur up to three months after birth.
Antonia:And if listeners, they may remember that our current practice of screening and then treating in labor does nothing against late onset group B strep sepsis. They can be group B strep negative or they can be appropriately treated and go home and then two months, three months later still develop sepsis and it's likely not due to a labor exposure. But if the mother's been vaccinated then it will protect the baby. So I think if you just suggest it to most people, like most people are not going to be group B strep positive. I think it's somewhere between 20 to 40%, and if it's just about whether or not to get antibiotics and labor, some people might say I don't want the vaccine, but I think protecting against a possibly fatal infection later on is a great selling point for it.
Howard:Yeah, and avoiding those antibiotics which arguably do have a significant role in the microbiota of the newborns and the mothers, and our antibiotic resistance issues and just cost and potential allergy exposures and all those things.
Antonia:So yeah, so on the whole it seems like an obvious win-win situation. But, like I just alluded to, our biggest issue is how do we get pregnant women to accept yet another vaccine, just increasing vaccines. I've already been talking about the RSV vaccine and I'm not seeing a lot of excitement in my patients about it. I think even just getting them to do the routine vaccine sometimes the T-dap and the flu is hard enough, and I think it's because there's just so much misinformation about vaccine safety out there.
Howard:Yeah, on the Facebook mommy groups and the internet and everything else and that's always a problem and unfortunately vaccine hesitancy discourages companies and folks from doing future vaccine development and it certainly discourages vaccine adoption.
Howard:Australia is able now to delay the first pap smear to age 25, because they've had such huge success with Gardasil utilization that they've practically eliminated cervical cancer, especially in younger folks in their country. But we struggle to get folks to use vaccines in this country at all, practically due to so much misinformation in lives about vaccine safety. I do think I'll say this and the hate mail will flow but the antibiotics for the penicillin for group B strep is more dangerous than a vaccine for group B strep would be. But people don't really understand that. They don't understand these concepts very well and we live in an age of misinformation about it. Remember that the leading cause of death among pregnant women over the last three or so years was COVID and almost all those deaths would have been prevented by vaccination. So as we enter into flu season now, we can also remember that most years one of the leading causes of death in these months in particular is respiratory infections due to flu. And again, almost all of that's preventable but people are increasingly choosing not to get vaccines.
Antonia:Well, we can mention just briefly here too in addition to a possible group B strep vaccine and the RSV vaccine that is out, there are a number of other vaccines being developed and trialed in pregnant women, including CMV, zika, ebola and malaria, and I don't think all of those necessarily would find their way into widespread use in the United States, except maybe the CMV vaccine, because it can still infect people, especially people that are either in healthcare settings or take care of young children. Cmv goes around a lot and it can cause developmental abnormalities or fetal death, but you can imagine how those other ones would be really helpful in developing nations.
Howard:Yeah, if we look at Africa or other countries where malaria is still endemic, for example, that's a leading cause of maternal and neonatal death and a vaccine would be tremendous. It would prevent an enormous amount of lost life.
Antonia:All right. Well, let's move on from vaccines. Another big technological advance in obstetrics or in prenatal care has been self-re-DNA technology for noninvasive prenatal screening for Down syndrome and other trisomies 13 and 18, and sex chromosome abnormalities, and we've talked on here before about some of the pros and cons of these tests, and we've also touched on some other more expanded uses of that same testing technology to look for other genetic diseases which so far have not proven quite so valuable as screening in the general population, because all those other diseases are way much more rare than even Down syndrome is already rare enough, but all the other things are even more rare, and so most of the time if it's a positive result it's going to be a false positive and that's just not helpful at all.
Howard:Right, and the problem, if listeners recall when we discussed that before, is that when you're screening for those diseases that have such a low incidence on the scale of 1 per 10,000 or 20,000 pregnancies, for example almost all of the positive results you get will be false discoveries or false positives in a slight misuse of the term. But if you have clinical suspicion of a genetic problem based upon family history or other findings maybe ultrasound findings, things like that and your pre-test probability is higher, then self-re-DNA technology can be used very effectively, as long as we again, like we do with Down syndrome, understand the positive predictive values or the we have to calculate based on our pre-test probability. So there are great instances where this can be used for diagnostic purposes.
Antonia:Yeah, so some of the already available uses for this kind of testing is looking for Cru du-Chat syndrome. So let's say someone already has another kid that was affected that they're probably at elevated risk and this is a nice way to test for it without doing an amniocentesis or Angelman or Prater-Willi syndrome. But in theory almost any genetic disease could be tested for and of course some company is going to come up with a way to do that.
Howard:Yeah, Everybody's working on it. I mean I don't think it'll be too long, for we have whole genomes and then we'll have to constantly remind folks that these tests don't have a lot of value unless the thing you're thinking about has a sufficiently high pre-test probability for this disease. So again, if they have a family history or a sibling, or the mother carry is a carrier or something like that. So I think in the next few years we'll have lots of ethical discussions about how to utilize more and more of these tests as they become available commercially and companies will sell them without those conversations. They'll want everybody to get them all the time. So we'll have plenty of information to talk about on the podcast.
Antonia:Yeah, and plenty to talk about just in our daily clinic patient encounters, I'm sure. But one other place this is already being used is for determining the fetal blood type in RH status. So we just had a thing about Rhogam on a recent episode. So testing cell-free DNA in the pregnant mother would be another way to tell prenately whether an RH negative mother is going to need Rhogam or not, or follow up monitoring of the baby for the fetus.
Howard:Right, and this is already a real product, though it's mostly used outside of the United States. So if the mother were RH negative, then we could order this non-invasive test and determine the fetal blood type and perhaps save her unnecessary administration of Rogam injections. Or, more importantly, if she's RH negative and antibody positive and we're worried about following the pregnancy for potential isoimmuinization due to that, then we could easily test the fetal blood well, the maternal blood and get the fetal DNA in an non-invasive way and find out if the fetus is RH positive or negative. And so for a good number of pregnancies we might discover that the fetus is RH negative and there's no extra concern warranted because the mother's antibody positive and all that extra testing becomes unnecessary.
Antonia:Yeah. So although this is being used in the world, in other countries outside the US, I found a policy with Blue Cross, blue Shield from March of 2023. So they're a major health insurance company in the US. They actually insure me as well and a lot of my patients. But in this statement they're saying they won't pay for this testing because the false negative rate is not zero. So because you could get false negatives from it, they think it's not worth paying for. They're worried that getting false negatives might lead to under-treatment with Rhogam or perhaps not be appropriate monitoring for pregnancies that are actually isoimmunized and we didn't know because of the false negative.
Howard:Yeah, and I get that, though I think the false negative rate isn't zero for any of our methods for determining fetal blood type either, and we just have to debate the merits of not giving Rhogam to more women, apart from even that case of potential iso-immunization. And right now, frankly, it's cheaper to pay for Rhogam for every patient than it is to pay for cell-free DNA technology to test the baby's blood type. That might limit giving Rhogam to just one in four or five of the patients who otherwise would be candidate of it. So it's just a monetary thing, I think mostly they. Also, blue Cross and other insurers didn't pay for cell-free testing for aneuploid a few years ago too, for similar statements. So I do think that this will change over time and perhaps in the near future, and this technology will become more common place in the next few years.
Antonia:Yeah, maybe once the science becomes really well established and the costs become more favorable, though, they can reevaluate their stance. Well, let's move on to another item of antenatal management that we've been seeing more studies on, and that's continuous loop diabetes management systems, at least for pre-existing pregnant diabetics, and I'll let you take the lead on this one, since you're our resident diabetic here. I'm an attending diabetic, thank you, Okay, right, yeah, you might as well be an honorary PhD in being diabetic.
Howard:I'll have to think of something those letters stand for. But yes, already we're seeing really great advances in the technology of combining continuous glucose monitors with insulin pumps that have some predictive software in it that helps to dose insulin in real time to prevent high and low blood sugars. So companies are bringing this out in various levels of sophistication. It's been rather slow moving in the last few years because I think companies are obviously worried about liability of having software dose your insulin without your input, giving the wrong dose and maybe causing a low blood sugar or something like that or a high blood sugar, especially in pregnancy where a high blood sugar could cause real problems. But the technologies here it's getting better quickly year by year. Each generation of continuous glucose monitor and pumps are really pushing the limits of what's possible here, and so we've come a long way, frankly, with how we manage diabetes in pregnancy.
Howard:I ordered a new copy of Gabby's Obstetrics the new edition recently and I was telling my med student about Stephen Gabby, who himself was a type one diabetic and became interested in that early in his career and is the founder in many ways of maternal fetal medicine, which one of the big problems that they were solving before ultrasound existed was improving diabetes management in pregnancy, and Dr Gabby had a lot to do with it. And now it's amazing. So we at least have the knowledge and technology available to almost normalize pregnancy outcomes with this technology and even with what we're doing right now. But we still have lots of macrosomic babies. Unfortunately, it doesn't make the babies necessarily smaller, but the days that Dr Gabby saw early in his career of dealing with babies who died of acidosis routinely or died in labor because those babies were 13 pounds and, if we go back far enough, c-sections weren't widely done or available, those days are long behind us, as long as patients take our advice about being judicious with their blood sugar management.
Antonia:Yeah, I can definitely think of some patients that just would not. They just cannot check their blood sugars four times a day and then stick themselves with insulin multiple times a day. It just doesn't fit for them. They just couldn't do it wouldn't do it. But if they had something like this that's just stuck on their arm constantly monitoring and dosing without them having to do almost anything, it would help those kind of people too. But that's not really. That's not why these things are being developed, but that would be a side benefit.
Howard:No, it is, though, too, because a lot of people, frankly, they don't do great at managing their diets and dosing correctly, or whatever, and this can overcome some of that.
Antonia:Yeah, well, there's already a lot of studies showing that the continuous glucose monitors do improve outcomes in pregnant women with preexisting diabetes.
Antonia:This is and this continuous monitoring is separate from continuous automated insulin dosing, but then those that also have insulin pumps also have improved outcomes, and this is really restricted to use in type one pregnant diabetics. But when you combine those two things together, there was a study published recently in Diabetes Care that looked at this. It was an open label, randomized, controlled trial of postpartum type one diabetics and they had both a continuous monitor and an insulin pump that communicated with each other, and this was studied mainly to look at safety concerns. They only had 18 participants but they did appear to minimize hypoglycemia. They had no episodes of severe hypoglycemia and no DKA. But trials like this that are small, more like pilot or proof of concept trials that are using the very latest models of pumps and continuous monitors, are meant to ease our way into doing the real studies in pregnant women, especially randomized, controlled like. Imagine studying this compared to the usual care where you just stick your finger four times a day and then give yourself insulin.
Howard:Or even to current versions that don't have this sort of intelligence driven, ai driven glucose management systems.
Howard:And yeah, so that study had really stuff that's barely available on the market. But actually a couple of weeks ago in the New England Journal of Medicine there was a study published that looked at automated insulin delivery systems of stuff that's commercially available now and widely used in women with pregnancies complicated by type one diabetes, and they had 124 pregnant women in this study and they found an improvement in glucose control, with lower hemoglobin A1Cs and less time in a hyperglycemic state, with more overnight time in the target range and very few episodes of hypoglycemia and they had no safety issues. I will say when we talk about time and range, that's going to replace for people with continuous glucose monitoring. Time and range is going to replace what we talk about in terms of A1Cs and so a lot of our literature is changing to that.
Howard:It's total percent, time and range that we'll be focusing on more and more in the next few years.
Antonia:Yeah, that study used a slightly different and slightly older scent pump and glucose monitoring system than in that study of the postpartum women that I just mentioned. So maybe this is already looking at something that's more feasible because it's more available right now, but that technology is continuing to get better with each new update and each generation of the continuous monitoring and dosing systems.
Howard:And, just as the companies in the FDA are willing to let the software make the decisions, that's a slow safety rollout. Practically speaking, a lot of us are already using some version of this technology. I have a T-Slim insulin pump and it has software that corrects dosing based upon feedback from my continuous glucose monitor, and it does that without my input, so it's already on the market. I recently had a type 1 diabetic who has the exact same system and she did very well using that system, though she did still have a 10 pound baby.
Howard:But this new study in the New England Journal of Medicine does appear to have smaller babies, which I thought was interesting. But there was also a few days difference in the time to delivery. The CGM babies, or the closed lip babies, were a few days earlier, so they might have been smaller. Based upon that and we'll see, that's maybe too small a number to draw a conclusion about whether this will actually impact fetal size. But, as you said, this is only getting better and better and more refined and we're just now living in the era of AI in the last couple years, and so I think this is going to continue to improve fairly rapidly and change how we manage type 1 diabetes and just poorly controlled type 2 diabetics are all pre-existing diabetics in pregnancy.
Antonia:Yeah, so at least wherever there's the right kind of support. I think when this first rolls out, I think it'll be more of a multidisciplinary thing and you'll need a lot of technological troubleshooting support. So that might not be as close on the horizon in, let's say, low income countries yet, but maybe not too much later. But the goal would be one to prevent acidosis and to prevent hypoglycemic episodes. Not necessarily to prevent large babies that might still happen no matter what. But as long as they're not hypoglycemic or acidotic, then it's still a victory. So I think soon enough it likely will be the expectation that somebody who's taking care of this pregnant diabetic patient whether it's me, the general OBGYN or even the midwife or a high-risk consultant or endocrinologist somebody is going to have to be an expert in these continuous either monitoring or pump or both closed loop systems and be able to manage and troubleshoot it appropriately.
Howard:Right, and that's. There's some learning to be done, so I'll say as a general commentary that a lot of folks prescribing these aren't very adept at it. So yeah education to follow.
Antonia:Yes, okay. Well, let's move on again. Another new device that hopefully we'll see in the near future. I think this is really cool. It's called the Odon device for assisted vaginal deliveries and, in contrast to what all the things we've just talked about up until now, this one is actually quite simple and low tech and feasible for widespread use, including low income and maybe especially low income countries, and it likely is safer than forceps or vacuums for assisted vaginal deliveries. So there's a paper from July twenty twenty three, published by the World Health Organization, that reports on this device, and it just seems really promising and really exciting.
Howard:Yeah, I think we're still a couple of larger trials away from this being widely available in the United States, but it is a clever idea and their initial data from international stuff is good. So this device has an inserter that slowly stretches a soft plastic tube I guess for lack of a better word around the baby's head all the way below the chin to encompasses the whole head. It's really more like a plastic sleeve that's inflatable. I think of it like a puffy Chinese finger trap, if you ever played with those toys and once it's around the head it doesn't need suction to pull the head out. The sleeve gets inflated. Then you just use this plastic device to apply pressure evenly and distribute it all the way around the head as you pull the device out.
Howard:This both prevents disengagement or pop offs that you might have with a vacuum, as well as suction related scalp swellings and injuries, things like that. It also avoids a lot of the maternal or fetal injuries that you might see with forceps due to their rigid structure. So it's potentially a great idea and I do think that we'll see it on the market eventually in the United States in the next few years. Once we've had appropriate trials here. It'll probably start, though, in developing nations, and that's why you see the World Health Organization. They're the ones that did this paper, they're the ones really taking the lead on the device as a way of helping in developing nations where it's really needed. So the article that we'll put a link to has great pictures of how to use this, because I'm sure that if just listening to the description, people are dumbfounded. But take a look at that and look at the pictures.
Antonia:Yeah, honestly, I've looked at the pictures and I've even watched a video and even with that it's a struggle for me to understand. There's just some really interesting physics behind it and I think it's cool that it was developed by an auto mechanic he got the idea from. Apparently there's this party trick where if there's a wine cork that's stuck in the neck of a bottle and you push it into the bottle, you're not going to be able to get it out just with your fingers. It's going to get stuck in the neck of the bottle. But there's this trick where if you shove a plastic bag into the bottle, inflate the bag and then you have the wine cork follow next to the bag, Pull that inflated bag out. Somehow the suction effect will pull the wine cork out through this really tight passage, and so he just got the idea that this could help babies be born.
Antonia:He didn't even really know about childbirth, but then he just got obsessed with it and developed it for years. And here we are. But there's video clips of this party trick with the wine bottle and also video clips, obviously, of the O'Donne device being used on mannequins. So I'd encourage people to look at both of those. It's almost like an optical illusion.
Howard:Yeah, I guess you didn't spend enough time in your residency playing with wine bottles. I love stories like this, though, because it really shows where innovation usually comes from the intersection of unrelated fields of thought. Yeah, yeah so we might not have ever thought of this, but someone from an outside field of thought looks at it and applies it, and that's really true if you look in the history of medicine or science in general, technology, etc. Most new innovations come from an outsider.
Antonia:Yeah, I mean I thought I played with wine bottles too much in residency, but maybe not. But anyway I'm glad that this mechanic guy pursued his idea. It's taken years and I'm sure he's. I doubt he's getting much money for it or I don't know, maybe he is.
Howard:Yeah, bottomless mimosas is not wine bottles, I'll just tell you Okay, okay, I did see recently that a store, I think in somewhere in California, or restaurant that has bottomless mimosas is going to start charging a premium if you throw up, before leaving the premises, a tax for people who drink too many.
Antonia:It's got to go in with some sofra and just okay. Well, let's move on. Those days are in the past. I get a headache from just looking at alcohol, yeah.
Antonia:Yeah, so recently in another episode, we talked about the frequency of prenatal visits. So there's, of course, some emerging things here as well that we'll probably see more of in the coming years. So a couple of things that make less frequent prenatal visits feasible are doing virtual visits and also using home monitoring technology, and both of these things already exist and are already in use. They're already developed. We really just have to figure out how to use them more optimally, because there's still lots of potential. But, as we mentioned before, we'll probably be seeing more visits converted to virtual, when the mother can weigh herself on a validated scale at home and just transmit it to the record and then check her blood pressure with a validated cuff, and then, if we want to include, we can even have a little Doppler and have her chip the baby's heartbeat if we want to include that.
Howard:I definitely think that those things are going to happen. It's positive for access to care and that's going to solve some of the problems that we're seeing with physician shortages and all these access issues and cost issues.
Howard:Once those devices are more widely available and cost effective and validated and we understand how to use them, then this is all a no-brainer. I also think we'll see more progress in as we mentioned too in that episode about prediction of preeclampsia. A lot of folks are interested in what analytes ultrasound findings, historical findings, like what rubric can be made that will help us predict preeclampsia. But even if we don't have that, younger patients today have grown up in the era of apps and telehealth and all that's a natural thing, extension of those technologies for younger pregnant patients today. I think they'll get half their visits done virtually within the next few years.
Antonia:Yeah, and another thing that will come about increasingly is the use of artificial intelligence technology for patient education, maybe even triage and other clinical roles that those apps can have built in.
Howard:Right. A patient will be able to text an AI bot and ask common questions that the AI bot will answer for her in a natural and conversational style. These apps already exist, by the way, for lots of customer service applications and mental health, for example, and they're being improved with newer predictive AI technologies that we've seen really emerge in the last couple of years. But more patient education will be done virtually with or without AI, which will be good for women because they can access it when and where they want and whenever questions pop into their mind, rather than waiting to ask a question once a month in a doctor's office or trekking out to the emergency department or triage because they weren't sure if they should be worried. But the AI element really adds a personal touch, so that these answers are tailored to the patient's specific questions and even to her specific risk factors. The AI is aware of her chart, aware that she's a previous C-section or that she has particular medical issues or whatever. All that can be calculated in to how it interacts with patients.
Antonia:Yeah, and speaking of AI, I think that'll also be used for lots of other things, including fetal heart rate interpretation, and there's a lot of work being done using computerized interpretations of fetal heart rate to try to improve neonatal outcomes while lowering the caesarean rate.
Howard:Yes, we have to separate out what's been studied for the last decade or more of computer-assisted monitoring and interpretation from what artificial intelligence might be capable of. So, for example, there was a large trial called the Infant Study, published five years or so ago. That was an RTC trial of computerized interpretation of fetal heart rates during labor conducted in the United Kingdom. This was using technology that was created in 2010. They did enroll something like 46,000 women in it and they found that computer rated decisions, support and alerts just weren't helpful in improving outcomes. There are some companies that have integrated alerts and things like that into their software. We have it at my hospital but so far they've not proven again to be valuable.
Howard:You're not going to see outcomes improved from these things, but it's a whole new world in the last couple of years with predictive AI, which really does excel at pattern recognition. So we're still waiting on studies with that element of it and I think we'll see AI interpretation of fetal heart rates become very commonplace in the next few years. The bigger problem in general is just that we've discussed before that fetal heart rate tracings aren't really predictive of pregnancies at risk, except in extreme cases those category three type tracings, so outcomes due to abnormalities that are not related to intrapartum events during labor, like fetal strokes or congenital anomalies or infections or other things that do cause most of the cerebral palsy and intellectual disabilities. So nothing's going to make that better, because we're trying to read something that can't be read any better and we don't need AI or computers to tell what a category three tracing is.
Howard:It's the category two stuff that, as we've talked about, probably just doesn't make a dent. So the goal, I think, is again, we have to change what we're looking for here. The goal isn't necessarily that we're going to find lower rates of cerebral palsy or fetal death or something like that, but just a lower cesarean delivery rate by using some AI, augmented interpretation that can be standardized and folks can feel comfortable because the AI says they don't need a C-section perhaps, and so I think that's what we might see in the future.
Antonia:Yeah, and we may also maybe see advances in centralized, remote monitoring of fetal tracings done by people rather than AI.
Antonia:This is already happening with some larger institutions, but if you can imagine, an air traffic controller person where it's either an obstetrician or maybe even some kind of advanced nurse, is sitting there constantly monitoring the fetal tracings of women in labor at multiple different hospitals, maybe even different hospital systems, and then whenever they see something that looks concerning, they can make a phone call to make sure that those abnormalities are being addressed.
Antonia:So this has an economy of scale effect. So and it can bring more than one set of eyes on fetal tracings, and I think most units already have their nurses station with all of the monitors on the unit up and the nurses sitting there are constantly watching. But this would be even another set of eyes and I think any hospital where there isn't a provider available 24 seven to watch tracings. This could significantly improve safety and reduce lawsuits. Because this could apply to a large hospital that's got multiple L&D units and the teams are just running around back and forth doing deliveries here, surgeries, there, that sometimes something can be missed. But the same thing can happen with a smaller hospital that maybe only has a handful or one or two providers, and they're assigned to do three different things at once there in clinic and in the OR and on call. They can't watch this stuff either, and so then in both of those situations it all comes down to a nurse that's constantly watching who also has a thousand things to do.
Antonia:Yeah yeah, there are easily be distracted. Yeah, yeah.
Howard:Another thing related to fetal monitoring that already exists but I think will become more commonplace very soon are adhesive patches that don't need to be adjusted, that measure the fetal heart rate and the contractions wirelessly. So General Electric already has a product called the Novii wireless patch system and this uses four little adhesive patches look like EKG patches on the mother's abdomen to continuously measure the fetal heart rate, the maternal heart rate and uterine contractions. And it doesn't need to be repositioned it doesn't ever. You don't have to change it at all. So that at least makes the nurses job a lot easier and helps to provide continuous data that you're not going to lose your tracing during an epidural. Or it's waterproof. They can get in a tub, but the big thing is no need to constantly readjust it and no belts, by the way, for the mother. So I think this will become a common place in the next few years, just because it's a manpower saver or woman power saver.
Howard:Okay, well, I'll have. There are male OBGYN nurses, but sure.
Antonia:Okay, sure, they are unfortunately a rare breed, but yeah, let's include all of them. Let's save the power of all the genders that are working for us.
Howard:And again, those things may not improve the outcomes, but they help with our process. They're pragmatic, pragmatically beneficial. So I think they'll happen.
Antonia:Right and they still don't solve the bigger problem, which is our over reliance on fetal heart tracings to begin with to in the hope that would prevent adverse outcomes, which they really don't. We've already talked about how especially continuous fetal monitoring and low risk patients is no better than intermittent monitoring, and that any monitoring in general really has failed to reduce the rates of cerebral palsy ever since we started doing it in the 1970s and made it our kind of universal practice. So even as we look at these things like the Novi wireless patches or other ways to make external fetal monitoring more precise and easy, we always need to consider that maybe we could just be perpetuating bad practices.
Howard:Yeah, I think we are, but we're medically, legally and culturally stuck with it as it for now, regardless. So it's just not realistic to think we're going to do away with monitoring at this point. I do think you could program it to where it just sampled it after a contraction every 15 minutes, for example, and ignore the other data.
Antonia:That could be a thing.
Howard:So, but I still see them as being commonplace. Again, just because of the pragmatic issues. Talk to a labor and delivery nurse about readjusting fetal monitoring, all monitors all the time.
Howard:Another thing I think we'll see increasingly in the near future is the practice of outpatient cervical ripening. So we've talked I think we talked about this briefly before but using, for example, a cervical catheter on an outpatient basis for induction of labor, and a growing body of literature shows that this is safe and effective and cost effective in particular, and so I think we'll see more of that.
Antonia:Yeah.
Antonia:So if you have a low risk pregnancy with an unfavorable cervix and they need induction, then you could put in the cervical foley in the office and then send her home with some instructions to come back either when she is in active labor or when the catheter falls out or her membrane's rupture, or just after a certain amount of time, and ultimately maybe this would save an average of a half day being admitted in the hospital, hooked up to monitors et cetera, which is how the alternative is to come and be admitted and then put in the catheter and then be monitored the whole time.
Antonia:So if that part is done at home, you could save the patient maybe 12 hours in the hospital, and so if you build that on a larger scale into the workflow properly, that could be another huge way to save on the nursing workload and the hospital and the hospital resources without adding risk to the patient. So it's worth looking at the existing studies carefully if you're going to adopt this, so you know which patients it's most appropriate for and how to fit it into your practice, because it's not like you some places, it's not like you can just add this on and have all your scheduled inductions. And then, in addition at this, because then you could suddenly be flooded with all these extra outpatient foley people at an inopportune time.
Howard:Yeah, you don't want to surprise your labor and delivery with eight inductions that you get at Friday afternoon in your clinic, still emerging and still waiting on some guidelines and some work around this, but it's happening, okay.
Howard:Another one that we might see is more objective markers of labor progression.
Howard:So for now we basically rely on digital cervical exams to tell how dilated you are with the station and the fetal head is things like that. We've talked before about using ultrasound for prediction of the angle of progression, but we also talked about objective measurements of descent, which was as valuable, if not more valuable, using ultrasound, and how that might at least help us understand about the need for operative delivery or avoiding operative delivery in favor of cesarean for second stage problems. But there's lots of other ideas that have been around that either use ultrasound to more objectively understand how labor is progressing or things like less invasive cervical monitoring, including of the station. There have been products developed that will give objective measures of those dilating cervix and of the station of the fetal head. I do think that, for better or worse, we're going to see companies promote some of these items. In particular, ultrasound monitoring of labor progression. Right now is getting a lot of literature, so it's probably just a matter of time before we see it utilize more and more, particularly with abnormal labors.
Antonia:Yeah, and hopefully that could be one way to reduce patient discomfort from getting a cervix check and also reduce their infection risk from getting repeated cervix checks. And I have to wonder, if these become the norm and then the doctors basically never check the patients anymore, if that might take away something from their ability to clinically determine when our forceps indicated, for example, or what kind of forceps to use in those cases. But maybe then we'll have the odon assist device, so maybe that won't even be a question. I guess we'll just wait and see. But anyway we're almost out of time. I think there's one more thing we should try to mention in here, which is artificial womb technology, awt. I don't know if you can say ought, maybe just AWT. There's been a lot of progress on various approaches to artificial wombs in the last few years, and over the summer there was an application for a human trial to the FDA for this that's currently under consideration.
Howard:Yeah, well, we'll have to explain to listeners, I think, what this is for those who haven't heard of it before. But for many years now folks have been doing animal studies with what's being called an artificial womb, where a small preterm animal is attached to a machine through its umbilical cord and placed into an environment that simulates the intraamniotic life and allowed to grow as if it were in the womb. So this could be one of the most dramatic breakthroughs for preterm infants and potentially push what we consider to be a viable gestational age back, maybe by a few more weeks, and even for current preterm pregnancies that are delivered and resuscitated in the best case, maybe a 23, 22, 23, 24-weeker might just be allowed to grow for 16 more weeks in an artificial womb and maybe eliminate or dramatically reduce the complications that we currently have with particularly very early prematurity. That's the vision of this technology anyway.
Antonia:Yeah, so several research groups around the world have been working hard on this. The technology that's being applied for human studies in the US is called Extend, which is this abbreviation for extra uterine environment for neonatal development. This seems to be ahead of the other research groups throughout the world, and it's being studied at the Children's Hospital of Philadelphia, and it was created by a startup company called Vitara, or Vitara, and it's raised over 100 million in venture capital investments so far.
Howard:Yes, and I think we're going to see this come in one form or another.
Howard:The animal studies and this work has been very good In this company's case, these researchers, they want to study this. What they've applied for is to study an infant's born at less than 28 weeks gestation. Now, once the fetus is born, there's physiologic changes that occur almost immediately that make such devices impossible. So in order for this to work well, this process has to actually start before birth. So what happens practically is a C-section's done and before the baby's born there are tubes inserted into the umbilical vessels and after birth the fetus is immediately submerged into a bio bag, which is essentially the artificial womb, filled with an amniotic type fluid similar to the uterine environment. It's meant to mimic the exact circumstances of the uterine situation and then this is all hooked up to essentially an extra corporeal membrane oxygenation type system that provides the appropriate nutrition. It's a little bit more complicated than that, but provides the appropriate nutrition and oxygen levels and gas exchange etc to the fetus that hopefully doesn't realize it's been born, so that those physiologic adaptations don't occur.
Antonia:Well, in theory we know, or at least the research groups already know everything that is needed about recreating the extra amniotic environment, and so far in animal studies they've shown it to be very effective. Yeah.
Howard:So this went before the FDA six weeks or so ago I think, and they've so far they've paused on approving the human trial, but it was mainly about ethical issues. So over the spring there was a whole edition of ethics journal dedicated to potential ethical issues and implications of this technology. People are wondering what this means for the concept of viability, whether this is a fetus or an infant, since on the one hand it's not inside a pregnant person but it's also not adapted to extracurricular life. Tons of just ethical questions. I mean we could spend an hour talking about that addition and all of the sort of ethical things that come about from these ideas.
Howard:But all that's circulating around right now and so the FDA didn't approve it just yet because they want some more time to work out some of these ethical issues and legal issues for that matter. Does it get a social security number if it's outside of the mother's womb, or things like that? Does he get a birth date, or is the birth date when it just you can imagine? So they need to consider what consent looks like for the parents and what that would entail. So that's the only thing that's stopping us right now. All those things will be worked out. But if this does work, it could greatly reduce or eliminate the huge burdens of premature births in terms of disability and disease burden and things like that, and it might push back the gestational age at which pregnancies could potentially be salvaged.
Antonia:Yeah, that would be huge. So besides this artificial womb technology, there's also been talk about artificial placenta technology, and this actually dates back several decades. The idea, essentially, is to oxygenate the fetus that's been born extremely premature with ECMO-like technology and prevent attempts at respiration by leaving the lungs filled with fluid. But the difference is that with just an artificial placenta, the fetus isn't floating in a sack of fluid. They're outside of fluid, but it's just that their respiration is being managed as if they were still in utero. But researchers distinguish between these two technologies and it seems like the artificial womb technology, where they're in a sack, solves some of the problems that the artificial placenta cannot solve.
Howard:Well, one simple limitation of both of these technologies is the size of the umbilical artery and veins and what diameter of catheters exists that actually allow for sufficient flow. It's actually one of our limitations, even with small babies, is how small of an endotracheal tube or IVs can we put in these very small premature babies, and there's issues with like limits of laminar flow and stuff like that. So it seems like so far they can faithfully create catheters that are both small enough and have enough flow to replace the natural placental vessels for fetuses as early as 20 weeks. But there's a practical problem of what you do as the 20 or 22 week baby that you've cannulated, as it gets bigger over time and needs larger cannulas, and so all these sorts of things are the things that we have to work out for both of these types of technologies. But a hard limit to 20 or 21 weeks probably exists with this idea of the technology due to our inability, at least right now, to cannulate these smaller vessels and have any meaningful flow through those cannulas.
Antonia:Well, all kinds of exciting things to look out for. I think we're out of time talking about them, but we've spanned prenatal to post postnatal care I guess you could say postnatal. I'm sure that when I have grandkids that are going to their OBGYN appointments, I'll ask them something about I don't know, group B, strep swabs or whatever, and they'll just roll their eyes or have no idea what I'm talking about. So we'll just have to do our best to try to keep up with the changes until we retire.
Howard:I think you'll still be practicing when you're a grandmother, don't worry. You'll know about the GBS vaccine.
Antonia:Okay, maybe. Well, the thinking about OBGYN website will have links to the studies and videos and things we talked about today and look out for us in a couple weeks again.
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