Thinking About Ob/Gyn
A fresh and evidence-based perspective of all things related to obstetrics and gynecology. Follow us on Instagram @thinkingaboutobgyn or visit thinkingaboutobgyn.com for show notes and more.
Thinking About Ob/Gyn
Episode 9.4 Barbs, Birth Control Risks, Maternal Cancers, Aspirin, and More!
This episode dives into the debate surrounding the efficacy and cost of barbed sutures in surgical practice, questioning whether their time-saving advantages are justified compared to traditional techniques, especially for uterine closure. Additionally, it explores the implications of non-invasive prenatal testing for cancer detection and recent maternal mortality statistics, while advocating for evidence-based practices in both surgical and obstetric care.
• Analysis of barbed suture use and cost implications
• Discussion of unexpected cancer detection via NIPS
• Exploration of maternal mortality statistics and misconceptions
• The relative value of baby (a discussion of the perverse economics of pediatric and obstetric care)
• Summary of recent findings on aspirin dosages for preeclampsia
• Examination of venous thromboembolism risks with hormonal contraceptives
00:00:01 Barbed Suture in OBGYN Surgery
00:09:13 Comparing Surgical Sutures
00:17:11 NIPS Results and Maternal Cancer Detection
00:24:04 Maternal Mortality Trends and Data Analysis
00:38:50 Medical Reimbursements and Healthcare Priorities
00:47:20 Risk Factors in Birth Control Thromboembolism
00:54:37 Birth Control and Thromboembolism Risk
Follow us on Instagram @thinkingaboutobgyn.
Welcome to Thinking About OBGYN. Today's episode features Antonia Roberts and Howard Harrell discussing several new articles.
Speaker 2:Howard.
Speaker 3:Antonia.
Speaker 2:What are we thinking about on today's episode?
Speaker 3:Well, we're going to have a smorgasbord of some new articles.
Speaker 2:Great.
Speaker 3:A flight if you will. That's the beer term, isn't?
Speaker 2:it yeah.
Speaker 3:But first, what's the thing we do without evidence?
Speaker 2:Okay, well, I've been thinking about different applications of barbed suture. As you might remember, I went and did some continuing education last year, basically on how to not have to rely on barbed suture in laparoscopy, so basically how to comfortably tie knots and never have to bring out the V-lock or stratifex. But then, even since then, I still cave in fairly often and I use the barb suture anyway, even though I know how to not do that. I'm not in a brave enough mood right now to criticize that closing the vaginal cuff of a laparoscopic hysterectomy with barbed suture, even though I do want to get away from that eventually and I'm working on that. But on the topic of barbed suture, I was a bit surprised to learn that people are also using barbed suture for closing the uterus in a cesarean, which is of open surgery, of course. So I'm going to bring that up as a thing we do without evidence, even though I don't think either of us personally have ever even thought about doing that.
Speaker 3:Yeah Well, self-critique is an important skill, but I don't know that I would criticize barb suture in laparoscopy particularly. There's a large learning curve there and if it does save you several, several minutes, saves the patient several minutes of time, the cost difference perhaps justifies that, so you can have a North Star that the goal is to be able to do it without it. But there's, as I always say, surgical skills are on a bell-shaped curve and we do use enabling technologies. That's what the ligature is, or energy sealing devices are for vaginal hysterectomy perhaps. So I think it's good to get quick with tying knots laparoscopically, but if you save 10 minutes, let's say, by using a barb suture to close the cuff, then you probably should do that.
Speaker 2:Yeah, and that probably is what I do save. And really it shouldn't take 10 whole minutes to tie a knot, even laparoscopically, because the mechanics are very easy. But I run into issues with picking the right suture length and sometimes underestimating and then getting to the end and having too little to tie with, which is not the funnest thing to troubleshoot. So that's something I'm still refining and of course my OR team says hey, what about this barbed suture next time? So yeah, I've just been saving time that way. But at that continuing education course I did learn that if you use a thicker braided suture, like a number one Vicryl, which is thicker than the typical O-Vicryl, that's almost the same as using barbed suture because it won't slip back as easily. So that's a little pearl for you.
Speaker 3:Well, I pretty much close cuffs from below vaginally, not laparoscopically, so I don't have a ton of advice for folks about how to cut the optimal suture length before you start your repair. I guess I would say to practice these skills in a lab with all the extra time that you have and our listeners have, but that is the kind of thing that aids itself to dry lab practice and things like that. But in any case I'm OK with with folks doing that. But I'm also totally on board with questioning the role of barb suture for cesarean hysterotomy closure. Now we previously talked about using Stratafix for closing the fascia at the time of cesarean back in episode 6.2, and some of the same objections come up.
Speaker 3:It's an open incision, right, but people are using the absorbable Stratifix sutures for the actual hysterotomy repair and the main selling points are decreased operative time, which is considered valuable because time equals money. But there are some small manufacturer funded studies that talk about it saving a minute or so, a couple of minutes tops, which I guess is from not tying two knots, one at each end and some bizarre claims from studies about less need for secondary sutures due to bleeding and things like that. But of course that's a problem with small studies, particularly company funded studies. They're not really large enough or appropriately controlled to address some of these things, and so these could be false positive discoveries.
Speaker 2:So the question remains here whether or not saving a minute or even two is worth spending the extra money for the barbed suture, because we think probably saving eight minutes, 10 minutes or more really is a good thing in the OR and besides money, it can make a big difference in terms of freeing up the OR and the team in case the next emergency suddenly happens, and there's also eventually going to be some effect on patient risk of complications and also the whole surgical team's level of fatigue If they're spending 10 more minutes than they need to spend in there. But of course the cost is what the reps and stuff will talk about a lot. I searched just on Google how long does one minute of OR time cost, and I found an article from the Journal of Orthopedic Business. This was a group in Texas Paper came out in 2022, and they concluded one minute in the OR costs $46, which that I don't know. That might seem like a lot. I'm not sure how universal that is and maybe in some places it's even more, but let's say it's $40, $45. And the standard barbed suture product let's say that's about $40, $45 more than what we typically use Ficrol.
Speaker 2:The reps probably would say if you save at least a minute, it justifies paying for that.
Speaker 2:But that isn't entirely accurate because OR time typically is billed in larger blocks of time, not by the minute, not by the second.
Speaker 2:So if you save a minute or two, that would really only matter in the rare case where that one extra minute pushes the whole procedure into the next billing block.
Speaker 2:I don't offhand know how block time billing would or wouldn't apply to a dedicated L&D OR. We have I don't think you have that, but we have that and that's not meant to be fully booked from nine to five or whatever every day. Obviously we want that to be open and available as often as possible for emergencies, deal with the emergency as quickly as possible and get out. But as far as the cost per minute, I'm not sure how it applies there. And then of course, with the suture costs, it's always hard to tell how much do these actually cost, just if you search on the internet. Fac facilities often are going to have their own supply contracts with different companies and that might not be easily accessible knowledge. But the price per barbed suture is likely at least going to be 20 bucks more, probably more like 40, 50 bucks more a piece than the cost of Vicryl or Chromic or whatever we might typically use.
Speaker 3:Yeah Well, the OR time that's a good point Like probably the minimum block. The time comes in is in 15 minute chunks, and so if you're unless you're rolling over into the next chunk these arguments about cost per minute probably don't matter. And the cost per minute that a hospital might bill isn't necessarily what they're getting reimbursed. They may just get the same amount regardless. They do, regardless of how long it takes, but then they view that as a cost to non-use of the facility. So there's a lot in there, and so don't be distracted, I think, by product reps that tell you hey, you're saving X amount of time, but I'm not even sure you're saving that amount of time. So I'd push back on that.
Speaker 3:Even to claim that it saves a whole minute to skip tying a knot in this open case, I think might be a stretch. I can't imagine that, frankly, tying two knots should take an experienced surgeon more than about 10 seconds. If you really are saving significant amounts of time with barbed suture versus a regular suture over knot tying, then there's probably lots of other things we could talk about working on that might save you a lot of time in the operating room besides this. So we've discussed before about overutilization of cautery, for example, as just a huge drain on time, particularly cesarean. But we have to not rely on these small manufacturer-funded studies, or even meta-analyses of small manufacturer-funded studies, to answer this question, and so, in fact, I'll put a link to the largest data set that we have, which shows that the only real, statistically significant difference between the barb suture group and the traditional suture group was that the barb suture group actually took a couple of minutes longer.
Speaker 2:Isn't that interesting? Yeah, and so that study did show less ileus in the barb suture group, even though they took a few minutes longer. But that outcome appears to be an outlier for what's really a relatively rare complication after cesarean. They probably weren't powered for that, especially since this was a retrospective study and not an RCT, right?
Speaker 3:Yeah, it was a retrospective study but it did include over 3,000 patients and it was the same surgeons at the same facility, single institution, who switched from traditional suture to barb suture over a period of time, and they just did a sort of a before and after comparison.
Speaker 3:The barb suture is coming second and they got slower is what they found. So one of the things that I talk and write a lot about is understanding levels of evidence and that one good study, for example, can trump many bad, smaller studies. But even a well-done retrospective study like this is often better than many of the small, underpowered prospective company-funded studies. I'll put a link to a typical study that the company may throw on your desk when they come and visit you, and this study just had 100 patients. It was funded by the manufacturer and of course it showed they saved a few seconds. But to consider that manufacturer-funded study with just 100 patients superior to an independent study with over 3,000 patients that use the same population of patients and the same surgeons at the same facility demonstrates a flawed understanding of evidence-based reasoning. If you will.
Speaker 3:But even if you're allowing for saving a few seconds from tying knots, it's still just hard to justify that at an expense of 50 extra dollars or so.
Speaker 2:I'm really curious how it made them slower, because there's really shouldn't be any learning curve. You're just actually omitting a very quick step. But anyway.
Speaker 3:Yeah, but that shows what happens in lots of these studies where people are making a big deal out of just it's a different population and it's a little different.
Speaker 3:Maybe the thing that made them slower was different routines in the OR, and maybe the thing that made them faster by a similar amount in other studies was the same thing, and so that's the problem is assuming causality from these sorts of things. The point is it probably doesn't matter and you don't even need the study to do this. You can take a stopwatch and you can time somebody using a traditional suture 10 times and you can time somebody using a barb suture 10 times, and I'll accept that that's the difference. Whatever time difference you get in that average, you do it for yourself.
Speaker 2:And, to be clear, none of these studies say that there's any difference in blood loss or any other important clinical outcomes. So really it is just about the time.
Speaker 3:Yes and again preying on people's idea that we have this novel thing. And of course companies they develop and they bring on new product lines the same company selling these in the traditional sutures we use. Only you come out with a new product and it's novel and you convince people to use it and feel novel and you make a lot more money Even for the traditional sutures that we use. That's another area where there's a lot of variation in practice. A lot of us old fogies like me I'm calling myself old will use chromic on the hysterotomy, but a lot of younger whippersnappers like you will use vicryl and there's a lot of folks who use monocryl and genuinely believe that it's superior.
Speaker 2:And with that too, studies really don't show a difference in outcomes between those three that you just mentioned, Even though some people might say, theoretically monocryl gives a thicker scar or has less serosal trauma, less adhesions. I've heard that argument, but none of it has actually been shown to translate into detectable clinical outcomes in real life practice.
Speaker 3:And while there might be some subtle difference between how these three traditional sutures perform, but the truth is, you know, we haven't even. We have had a struggle to answer with numerous trials one layer versus two and all that stuff and so most studies are just underpowered to detect significant distinctions. And if you see that over and over again, where we've never really seen a difference, it's because there isn't one. There's probably not a difference if you use the barb suture either. I'll put a link to a recent typical randomized trial that compared monofilament to multifilament sutures and the total enrollment in that trial was only about 300. So you just aren't going to see significant differences, even if one subtly existed without thousands and thousands of patients. So I'd say that there's probably no difference between any of them.
Speaker 3:And then for me, the final analysis. It's really just about cost, and again your absolute prices for these sutures will vary. You can try to figure out what they cost at your hospitals, but typically Chromic is cheaper than Vicryl and Vicryl is cheaper than Monocryl, and all three are way cheaper than a barb suture.
Speaker 2:Yeah, that's a fair consideration. I think a lot of maybe younger trainees I don't really think I'm that young anymore, but I have maybe a gray hair coming in but while I was trained on Vicryl, some arguments there are that it's a little easier to work with because it's not so stiff and it doesn't turn into a noodle when it's wet and it's less likely to break than chromic. So that's very helpful, especially when you're training someone and then, once you get used to the mechanics of Vicrol and then you try to switch to chromic, you probably really are going to break a few stitches. I think chromic is nice.
Speaker 2:Yeah, I'm not used to that with chromic, but you I know you don't have to tie as many knots, so maybe that saves a little time too.
Speaker 3:There you go.
Speaker 2:Yeah Well, for at least the first half of my training I thought vikril was it. I didn't even think that there were any other options for this. I thought everyone always does vikril right. But then I've I've seen chromic in action for cesareans and I've seen Monacryl, and they all seem fine and they're all done by great surgeons and they all have their own convincing rationales.
Speaker 3:So yeah, and a difference of $2 or $3 per suture is not really a heel worth dying on, so do what you're comfortable with. But a $50 difference for barbed suture, that's going to add up quickly for a hospital. If a hospital does 1,000 cesareans, that's $50,000. And of course the price only goes up if you use more than one suture. Some people use two sutures, either due to some imbrication or two-layer closure or whatever, or even just coming from both sides. And now you, your hospital with a thousand cesareans, has spent a hundred thousand dollars on excess suture costs. They didn't need to.
Speaker 2:Well, since we picked on this, on this thing that not we do, but some people do If you're someone out there that uses barbed suture to close up the uterus after a C-section, I maybe would challenge you to have someone time you when you're tying a knot and then just ask yourself is it really worth losing that much money on a barbed suture rather than maybe just learning a way to tie a little bit faster? And if there's any listeners out there that this actually applies to, let us know your thoughts, because I don't think I personally know anyone that does this that I could just casually ask them. And I think if I asked my L&D department, if I requested I want barbed sutures now for my C-sections, I think they'd raise their eyebrows at me.
Speaker 3:Yeah, I'll say this and we can talk about it some other time. We have a lot to get to, but if you want to save a minute at closing the hysterotomy compared to what you're currently doing, follow yourself and don't let your assistant follow your suture. So for residents who are training, learn to follow yourself and you'll save a lot of time. We can talk about that later.
Speaker 2:Nice.
Speaker 3:There's lots of ways of saving time and so if people are really interested we discussed before in doing the 10 to 15 minutes cesarean routinely. There's a lot of things that go into that. Barb's suture just isn't one of them.
Speaker 2:All right. Well, let's move on then and talk about our Sforges board of articles. There was one about unexpected cancer detection via NIPT testing in pregnancy. So when patients do the cell-free DNA testing for fetal aneuploidy, there's an expected ratio of maternal versus fetal genetic material that's all circulating in that maternal blood sample and these tests can differentiate that. Usually it's about 90% maternal and 10% fetal DNA, which that's mind-blowing to me. Already, at 10 or 11 weeks, 10 fetal dna fraction, but sometimes rarely if, especially if the mom has a cancer she doesn't know about, there's going to be an unexpected amount of genetic material found that doesn't belong to either either one. It's not the typical maternal genes or the fetal genes. It it's tumor genes, because these tumors have usually genetically mutated to become cancerous and they're also putting out DNA fragments into her circulation too. So that's going to mess this test up in a little bit different way. So in this kind of a case you might get a report that says fetal status not reportable.
Speaker 3:Right, I've never seen one of these, and I guess you haven't either. It's pretty rare.
Speaker 2:Right. Thankfully I have not had this yet.
Speaker 3:Well, they're definitely occurring out there, especially as this sort of testing now is becoming almost universal, I think, in prenatal care. Now, this would be a different result from insufficient salarity. That just means that there wasn't a large enough fetal fraction for the company to process the test, whatever their threshold is.
Speaker 2:I've seen that plenty of times.
Speaker 3:You get that a lot.
Speaker 2:Yeah.
Speaker 3:And you just repeat that test in a week or two, and then you get a valid result.
Speaker 2:Yeah, so the study we're referring to here was in the New England Journal of Medicine in December 2024, and they were evaluating the prenatal cell-free DNA testing and its role in detecting maternal cancers.
Speaker 3:Right. So they had 107 patients who fit this description and then what they did was to try to find the cancers was. They did whole body MRIs Talk about getting insurance approval and to detect what cancers they might have and they found cancer in 52 of the patients about half of the patients. They also commented that physical exams and laboratory tests were essentially of no value in identifying these cancers. They needed the MRI. The most sensitive cell-free DNA finding was when patients had a combination of copy number gains and losses across multiple chromosomes, and for patients like that, 96% of the patients had cancer, whereas patients who only had losses or gains only, but not both, they were likely to have a non-malignant condition like, say, a fibroid.
Speaker 2:That's interesting. So obviously one of the first things we're getting is this result is not going to tell you this type of cancer. The genes can't be traced to a certain type of cancer, at least not yet.
Speaker 2:Yeah, not yet, and I think we've both had plenty of patients with fibroids in pregnancy who still had normal NIPT, so it's not like that's super likely to cause this kind of a result. But in this paper, of the 52 patients who had cancer detected, 32 had a hematologic cancer and then the other 20 had a solid organ tumor. Two had a hematologic cancer and then the other 20 had a solid organ tumor. And then of the rest of the patients who didn't have cancer, the most common thing identifiable ended up being a uterine fibroid, and who knows if that was actually incidental, whether that actually caused the result or not. Some others were determined to have a placental mosaicism and that was based on doing a biopsy of the placenta after delivery. But most of them were just false positives no pathology at all, no cancer, and just remained unexplained.
Speaker 3:Right, and don't be falsely reassured by the fibroid. They actually specify that if you find a fibroid, that doesn't mean you found everything, and so three patients in the group had both cancer and a fibroid. So don't just put in your head that fibroid explains it.
Speaker 2:Yeah, because you'll see fibroid on an ultrasound. Don't just prematurely say we cracked the case here. A little more than half the patients with cancers were asymptomatic, but about a quarter of them had some abnormal symptoms that in retrospect probably were because of the cancer, but at the time they had just been attributed to that. This is a variant of normal pregnancy, like patient with pancreatic cancer had acid reflux, for example.
Speaker 3:Right. Well, if you download the supplement to this article you can get into specifically what these cancers were and I'm sure people are curious. The most common type was Hodgkin's lymphoma, followed by non-Hodgkin's lymphoma and then colorectal cancer and breast cancer, along with cholangiocarcinoma and then bringing up the rear. They had one case that was adrenocortical carcinoma, a Ewing sarcoma, a lung cancer, the pancreatic cancer you mentioned, and a renal cancer. But 20 of them had Hodgkin's lymphoma of the 52. And of course, you're able to see the enlarged lymph nodes associated with lymphomas on MRI. The other interesting thing was that the stage diagnosis which they discovered these cases again, many of whom were asymptomatic. There were several very advanced stage cancers. The pancreatic cancer, the Ewing sarcoma those were stage four, as well as the breast cancer, was stage four. In all the colorectal cancers there were nine of those. They were stage four. So these were young patients with advanced cancers and five of the asymptomatic, completely asymptomatic patients had stage four cancers.
Speaker 2:That's pretty wild and that's a lot of colon cancer. Not nine of them, it's a lot when you think about it. Anyway, the accompanying editorial was really good. It highlights the problem that we may not be able to get full body MRIs paid for at this point for patients with these kind of results, because it's not the purpose of the NIPT test and insurances may say we don't think this is a clinically valid thing you're asking for. But really that should definitely be reexamined.
Speaker 2:A full body MRI just makes sense for this kind of NIPT result, given the findings of this study and the failure of just history and physical labs to find where these tumors might be originating from. And of course MRI is preferable to CT scan in pregnancy. So unless there's an obvious symptom or finding that would lead to a more direct type of cancer diagnosis, it would be hard to justify not imaging patients with this kind of result. So this is going to be interesting. I think this opens a lot of new questions like does a normal NIPT definitely mean the mom doesn't have cancer? Or are there some cancers that still could give a normal NIPT, maybe the early stage ones or certain organ systems, and especially if someone has abnormal blood count or a breast mass or rectal bleeding. Even with what this study found, I think if they have a normal NIPT you probably still need to work them up and rule out cancer anyway.
Speaker 3:Right. Well, this is just the beginning and obviously these papers are coming out and we're going to see develop these sorts of testing for cancer specifically in the next few years. So stay tuned, but this sort of testing may become commonplace within the next decade in non-pregnant people looking for cancer. So okay, but yes, not meant to screen for maternal cancer. But if you get this result, this is what we should probably be doing.
Speaker 3:So, all right, let's go on. So last episode we had Jacqueline Vidalish on and we discussed advanced life support for obstetrics and obviously we keep coming back on our podcast to maternal mortality and controversies around that and we want to be clear about some of the narratives around maternal mortality and so maybe we could visit that again. Just briefly.
Speaker 2:Yeah, that was a really great episode, by the way, and hopefully that is something that none of us would have to manage. A maternal cardiac or respiratory arrest at least not on a regular basis, but hopefully ever knock on wood. But regardless, being fully prepared for it obviously makes a big difference in outcomes.
Speaker 3:Yeah Well, we're both practicing in Tennessee and the Tennessee Department of Health just released its newest report on maternal mortality in Tennessee, which goes back to the year 2022. It takes a little bit of time for this data to get reviewed and published, so these reports are available in every state now and they're all similar in terms of methodologies and definitions. They're not exact, but similar In almost every state. They're produced by some state-level maternal mortality review committee, as is ours in Tennessee, and they're very informative to look at in your own state, in your own setting, to understand a little better about what types of things we're seeing and what we're talking about with maternal mortality.
Speaker 2:Yeah, and we have talked about this at length before, but we know when our patients read about these headlines in the newspapers or online that say maternal mortality is on the rise. This is a big crisis, a lot of them are going to think about a woman bleeding to death or seizing on the delivery table and her heart stopping, and that's just a terrifying visual. And really in no state is eclampsia or hemorrhage a number one cause of maternal mortality. In no state. In the US, in some more than others, really, it's drug overdoses that typically happen sometime after the patient has been discharged home within the first year of giving birth and, sadly enough, suicides, homicides, car accidents all that occur outside of the hospital that are also adding to these numbers. So reading your individual state's report can help you get some perspective on the problem and also show you where we need to focus on from public health and legislative perspective to actually improve maternal mortality.
Speaker 3:Yeah, exactly. So I just want to highlight a few things from our newest report. The more strict definition is what's called pregnancy-related deaths, which are deaths that are deemed directly related to the pregnancy. In contrast to that is pregnancy-associated deaths, which are perhaps coincidental to having been pregnant or being pregnant. Maybe a car accident falls into that category. For example, a patient just happens to be six weeks pregnant, or maybe she's postpartum, but no other real connection. So I'm going to talk about pregnancy-related deaths so that's the stricter definition which have been declining after the spike we saw with COVID, where we had a high of 53 in 2021, and then that came down to 45 in 2022.
Speaker 2:Well, declining mortality is good.
Speaker 3:That's good. There's also a trend that doesn't look so good, though, and that the percentage of all deaths deemed as pregnancy-related, rather than pregnancy associated has been increasing. So some of this is due, in every state, to the composition of the committee that does the review, and then the definitions and the discussions around this that are used, and this has been happening everywhere. And so let's say, for example, a death related to a drug overdose, in the view of one committee, well, they might consider that pregnancy associated, but then the composition of the committee changes, and under the new composition, a new committee comes together and says no, we think this was pregnancy related. So the pregnancy related deaths have been declining overall, despite the fact that, as a percentage of total maternal deaths, the committee is deeming more of them pregnancy-related than it did in the past, rather than just pregnancy-associated.
Speaker 2:Okay. So maybe it looks like it's a bad trend, but it's actually. If you read between the lines, it may be actually a good trend. They're just expanding the pregnancy-related definitions. Well, yeah, that exact thing that you just explained. That accounts for a lot of the confusion, I think, about rising rates of maternal mortality, because there is some subjectivity involved in these determinations. Like you gave a story one time of a patient that died in a car accident on her way to and from an OB visit.
Speaker 2:Like I could see how that could be. Someone could argue that's pregnancy related and someone else could say it's not.
Speaker 3:Yeah, and that committee out West decided that was pregnancy related rather than associated because it was related to getting prenatal care.
Speaker 2:Yeah, that makes sense. Well, yeah, so, as you've said, committee compositions change. They're not like lifetime appointments. And even if the committee doesn't change changed, they're not like lifetime appointments. And even if the committee doesn't change, thought processes change a bit and the trend nationally has been to consider more maternal deaths to be pregnancy related and not less. But that still means that the total overall number of maternal deaths is still declining.
Speaker 3:Yeah, yeah. So there's some philosophy and subjectivity in there, and that's really important to remember when we start making international comparisons, because the US is definitely more aggressive, if you will, in considering deaths related to mental health or other issues as pregnancy related rather than associated, when we compare to other European and Asian countries. So remember, there were 45 total maternal deaths in Tennessee in 2022, which is a rate of 55 per 100,000. Now, that's for the whole year. So the other confusing thing is that the WHO and the CDC will report just the 42-day number, so it's going to be lower than that. But our bottom line, the stuff that we see in our papers, is the one-year data.
Speaker 3:Now, 15 of these were related to mental health conditions and the majority of those were directly related to substance use disorder. They were overdoses. Essentially, the trend in overdose death among pregnant women nearly matched the trend in overdose deaths in Tennessee among all Tennessee residents, so it's obviously a crisis. The rates had been slowly increasing for several years, but for this report, if anything, they've started to decline. Finally, a little bit. 11 of the deaths were due to infections, of which nine were COVID-19. So maybe the other two infection-related deaths had to do with sepsis relating to delivery or something like that, we don't know. 12 had a cardiovascular condition, and that number was about equally divided between cases of cardiomyopathy and preeclampsia in a category that they called other. Six were related to hemorrhage, three were related to thromboembolism, two were homicides and I think seven were attributed to other causes, which included stroke, amniotic fluid embolism, complications from anesthesia, kidney disease, diabetes and some other pulmonary hematologic condition.
Speaker 2:All right, I know that in that report they were focusing on how a lot of these still were considered preventable. So let's look at the timing of when these deaths occurred. Remember this statistic includes any time from the start of the pregnancy up to one year after delivery or after the end of the pregnancy. So five deaths happened on the day of delivery. Another six happened within the first week after not the day of, but within the first week. A total of 26 deaths happened sometime between the day of delivery and the first six weeks after, and then half of them were outside of the hospital.
Speaker 3:Right. So remember we had 45. So 26 of them met the timing definition that the WHO uses when talking about other countries. So that number gets smaller when we try to use similar definitions. But even among those there still may be an issue. So we have to keep all that in mind when we try to compare these numbers to other countries, which we often unfairly get compared to other countries without this thought process taking place, because they again don't include anything beyond six weeks.
Speaker 3:But also in many cases they wouldn't consider, even within six weeks, death due to COVID or substance abuse or suicide or things like that. They wouldn't consider those to be pregnancy related. So we have different definitions, different timelines and that makes these comparisons fraught with error and really we shouldn't do them. But the good news is the rate of death from direct obstetric events in Tennessee is low and comparable to the rate of death internationally in other developed countries and despite increasing the number of conditions that we consider pregnancy-related, we're still seeing a decline in those deaths, although frankly that's mostly due to the rebound from the COVID pandemic. But hopefully 2023 and 2024 due to the rebound from the COVID pandemic, but hopefully 2023 and 2024 numbers will be even better when they finally are published, and we'll talk about them when that happens.
Speaker 2:Yeah. So basically, we don't need to coast. We still need to keep working, but we also don't need to just give up and say it all sucks, we're just we're not doing anything right now. We're we're getting, we're making some gains, so we just need to keep working. So, yeah, we'll probably circle back to this another update on this in a year when the next numbers come out. So let's keep moving to some other articles. For now, there was a study in the gray journal in from 2025 that was originally re released as a pre proof in January on their website. This was a comparison of the two different aspirin doses for preventing preeclampsia in twin pregnancies, and this was a multicenter retrospective study with propensity score matching.
Speaker 3:Yes, and this, the thought, is, of course, twins. This is a very high risk patient population for the development of hypertension preeclampsia Again, not a randomized controlled trial. Many of the things that we deal with in pregnancy are not always amenable to prospective trials, but we've talked before about the really overwhelming lack of evidence that 81 milligrams of aspirin actually does prevent preeclampsia, maybe compared to higher doses, and this study maybe adds something to our knowledge base about that.
Speaker 2:Yeah, so here they included about 1,900 twin pregnancies. 75% of them, unfortunately, received no aspirin at all, but the rest of them that did were split equally between one or two baby aspirins, so 81 or 160 milligrams. They found that the lower dose did not decrease risk of preeclampsia, whereas the higher dose did decrease it by about 40%. And they noted no difference in other outcomes that you might worry about, especially low platelets or hemorrhage or anything like that.
Speaker 3:Yeah. So this is tough because this doesn't necessarily mean that we should start using double the dose, but it does at least add to the evidence that we've been wasting our time with 81 milligrams of aspirin and we don't have an affirmative recommendation, in this country at least, to use a higher dose. But aspirin, the 81 milligrams the indications have really creeped out. It's almost become its own little cult in obstetric clinics around the country, as we've discussed before. But there's simply no RTCs or no evidence that shows that it really does anything to reduce the risk of preeclampsia at that 81 milligram dose. So it's definitely time to at least discuss the higher dose and have quality trials that look at that and revisit this recommendation in the United States.
Speaker 2:It is interesting why we haven't used the higher dose regimen in the US as broadly as how it seems to be favored in Europe, right, at least based on all these studies coming out of Europe. So trials like this and some other European trials that we've looked at before make it seem like we really should be doubling the dose. If we think it's indicated then at all, then it should be the double dose. But really the truth is it's still an open question about whether the higher dose actually is safe or effective, and in fact there was a paper presented this month at the Society of Maternal Fetal Medicine that counters the idea that even that these higher doses would be valuable.
Speaker 3:Right, and we don't have this published yet so we can't really go into detail about it, but this was called the ASAP trial, a-s-a-p-p, and in this case they randomized patients to either one or two 81 milligram baby aspirins and they found no difference in the rate of preterm preeclampsia or preeclampsia with severe features between the patients who received the two different doses. These were, again, were a high risk patient population and should have been the sorts of patients that would most benefit from aspirin, and they again we haven't seen this published yet, but they didn't find a difference.
Speaker 2:Yeah, one problem with this trial that might mess with the results a little bit is they didn't start patients until they were 16 weeks along and in the European literature that's already shown that there's really not much benefit to aspirin if you started that late. Typically we'll recommend starting it at 12 weeks. So this still doesn't mean that the higher dose isn't effective, at least if you start it earlier. And if you started at 12 weeks that would be consistent with the conclusions of some of the European earlier. And you know, if you started at 12 weeks that would be consistent with the with the conclusions of some of the European studies.
Speaker 2:And it's also interesting when you get a study of two active agents and there's no difference, does it mean that they're both effective or that they're both ineffective? It would have been nice if they had also included a placebo arm, like zero aspirin, one baby or two baby aspirins, because the bias one way to interpret this SMFM study is they both had an impact. The 81 is just as good as 162 here, but since they both started at 16 weeks in this study, I bet it's actually that neither of them had an impact.
Speaker 3:Yeah, yeah, those are great points, and we do run the danger of this just being another quagmire, like tocolytics, where we start a practice that doesn't have a single randomized trial that shows benefit and then it's continued because we assume that it works. And then, of course, when you do a study, you can't have a placebo arm because it's standard of care and then you spend the next 20 years assuming that your baseline even worked. That's what happened with magnesium sulfate. I think we desperately need an appropriately controlled trial to answer the question of whether or not aspirin is beneficial at all and at what dose and at what gestational age. But again, just a reminder, we don't currently have a single trial I'm using the word single there with emphasis that says that aspirin at 81 milligrams prevents preeclampsia, even in these higher risk populations, and it's, of course, become widespread practice.
Speaker 3:Well, I do want to mention quickly for anyone who subscribes to the New England Journal of Medicine or has access to it at work, that there is a prospective piece in the January 25th 2025 edition by Rachel Fleischman called what is the Relative Value of a Baby, and this is really worth reading. It's an opinion piece. They publish some of these almost every edition We've talked so much about declining access to care and what we tend to prioritize in healthcare in different ways. Rachel has a very well-written piece, insightful piece, about the lack of prioritization of reimbursement for pregnant women and children and tells the story of 31 minutes that she spent saving a newborn's life. That was ultimately reimbursed at 1.94 relative value units or RVUs. And she talks about what the OB got for 14 visits and delivery and all that, which is also a relatively small number. And then, by contrast, she points out that 30 minutes of hair removal with electrolysis is reimbursed at a rate of 264 RVUs.
Speaker 2:Right. Yeah, that's quite an impactful comparison there and for anyone who doesn't know what an RVU is, just probably pause and Google it and come back, because we're not really going to be able to explain it that quickly. Basically, it's how medical services are priced out in the US and there's a lot that goes into it. But anyway, yeah, I read this. She mentions how these RVUs are, what numbers assigned to each procedure is determined by a small group of people behind closed doors, and she uses the word cartel to describe it, and it's a little bit indignant in the tone in this article. But before any of our OBGYN or pediatric friends listening just want to throw their phone down and say I'm sick of this, I'm going to quit and change specialties.
Speaker 2:I looked up these numbers and I think that the author got this RVU number for the hair removal from a fee schedule list that was made by the US Department of Labor. It was last updated in 2021. That's not quite the same as the fee schedule paid out by Medicare or Medicaid. That comes out yearly and there's already a 2025 version that tells us what the government health care plans essentially will value different types of procedures and services. So, anyway, 264 RVUs for hair electrolysis procedure that takes 30 minutes.
Speaker 2:On that RVU list it's actually listed as not payable by Department of Labor, I'm assuming that means most. At least government insurances will not pay for that. So you can imagine, generally that kind of thing is going to be more elective and cosmetic and more likely to be out of pocket for the patient, whereas obviously saving a baby who can't breathe is not elective and it's going to be covered of course. And we know there's plenty of other frivolous things out there that cost way more money than a life saving medical procedure costs. Take a submarine tour to the bottom of the ocean for $25,000, or something like that. So in some ways the cost isn't so much about how important it is as much as it is how expensive was the equipment and also how much is a rich customer willing to pay.
Speaker 2:So at least we know that in as she was discussing in this article, the hair electrolysis is not directly robbing the labor and delivery units from the same pot of money. It's not like they're just paying for the dermatologist's yacht in their fifth vacation of the year while we're all just toiling away on call. But this RVU list from the Department of Labor was really interesting to just scroll down and look at what number is assigned to what procedure, and some of them are surprising. So again, if you consider, her reimbursement for saving the baby was 1.9 RVUs. There was a procedure called excise excessive tissue from the buttocks that is valued at 12 RVUs. There's a I guess this is more of a device, but heat lamp without a stand is valued at 90 rvus. There was a lot of lab tests on there that, like the drug screen for cannabis, somehow was listed at 120 rvus. Still trying to figure out how that actually works in practice probably mass spectrogram.
Speaker 2:Yeah, three seconds mass spectrography yeah, so the technology that's involved and then brain MRIs are over 3000 RVUs. I didn't know that. And then, of course, I wanted to scroll and see what is the very highest number I can find for a covered procedure that's payable. And what I found was over 70,000 RVUs for a retinal prosthesis, and that's about 10 times more than a heart transplant. And of course, just because it says it's covered doesn't mean insurance is going to green light it, no matter what. There's probably some fights there. And then on the low end, I was also surprised to see before people start saying it's all old white men that are making these lists treatment of penis lesion was only assigned 1.1 RVUs, but then a male urinal jug, like they use inpatient, was three RVUs and then a urine pregnancy test was eight RVUs.
Speaker 3:Yeah, seems like almost everything. Even the male urinal jug was more valuable, though, than saving a baby's life for 31 minutes. There are some apples to orange comparisons there. We don't know how these work out in practical terms. They're covering some of the cost of the equipment and stuff or the technology associated with it, obviously, but I did for her RVU total for 31 minutes of resuscitation for a newborn. For the average Medicaid rate across the country, that comes out to about $55 in terms of what's reimbursed per RVU, and so there's two issues.
Speaker 3:It's what we allocate this time to be worth, but it's also that because most pregnant women and children are covered by the Medicaid program, and Medicaid, just by who it enrolls, has a larger percentage of children and pregnant women than other categories and it pays the least. The net effect of all of that is we have a system that just doesn't value children and pregnant women, and we see the effects of that in labor and delivery units closing and pregnant women and children losing access to care.
Speaker 2:And there was also plenty of things on the list that are listed even though they're also assigned to zero RVUs. So you wonder why is that even listed at all? But that includes even things like taking a patient history or giving education. So I'd really encourage people, if you haven't done this before, look up a list of RVUs and just skim it and judge for yourself. Does this seem fair?
Speaker 2:And, as you said, it's undeniable that the healthcare system and the insurance companies, at least in the US, and the state and federal governments in the US are not prioritizing the care of children and pregnant women, because I know they don't have unlimited money, but at the RVU levels and reimbursement levels they've set, the birthing units in the country are being shut down. People are not going into those specialties and going into those communities to practice and, as a result, the babies and their families are being deprived of very basic and essential care. And just going back to some of the numbers, I found it doesn't make sense that the reimbursement for full OB care, including all the prenatal visits, delivery, postpartum care I think she said that's about 36 RVUs. How is that less than the value of one single drug test or one single heat lamp?
Speaker 3:Yeah, well, does that include the cost for the lamp too? I think some of that stuff also shows the influence of technology and industry. It's why we talk about being cost conscious. If you want to improve your labor and delivery units, bottom line, your hospital stability, then when you use VLOC or a robot to do things, you don't need that stuff, for you're helping those companies make money that comes from a limited pool of money.
Speaker 2:Yeah, it's just so easy to get carried away with this, but you take 10 male urinal jugs and that's the same cost as all of OB care.
Speaker 3:You're really on fire about this.
Speaker 2:Yeah, yeah. So it really would be nice to maybe shift some money from less urgent things, like urinal jugs, for example, more to OB and newborn care. I know it's probably a tangled web and it's not just that straightforward, but it's clear that some shifts from somewhere have to be made and can be made. So just have a look at this baby RVU article and get inspired. Don't get jaded. You can get angry, but get inspired. Share it with people and become outspoken, become politically active about this problem, because it is a political problem.
Speaker 3:It is and do share it. I actually was lobbying at our Capitol and shared this with some of our elected officials and I've emailed it to them. This kind of stuff works for that, so email this to your state senator or representative with a note about priorities. So, okay, there was a fairly important research letter in the February 10th 2025 edition of JAMA that looked at the risk of venous thromboembolism with various methods of hormonal contraception. This also has been shared a lot in the last few days on social media and in the news, and so we should probably talk about that for a couple of minutes.
Speaker 2:Yeah, so this was a Danish study that used their national registers and we talk about these sorts of papers a lot.
Speaker 2:They are typically uncontrolled retrospective trials, but they correlated patients with a DVT or pulmonary embolism diagnosis with their histories of having been prescribed some method of birth control. And there's already a lot of potential problems you can see with this type of study. So we don't know if the patients actually consumed those birth control methods. We only know that they were prescribed and it's also pretty hard to control for differences in comorbidities. So it could be that patients who had higher risk of thromboembolism were prescribed methods that we think would give them lesser risk and then, as a result, their underlying risk factors would give them still a higher outcome of having a higher rate of the thromboembolism. And that might surprise you if you're not accounting for their underlying status. So in other words, they didn't adjust for every possible underlying risk factor here either. So before we even talk about the results, just know that there's always limitations to studies like this. But overall they had a lot of data. They had over 5 million person years of use and nearly 1,100 VTE events.
Speaker 3:Yeah Well, and great analysis of the problem with these sorts of studies and using large databases like this, which is just, it seems, a paper a week out of Northern Europe, because they have these socialized health systems that have these great databases, so it's easy to mine them for studies like that and at the same time it's hard to get real life numbers for a relatively rare event like this. So we need to do these sorts of studies, but it does have problems and they did try to control for what they could. But the point is that charts aren't always complete and just don't know that.
Speaker 3:So they included oral contraceptive pills with 20 micrograms of ethanol, estradiol, and also those with a 30 to 40 microgram dose, and then they also tried to break it down by different types of progestogens. In those pills there's also the vaginal ring and the patch, as well as oral progestin-only contraception and the three hormonal IEDs, as well as the implant and Depo-Provera. They did try to exclude patients who were noted to have had risk factors for thromboembolism, such as cancer or a genetic thrombophilia, and they even excluded polycystic ovary syndrome in patients with liver disease and a few other things. So they did make an effort, but it's also easy to understand that these charts are often not complete and so the data is not there.
Speaker 2:You can't control for it, yeah also easy to understand that these charts are often not complete and so the data is not there. You can't control for it. Yeah, if you know someone even documents in a different section of the note, then, typical, they may not have captured it. You can imagine how easily that could happen. And it's also easy, with rare events like blood clots, to have significantly different outcomes, even when you exclude or control for things like that, because, again, the computerized document system is not perfect. So there's so many other risk factors you could still come up with that were not accounted for, like smoking status, age, bmi, how far postpartum may be, all that kind of stuff.
Speaker 3:Right. Well, let's talk about the results. They saw two venous thromboembolisms per 10,000 person years for the patients who are non-users in their control group. So 2.0 per 10,000 will be our comparison to baseline. Now they report 8.0 events for users of combined OCPs, but this includes all doses of estrogens and all types of progestogens.
Speaker 3:When you look at the individual pill types, there doesn't seem to be a significant difference between 20-microgram pills and the 30 to 40-microgram pills. I would assume that most of those in that range are 35-microgram pills. But if you look at the particular 20 microgram pill like they have as a category a 20 microgram pill containing levonorgestrel the rate there was 5.0. So that sort of pill is typical for the generics of a less that we have in this country, like lacina and latera. If we compare that to the same levonorgestrel, the same progestogen, if we compare that to the same levonorgesterol, the same progestogen, but in the 30 to 40 microgram ethanol estradiol range, then the rate was 7.6 compared to 5 for the lower estrogen. So I imagine that corresponds to a pill like Nordette in this country.
Speaker 2:Yeah, yeah, nordette has 30 micrograms of the estradiol, so it seems like it shows that the lower dose of estrogen is associated with at least a slightly lower risk of thromboembolism, but still increased from baseline, of course. And they didn't have the 10 microgram in this study, so you can only make guesses on that. So we have the low, low estrin here. They also listed pills with desogestrel and drosperinone. They also listed pills with desogestrel and drosperinone, the two different progestin types and in both categories of estrogen dosing. And they also had gestodine, which I'm not sure that we have that in the US, but for all of those within, if you take one type of progestin and it has a lower or a higher dose of estrogen, there was a similar difference or there was always a consistent decrease slight decrease in the VTE rate when it's lower versus higher estrogen dose. So I think we already knew that lower estrogen means lower risk of thromboembolism and their findings were consistent with that.
Speaker 3:Okay, yeah, and my go-to inexpensive generic pill is the generics of Aless, like I said, lacina or Latera, with the 20 micrograms of ethanol, estradiol and levonorgestrel. So that has a rate of 5.0 per 10,000, which is actually the lowest of any of the pill types that they include in the study. Now, again, they didn't have the loloestrin. It's also, in this country at least, the cheapest of those 20-microgram pills, so that's my go-to.
Speaker 2:It's still higher risk than the baseline 2 per 10,000.
Speaker 3:Right, Absolutely Right. Okay, Well, they have the patch. So for the patch it was 8.1 per 10,000. And for the vaginal ring it was 8.0 per 10,000.
Speaker 2:So those rates are a little bit higher than at least the less generics. But remember, the overall rate for OCPs was 8.0. So both the patch. We're also told that the vaginal ring delivers a lower dose, but in practice it looks like it still confers the same rate of thromboembolism as the orals. Overall you might be able to do a little bit better by using the lower estrogen pill, but you're not going to reduce the thromboembolism risk by using the vaginal ring. And just on the flip side, our friend wanted us to note that if you take the Yaz, the drosperinone pill which is typically used for people with PCOS, that in the US has a much higher rate of 13.6 VTE per 10,000 person years and that was seen in some data before a few years ago.
Speaker 3:There's a lawsuit over it, in fact, and one of the hard problems a few years ago was, well, was this pill being preferentially given to patients with PCOS, and maybe that's why you see that higher rate Now. They excluded patients with PCOS, but again, pcos is very common. Maybe people are thinking this patient's on that spectrum and I'm going to preferentially use that pill. So that's why you need randomized controlled trials to provide a definitive answer for that, ok. Well, maybe now some more surprising results for listeners. The rate of thromboembolism for the progestin only pills was 3.7 to 4.3. And the rate for Depo-Provera was 11.9 per 10,000.
Speaker 2:Yeah, that is surprising and you know that the progestin-only pills is a low dose. It's I believe-. Like 0.35 milligrams of North Endrone and no estrogen, obviously. Right and we. They didn't look at this in this study, but we typically will prescribe five milligrams of progestin for heavy bleeding in older women and people that probably have more DVT risk too.
Speaker 3:And there's a drosperinone progestin-only pill being marketed in the US. And implicit in the marketing both for that pill and for NuvaRing, which has something like 11 micrograms of daily ethinoestradiol absorption, and for gestin-only pills in general and for Depo-Provera is that this is the stuff you should use in patients who are at increased risk of thromboembolism, and that's clearly not the case.
Speaker 2:Yeah, we have it in our heads that the reason women get DVTs on birth control is because of the estrogen, and so many women who have contraindications to estrogen, including a higher risk of DVT, are going to be prescribed these progestin-only medications for that reason.
Speaker 2:But this study is not the first to find an increased association. It's been known for a while that progesterone and progestins are associated with VTE risk and it's a dose-dependent result even without any estrogen, just the progestin-only. So, as I mentioned earlier, this could be because of the patient's underlying risk factors, maybe the higher risk patients preferentially were given Depo-Provera or progestin-only pills. But in theory the authors at least controlled for those highest risk people and took them out of the equation like they weren't giving Depo to cancer patients. But we do have to change the narrative that progesterone only does not increase the risk, because in fact Depo-Provera had the highest risk of any birth control in this study and that's been given very liberally to patients in the past, especially immediately postpartum, like on the postpartum ward, or patients with other type of VTE risk factors.
Speaker 3:Yeah, just had a cesarean and get your depo before you go home.
Speaker 2:Yeah.
Speaker 3:Right, yeah, there are also claims that among the different types of progestogens there could be a different risk and in this study the so-called third generation progestogens they actually had the highest risk. So what we're told by drug reps and marketers doesn't always bear out. There are claims that estradiol meaning bioidentical estradiol, instead of the ethanol estradiol typically in birth control pills in the US, might not be associated with the increased risk because it's bioidentical. It's the same argument made by purveyors of hormone replacement therapy that somehow it's the version of estrogen that's making the difference. But in fact they did include a pill with bioidentical estradiol and it had the exact same risk as the 20 micrograms of ethanol estradiol. So a lot of people will switch to new pills.
Speaker 3:We're seeing that in this country now, where we have a novel estrogen pill, that a lot of it's very expensive, that people are switching to because of some theoretic advantage. But this real world study shows that this is largely nonsense. Companies what they do is they conduct studies and they'll find a rate in their study of thromboembolism in a population that they have selected carefully and that rate will look lower than what's been reported in other studies in different populations or for different products. And then they'll try to sell it on that. But you have to have a head-to-head comparator trial to actually know and you can see from a study like this. You need a ton of patients to see a statistically significant difference in the rates, which is the benefit of studies like this that have millions of patient years exposure in it.
Speaker 2:If the bioidentical argument was true, then that would mean in pregnancy having that natural estrogen you wouldn't have an increased risk, but you do so, yeah, well, the good news is we haven't gotten to their findings yet on the hormone IUDs, and the total rate of DVTs for them in this study was 2.1, which was not statistically significant from the baseline of 2.0. And this could even be in spite of the fact that these were probably preferred in patients with higher risk of DVT. So I think we can confidently say that hormone IUDs are the way to go if you're not trying to increase risk of DVT or PE in patients, which are really the major causes of any kind of severe injury or death due to birth control.
Speaker 3:Not all of these DVTs were confirmed, so they broke down the data by confirmed thromboembolic events versus reported thromboembolic events and the associations remained. It didn't matter which group of those two groups you looked at. Of course the numbers were slightly different, but it didn't matter when they excluded the non-confirmed events. So, yeah, maybe some questions about the reliability of the data that we talked about, just by the nature of the way the study was done, but this does seem to be among the best data we've ever seen, looking at the forms of birth control and current use. And the big takeaway for a lot of folks will be that they should not assume that systemic progestogens, birth control, mini pills or Depo-Provera and things like that don't increase the patient's risk of thromboembolism, because they do, and Depo-Provera in particular substantially does.
Speaker 2:Oh, and let's also mention the arm implant. We didn't mention that. That had a rate of 3.4 per 10,000 person years. So essentially similar to the oral mini pill and better than the other combined methods, much better than Depo-Provera, but still not as good as the IUD, still more than baseline. And I thought it was interesting here they had that lower dose hormone IUDs had rates of less than 2.0, almost as if that protected someone from getting a DVT. Do you have any thoughts about that?
Speaker 3:Well, I have to think that the non-use rate that they have calculated probably included a lot of people who weren't good candidates for birth control.
Speaker 3:That's maybe why they were non-users.
Speaker 3:So perhaps, again, just a weakness in the way this data was collected, the nature of the design If someone who has a family history of thromboembolism a very strong family history that might not be in their chart, but the doctor's sitting there thinking, I'm not sure I want to put you on birth control at all with that family history, so let's do something different.
Speaker 3:And so the non-use rate likely includes patients who have significant identifiable risks that just weren't charted. So maybe, though, in the IED subgroups, you're really getting, especially with the lower dose ones, that's going to be a population of younger women, nulagravid, 20 years old, probably not obese like some of the very lowest risk in terms of age and everything else. So they get the small implant, the small IEDs for their form factor, and so you're probably just seeing that the rate of thromboembolism at baseline for those populations is 1.3 or 1.4 or something, and it doesn't have it in there. But birth control pills, overall, consistently increase the risk of thromboembolism by about fourfold, depending on which one you use and Depo-Provera by about five to sixfold. Apparently, is the takeaway, and IEDs do not.
Speaker 2:Well, so now let's ask the question how liberal should we be with dispensing prescribing birth control pills? And what's the argument for or against those over-the-counter mini pills? Because weren't they supposed to avoid that risk of blood clot and avoid the need for medical screening? The progesterone-only pills in this study were almost as bad as some of those lower dose combined pills with estrogen.
Speaker 3:I think the bottom line has always been that you are at an increased risk of thromboembolism and morbidity and mortality if you become pregnant a very significant risk even compared, really, to the worst of these methods. So you're safer still with Depo-Provera's risk than the risk conferred upon you by pregnancy, and so that's always been the idea is that if you're trying to avoid pregnancy, you're reducing morbidity and mortality. But it's still our job to advocate for the lowest risk methods of birth control and most effective, which are, and continue to be, the hormonal IEDs. That should be the gold standard, and that's one of the negatives I think of. Over the counter, progestin-only birth control is that we don't have an opportunity for patients who might be getting those to adequately screen these patients and counsel them about the best methods with the lowest risk, and so they end up getting a method that does increase the risk of thromboembolism and just isn't very effective, and we lose out our opportunity to educate them.
Speaker 2:All right. Well, before we close out, we should point out that this same exact group published data about some other outcomes from the same data set. They looked at stroke and myocardial infarction according to birth control method and this came out in the British Medical Journal in January 2025. It looks like they decided to get two whole papers out of the same data. Essentially, they also looked at 22 million person years of use and in that one the eye rates and ischemic stroke rates were their outcome of interest.
Speaker 2:The rates for stroke in non-users was 18 per 100,000 year use, because it's more rare. It was 39 per 100,000 in the combined oral contraceptive groups, 33 for mini pill and 23 for IUD users, so still higher than 18, but not by much. The rate of heart attack, essentially per 100,000 person years of use, was nine at baseline. So non-users rate of nine per 100,000 compared to 18 for combined OCPs, 13 for mini pill and 11 for IUD, and, after they made some adjustments, only the IUDs were associated with no risk or no increased risk of stroke or MI, and there was also an increased risk of those outcomes for the Nexplanon and the patch. So it's like the exact same trends, just more rare events.
Speaker 3:Yeah, and for the progestin-only pills there was increased risk. So yeah. So doses matter. Progestogens increase your risk of clots and stroke and heart attack, and to minimize risk and maximize efficacy and patient satisfaction, patients should preferentially be getting IUDs.
Speaker 2:All right, well, I think that does it for today, so I'll wrap it up for this time. That's my job now, okay, well, you want to wrap it up? Go for it. Yeah, go for it.
Speaker 3:Well, we'll make some little infographics with these rates and put them on the Instagram. I think that'll be good to show the numbers, and then we'll be back in a couple of weeks and you'll be back in a month.
Speaker 2:Yeah, I'll be back in a month.
Speaker 3:Yeah, and we'll see you then.
Speaker 2:All right, sounds good.
Speaker 1:Thanks for listening. Be sure to check out thinkingaboutobgyncom for more information and be sure to follow us on Instagram. We'll be back in two weeks.