Episode 8.13 Flagyl, GBS, DUTCH, Jada, Quickening and More!
Challenge preconceived notions in obstetrics and gynecology with our latest episode, where we dismantle myths that have long influenced medical practices, even in the absence of scientific backing. From unraveling the misunderstood reaction between alcohol and metronidazole to examining the overlooked risks of clindamycin cream, we’ll look at how these misconceptions take root in medical culture. We continue with a critical analysis of intrapartum GBS prophylaxis, correcting widespread misunderstandings around its purpose and timing during labor and how it affects labor management.
We address the rise of dubious hormone tests, like the DUTCH Test, marketed to consumers, painting a cautionary picture of how social media amplifies these unvalidated products. We highlight the importance of consulting healthcare professionals while discussing the potential paradigm shift that self-collected HPV testing could bring to cervical screening, as recommended in the coming cervical cancer screening guiudelines. This new approach might revolutionize screening rates and quality of care, especially for underserved populations, all while realigning healthcare providers’ focus on more pressing medical needs.
Prepare for an engaging conclusion as we scrutinize the comparative effectiveness of postpartum hemorrhage devices Jada and Bakri, emphasizing the ethical implications of cost versus efficacy. We’ll take you on a historical journey through the concept of “quickening” in pregnancy, reflecting on its cultural significance and evolution with modern science.
Plus, changes for next season!
00:00:02 Metronidazole and Alcohol
00:13:03 Intrapartum GBS Prophylaxis Guidelines Clarified
00:24:54 Hormone Testing and Cervical Screening
00:31:07HPV Self-Collect Screening Implications
00:42:54 Comparative Efficacy of Postpartum Hemorrhage Devices
00:51:29 Historical Perspectives on Fetal Development
Links Discussed
ACOG Committee Opinion: Prevention of GBS EOB
Draft Recommendation Statement: Cervical Cancer Screening
Transcript
Announcer: 0:02
This is Thinking About OB-GYN with your hosts Antonia Roberts and Howard Herrell.
Antonia: 0:17
Howard.
Howard: 0:19
Antonia.
Antonia: 0:20
What are we thinking about on today’s episode?
Howard: 0:22
We’ve got a few articles and some updates to discuss and some exciting news about changes coming to the world’s number one OB-GYN podcast next season. We’ll get to that at the end, but first what’s the thing we do without evidence?
Antonia: 0:35
How about telling folks not to consume alcohol when they’re prescribed metronidazole?
Howard: 0:41
Okay, yeah, this is a great one, and I’m as guilty of this as any person, I’m sure. So tell us more.
Antonia: 0:47
It’s pretty straightforward. I only actually recently became aware of this myself, but this is coming straight from the CDC, so I’ll just read it straight out. A review regarding alcohol consumption during metronidazole treatment reported no in vitro studies, animal models, reports of adverse effects or clinical studies providing convincing evidence of a disulfiram-like interaction between alcohol and metronidazole. And just as a sidebar, this is exactly what I was taught in med school and it had just carried over for the longest time, so I’ll continue reading.
Antonia: 1:21
The previous warning against simultaneous use of alcohol and metronidazole was based on laboratory experiments and individual case histories in which the reported reactions were equally likely to have been caused by alcohol alone or by adverse effects of metronidazole alone. Metronidazole does not inhibit acetaldehyde dehydrogenase, as occurs with disulfiram. So this was like first year med school stuff. Yeah, ethanol alone or ethanol independent side effects of metronidazole might explain the suspicion of disulfiram-like effects. Thus, refraining from alcohol use while taking metronidazole or tenidazole, which is similar drug class, is unnecessary. And then here’s a bonus factoid from that same excerpt Clindamycin cream, which is another thing we would use to treat some of the similar conditions, is oil-based and might weaken latex condoms and diaphragms for up to five days after use.
Howard: 2:21
All right, I guess that’s a mic drop then.
Antonia: 2:23
Yeah, it’s just the thing that people do without evidence.
Howard: 2:28
And a lot of people will use the clindamycin gel just so they can have alcohol to avoid the metronidazole, and then they, incidentally, might be increasing the risk of pregnancy or STD if they’re using condoms for STI prevention so of course, we’ve been collecting all these things we do without evidence, and the truth is there’s just a ton of them, and I love how these things become permanent in our minds.
Howard: 2:50
Both of us were doing this like two weeks ago, right, I mean this is, if any of my patients are listening and I told you this two weeks ago, I just learned too right. So we’ve been talking recently about how just the culture in medicine and in different circles and where you practice and where you train, from one institution to another, one city, one town to the next how much that influences what we do. But if you think about the concept of evidence-based medicine, there shouldn’t be variation based on culture. We should all agree on what the evidence says and even where there’s not, say perfect evidence, we would have some consensus of opinion about what the best evidence is and then we would all practice basically the same way.
Antonia: 3:31
Yeah, but we don’t exactly live in that world, because we live in a human world and we’re all humans with unique ideas and philosophies, motivations and fears and biases. And then it’s a power struggle thing sometimes, where one person wants to just assert that I think I’m right about this and I want everyone else to do it my way, and then so it just becomes the way it’s done in one little corner of the world. So this little segment that we’re doing is our way of highlighting just how much of what we do, or what a lot of our colleagues do, is potentially born just out of bias or something else other than scientific evidence.
Howard: 4:15
Yeah, just tradition and inertia and thought inertia.
Howard: 4:19
I’m fascinated with how incorrect factoids and information becomes institutionalized in our culture and in our own individual brains. So I was definitely, as you were, taught this metronidazole thing in med school and I can’t tell you how many times I’ve warned patients about consuming alcohol during a couple days before and a couple days after while they take their Flagyl and various other treatments. Like we said, like clindamycin, have become popular and promoted by companies and just so you could have a tool to use or a therapy to use when someone might not want to avoid alcohol to avoid harm. So I think this is a rather easy one where we can all just say today that we’re going to stop saying that to patients, but I’ll bet you that some listeners will still say it out of habit or out of an abundance of caution. Even the theoretic possibility and of course the real problem is most of us out there practicing you and I included just haven’t been told that this information was false. There’s so much to know and so much to update, and so we didn’t even know.
Antonia: 5:20
So you mean, not everyone out there listens to this podcast yet or thoroughly reads every CDC update.
Howard: 5:26
There’s a few stragglers. Yeah, it’s just easier to do what you’ve always done. I mean, that’s one thing we’ve definitely learned over the last few years of this podcast.
Antonia: 5:33
Since this is our last segment for this year, for this season, do you have a bonus one? I know we still have a long list, so maybe one more thing we do without evidence.
Howard: 5:44
Yeah, I don’t think we’ve talked about this one before, at least not in detail. But how about avoiding breaking water or amniotomy when a patient’s GBS positive until after she’s completed the first dose of the antibiotic or the penicillin for at least four hour period?
Antonia: 6:01
Yeah, that’s another example of something that’s definitely variable according to really culture just the local culture where some places really don’t care at all and other places will treat this as a hard and fast rule. And so, whichever way you learned how to go on this question, depending on where you work or who trained you you’re likely going to continue to carry on that practice and treat it as a given and then subsequently pass that on to your own colleagues and nurses and et cetera. And whichever answer you currently believe to this question, you probably can make a rational argument for it or at least give a theory of why you’re right. So if you do wait for four hours after the first GBS antibiotic dose before you break water, it may make sense to you that getting that antibiotic adequately on board before the baby is exposed to GBS is a good thing, that it would theoretically protect the baby somehow or at least prevent you from winding up with a precipitous delivery before the four hours is up. So what is the evidence on this say?
Howard: 7:15
The answer, I think, is just right in ACOG Committee Opinion 797, which says that interventions including starting oxytocin or artificial rupture of membranes or a planned cesarean, say, for somebody who has ruptured membranes or even anything like that, shouldn’t need not be delayed just to give the four hours of antibiotic administration before birth.
Antonia: 7:39
Okay, so just another mic drop, but we’re done with this.
Howard: 7:42
Maybe I mean these microphones were using their expenses, so let’s not drop them, but maybe I do think it’s a little bit more complicated. And even that ACOG committee opinion it seems like it hedges. It says that you might consider delaying or, if the delivery is indicated, don’t delay these things just because you’re worried about the four hours and all that. So I think we have to think about this just a little bit more. That is the name of the podcast.
Howard: 8:06
So, that ACOG committee statement. The concern first of all is not about having some pre-specified amount of time where antibiotics are on board before you rupture membranes after you’ve given the antibiotic, but rather the question is always will the patient have a vaginal delivery before the four-hour window, within the four hours of that dose administration? Because that’s the only metric that we’re really affecting, it’s whether there’s been four hours since the first dose until you deliver. So this statement in the committee opinion is saying that if someone comes in and they’re seven centimeters or something, and you hang the first dose and you think that breaking her water will make her deliver, say in two hours, so that you’re probably not going to have four hours of completed antibiotic administration, but maybe if you don’t break her water maybe she might stay pregnant for four hours, then you don’t necessarily need to change your management just for the goal of prolonging the pregnancy to get to that magic four-hour mark. But also you can consider letting her not breaking her water if there’s no urgency in getting her delivered.
Howard: 9:10
So there could be more to that picture and if you do that you might save the newborn some additional workup or length of stay. So the statement couches those words a little bit and, frankly, a lot of times I will do this. If I think that the difference between completing the first dose of the antibiotic before delivery is me breaking water or not breaking it, or augmenting with oxytocin or something like that and there’s no urgency, then yeah, there’s no reason in my mind not to wait. But on the other hand, if the patient would benefit from earlier delivery, go ahead and do it. And, more to the point, if it’s an induction and you have no concern about amniotomy is going to make you deliver sooner than four hours, you don’t need to avoid it just because she’s GBS positive.
Antonia: 9:53
Right. So, if for nothing else, we know that a healthy baby that’s delivered less than four hours after that antibiotic dose will likely still have different pediatric management just based on that timestamp and not necessarily for any other reason. But I think there’s also. I think there’s this concern that just having the fetus, like the fetal head and scalp, exposed to the vaginal flora without the protection of the intact membrane, is somehow going to allow more bacteria to just crawl up into the uterus and infect the baby before birth. I think that’s the theory here, yeah.
Howard: 10:36
And like. So. One of the risk factors, of course, for treating a GBS unknown person at term is if they’ve had prolonged rupture membranes for 18 hours, and that may confuse the issue too. We do know that that is a risk factor for GBS colonization. Now the thing is, though that’s a risk factor because it’s unusual. It implies that you have pre-labor rupture of membranes, and when you have pre-labor rupture of membranes to have been ruptured that long, it implies that there’s been a pathogen that’s associated with quarry decidual inflammation, and oftentimes it is group B. So if you just look at it statistically, that is a risk factor for group B colonization for a person who’s unknown, and therefore treat them as if they were group B strep positive. But on the other hand, if you had a group B strep negative patient who did have prolonged rupture like, say, you’re inducing her and you did break her water early on and the 19th hour clicks around and she’s just now eight centimeters, you don’t start antibiotics for that.
Howard: 11:28
It’s not that the length of exposure to the ruptured membranes is the risk factor. It’s the fact that you had inflammation leading to pre-labor rupture of membranes that’s the risk factor. So we’re not trying to protect them. And in the same way and we can talk about this more in a second but in the same way we don’t cleanse the vagina with betadine or anything like that. We know that that doesn’t work.
Antonia: 11:52
Yeah. So if someone out there does practice this, where let’s say here’s an example a nulliparous patient is coming in to be induced and she maybe she already had cervical ripening, or she just comes in at three centimeters and you could break her water, it’s incredibly unlikely that she is going to deliver in the next four hours if you break her water right now at three centimeters, even if you do that and start oxytocin. But there’s people out there that might say let’s not even touch her until it’s been four hours since her antibiotic dose because they’re afraid that, like we were just talking about, the longer that water is broken, the more the bacteria is just going to spread and run rampant inside the uterus and increase the baby’s chance of GBS sepsis.
Howard: 12:42
Yeah, and I think that this gets at the basic understanding of why we even do GBS chemoprophylaxis or how it even works. So sometimes we don’t we talked about this last episode we don’t talk about the most basic things that we just expect interns to know or whatever, and then we may construct narrative fallacies in our minds when we don’t understand some basic concepts. So what I’m getting at is what do folks think the antibiotic is doing? Do they believe that it’s cleansing the patient’s vagina of all group B strep before the baby comes into contact with it and therefore leave the membranes intact? Cleanse the vagina before you break the water so that there’s no exposure? And I think that people think that on some level.
Howard: 13:25
There was a survey in I can’t remember exactly 2004, 2005, of a few hundred physicians, a lot of whom are maternal fetal medicine physicians, and they basically asked what do they do when they swab a patient in the office? A screen and then the group B strep culture report comes back. That’s positive and they get that on their desk. And what do they do with that? And what they found was that about half of these doctors, most of whom are maternal fetal medicine doctors, would go ahead and send in a prescription for an oral antibiotic, amoxicillin or something, as if they had discovered a vaginal infection that they needed to treat, or a UTI or something that they needed to treat and cure with an antibiotic. But 36 weeks they just didn’t understand this. What back then was a newly implemented guideline of, and what the point of, intrapartum chemoprophylaxis was, because it wasn’t to treat an infection or clean the vagina.
Antonia: 14:19
Yeah, because by that logic we would also be using chlorhexidine or betadine or some other kind of vaginal prep or douching or something during labor to further try to reduce the incidence of early GBS sepsis. But those interventions do not change the risks at all. So that argues against the theory and that’s why we don’t do it. And neither does giving a course of oral antibiotics to patients who are GBS positive before labor. Really, the only exception to that is if it’s a UTI and it’s over 100,000 colony-forming units of GBS. But you still would treat them in labor. That’s just to treat a UTI and it’s over 100,000 colony forming units of GPS.
Howard: 14:55
But you still would treat them in labor. That’s just to treat the UTI.
Antonia: 14:57
Right, exactly to prevent pyelonephritis.
Howard: 15:00
Right.
Antonia: 15:00
And the committee opinion also points out that also getting intramuscular antibiotics doesn’t work either for this risk reduction. But it’s not about cleaning out the vagina of this bacteria. That’s just not going to happen. For almost all women who have it it’s not a pathologic infection and they don’t have any symptoms. It’s part of their normal baseline rectovaginal flora. It’s not an infection.
Howard: 15:28
Exactly so. The purpose of the antibiotic is to use the mother’s bloodstream and the placenta as a delivery system to the fetus and then eventually the neonate, to get on board a therapeutic level of this antibiotic that can then help the fetus tackle this infectious pathogen, if and when it’s encountered. About getting a full dose in over that four-hour time period was just based upon the pharmacokinetics of penicillin and how long it would take in theory to achieve a therapeutic level of the antibiotic. The truth is, a lot of information after the CDC study came out said that even two hours is probably enough to have a therapeutic level. But our guidelines were built around the four-hour dosing interval and of course it could be a different antibiotic anyway. It could be vanc or anseth that have different intervals but it’s about achieving a therapeutic blood level in the neonate.
Antonia: 16:19
Yeah, and again, the exposure happens during a vaginal birth, like kind of contact with the rectovaginal area, not the moment you break the water. You don’t have to get that therapeutic level just to break the water, because that’s not really the main point of exposure. And again, if the point was to cleanse the vagina before the baby passes through, then you would just stop after the one dose or maybe two doses, because then you would have killed it by that logic and you wouldn’t keep giving it every four hours until delivery and maintain the therapeutic antibiotic dose because that one or two doses should have been enough to cleanse it. Logic, and you wouldn’t keep giving it every four hours until delivery and maintain the therapeutic antibiotic dose because that one or two doses should have been enough to cleanse it. It’s not like there’s a continued, there’s not like a continued source of it.
Howard: 17:03
But again, if you were cleansing the vagina, it would be cleansed.
Antonia: 17:07
Yeah, yeah.
Howard: 17:08
Yet some women get one or two doses and some women get many more doses. Now I will say, if you have patients getting five or six doses, you’ve probably started the antibiotic at an inopportune time. We could get into that literature sometime. There are some studies that try to predict, like how many centimeters or at what time. Like you don’t need to start it when you’re one centimeter and using misoprostol, you should wait until you get closer to delivery so you’re not giving excessive doses of the antibiotic. But yes, it’s not like hey, it takes two doses to clean the vagina and then quit because it’s not about cleaning the vagina. So appreciate how many sort of narrative fallacies will come up if you assume that the purpose is to clean the vagina rather than to maintain a therapeutic antibiotic level in the newborn, including this one about avoiding rupture of membranes before full four hours of antibiotic half-life has been completed, especially in the context where you believe that the patient is going to be pregnant for a lot longer than four hours, as in inductions. Now there’s an interesting article that was done. It was a group of clinicians who had a similar thought and they decided to survey in their own large institution how the new GBS practices had changed and they published this several years ago in the American Journal of Perinatology. There was a lot of stuff like this in the 2000s, within a few years of the 2002 CDC guideline. So they just sent a survey and they asked their docs. They had 70 of their 96 docs completed the survey, or clinicians, I think included midwives, but basically 22.9% of them said that they their labor was progressing fast enough that they thought they were going to deliver in less than four hours or delaying or avoiding artificial rupture membranes. And they say that clinicians are altering their management. The vast majority of their clinicians had altered their management of labor in an attempt to achieve four hours of intrapartum prophylaxis. Their clinicians had altered their management of labor in an attempt to achieve four hours of intrapartum prophylaxis and they note that the 2002 guidelines do not specifically recommend prolonging labor and that these guidelines, even 20 years ago, were being interpreted differently in the clinical setting than the authors of the CDC guidelines would have intended and the effects and consequences they say were unknown at the time.
Howard: 19:31
So I do think, like I said, it’s reasonable. If you can help your patient’s newborn, avoid excess observation by the pediatrician or blood work or whatever the pediatricians might do, then it’s reasonable to do that. But in the same way, okay, you’ve only got an hour and a half of antibiotic on board and she’s complete. Are you going to labor down for two hours or are you going to tocalize her so that she can have four hours of antibiotic? I mean, that’s the point is. That’s not what any of this was about. Yeah, or just have everybody for that matter. You have a gravida four para three and she’s GBS positive. Should you bring her in and induce her to make sure she gets it on board, Because you’re afraid if she shows up in spontaneous labor she’ll be seven centimeters and deliver an hour after getting to the hospital? No, you shouldn’t. That was never the intention.
Antonia: 20:20
The other area where I think you probably see variation in management of GBS is for a term patient who is GBS unknown. So let’s say they just got their swab yesterday and now they’re 37 and 1 in labor, or just they never got their swab. Per the guideline you’re only supposed to treat in that circumstance if either they’re preterm or there has been rupture of membranes more than 18 hours or a fever, or if the patient was known to be GBS positive in a previous pregnancy.
Howard: 20:55
Right, and that last one is relatively new and one of the smallest of the risk factors, but it’s been added in the last few years. Of course we also would treat if there had been a previous neonate who had invasive GBS disease or, as you mentioned earlier, a GBS positive urine culture during the pregnancy, and those last two we wouldn’t even do the screen right, that’s just a given that we’re going to treat you.
Antonia: 21:19
They’re positive, yeah.
Howard: 21:20
Right, but in a situation where a screen was appropriate they didn’t have those risk factors. But for some reason, as you said, not done. Yeah, you would only treat beyond 37 weeks, essentially for the 18 hours of rupture or a fever or GBS. Now that you just were culture positive in a previous pregnancy.
Antonia: 21:39
Yeah, and that’s always been, that’s how I was taught. We even had the little. There’s a CDC app for put in the patient characteristics and then either treat or don’t treat. But I suppose this guideline is guideline was made to begin with because many people out there would just prefer to treat. If there’s any doubt, the GVS unknown, their knee-jerk thing would be to treat because it maybe just feels like the safer thing to do.
Howard: 22:08
Right, it feels that way but it isn’t, and that’s why the guideline says what it says, and we could spend the rest of this episode and another one getting into the statistics that inform that thought process, especially in regards to term pregnancies. But the really brief version of it is simply that GBS is a relatively rare phenomenon and serious GBS disease is relatively rare in term infants compared to preterm infants. So if you have a patient who doesn’t have risk factors, you are actually doing more harm than good when you give the antibiotic.
Antonia: 22:41
Some other questions that do come up, sometimes related to this, are whether or not GBS positive patients should be allowed to have their membranes swept in the office, and there’s no reason not to do that, but I know at least some people will raise their eyebrows. We also have no evidence that being immersed in water during labor is bad if they’re GBS positive, and there’s no benefit to doing any fewer exams than you normally would than what are indicated. Of course, please don’t do more than what’s indicated, but you don’t need to avoid exams for fear of pushing more group B strep up into the uterus, onto the baby. And also there’s no reason not to use cervical Foley catheters even outpatient Foleys for that matter or intrauterine monitors, if they’re indicated.
Howard: 23:28
Yeah, all these sorts of concerns might arise if you’re really scared of doing something because the GBS in the vagina is viewed as this dangerous infection. It’s not, it’s just a colonization, but half the babies, roughly, who are born to GBS colonized women will acquire group B strep and for a very small percentage of them less than 1% at term at least that can become a serious infection and so we just help them out by preloading them with an antibiotic. Now, in preterm babies it’s a much higher number. 17 or 18 percent will acquire an infection, so they benefit even more. But in term babies it’s a relatively rare thing and we help them by giving them this antibiotic.
Antonia: 24:06
All right, let’s move on to some other stuff for at least a few minutes. So have you heard of the Dutch test?
Howard: 24:13
Yeah, unfortunately, I have heard of the Dutch test.
Antonia: 24:16
Yeah, I only recently learned of this. It’s not Dutch, as in being from the Netherlands.
Howard: 24:21
It’s unfortunately no.
Antonia: 24:22
No, it’s an acronym. It stands for dried urine test for comprehensive hormones, and it’s something patients can collect at home with a little urine sample kit that costs about $250. And they send it in and this company will do some kind of analysis and tell them you have these levels of these different hormone metabolites in your urine. That might include sex hormones, adrenal hormones, cortisol, melatonin. I think there’s even a more expensive version that tests for even more things and the company claims it’ll tell you all sorts of conclusions about this, like what’s your hormonal status right now, what’s your risk for hormone-dependent cancers and what’s your risk for other problems like libido or obesity or infertility or menstrual issues, pms, sleep disorders and all kinds of other things.
Howard: 25:23
Yeah, and they have a whole network of providers that recommend this, and then when you get your test result back, they’ll send you to your DUTCH provider, DUTCH certified provider or whatever, with your lab results and then they’ll recommend a bunch of just nonsense for you to do based upon these lab results, and it’s essentially a con game. I mean, am I wrong about that?
Antonia: 25:47
Yeah, and this kind of testing seems to be on the rise and I’ve seen it for all kinds of different specialties and organ systems too. There’s a bunch of like digestive ones as well, and it seems to be especially common in the functional medicine world. People want to be able to learn all the insights they can about their bodies with the most easy test possible like it. If, they’re being told you can just give a urine sample or a cheek swab or a little finger stick blood test and mail it in and we’ll tell you everything about you, then it’s very enticing. But really people are just being taken advantage of, be told we’re going to recommend an intervention and then a repeat test to see how these maybe dietary changes are affecting your hormone levels, and of course, none of it is scientific.
Howard: 26:47
Yeah there isn’t only just one company or methodology by which this sort of idea, this testing, is being offered.
Howard: 26:54
So more and more our patients are coming in and they’re asking about hormone testing or some testing like this or other things.
Howard: 27:01
They may even come in with the test results already done, because they purchased this online, they saw it on Instagram or Facebook or TikTok or whatever, and they have this information in front of them with these hormone test results and things like that, like that. But these sorts of tests, and this test in particular, has not been validated so that the urine levels of these metabolites do they accurately correspond to serum hormone levels, just as salivary hormone testing has not been validated in that way, and in general, we don’t have any validation that these metabolites mean anything, that, even if they do, correspond well to serum levels of the hormones, like what does it mean and this is a static level of these hormones taken at one cross-sectional time, out of context, at a random time point, and that doesn’t tell us anything really about the actual function of hormones that these hormones are mostly dynamic and change in response to what’s going on in your life in your menstrual cycle or things like that.
Howard: 28:03
They can change by the hour, by the day, or, certainly with sex hormones, in a cyclic manner for reproductive age women and beyond that. We don’t have any evidence that making certain dietary or other changes or taking a supplement that someone’s going to sell you or anything like that, is going to affect these hormones in a way that is consistently positive for your health. So if a company or a provider is using this sort of testing or this idea of balancing your hormones or supporting your hormone health or things like that, patients should probably steer away from it. These products are, unfortunately, being directly marketed to our patients because they’re not FDA tests that require a physician order, and so you’re going to hear more and more about things like this, or the Dutch test specifically.
Antonia: 28:48
Yeah, and you know how social media algorithms work. So just be aware, if you are especially Googling or searching different symptoms that you have and suddenly notice these tests, are these ads for these tests are popping up, then it’s the algorithm trying to target you and it’s be very suspicious because otherwise you’ll end up $250 poorer with no actual, real insights into your health, like it’s really the same value as reading a horoscope.
Howard: 29:19
Right and waste a lot of time perhaps going down pathways when what you should have done was just make an appointment with your doctor and go over your symptoms. Maybe you do need hormones, maybe you’re in menopause that’s great, but like we can, we don’t need you to pee in a cup for that. Yeah, okay, most OBGYNs have probably seen or heard this month about the invitation for public comments concerning the US Preventive Services Task Force new recommendations for cervical cancer screening guidelines that will be coming out next year, and so these guidelines are open for public commentary until January 13th 2025.
Antonia: 29:56
Yeah, and it’s interesting to see the different responses depending on where you hear about this. ACOG has invited commentary, but depending on what different email lists you’re on, you may either see general support for the recommendations and maybe just FYI this is happening, or you may also see all out panic and desperate pleas to provide as much negative comments as you can to the task force. So why don’t you summarize what are these new changes that will likely come out in 2025?
Howard: 30:29
These are things that we’ve generally been talking about already over the last couple of years, but the primary recommendation will be that women from 21 to 29 continue to get cervical cytology alone every three years so that’s different than the American Cancer Society’s recommendation but that women from 30 to 65 have either a clinician or patient-collected HPV-only primary screen every five years. So the current co-testing with cytology would become an alternative and not the preferred pathway for screening from 30 to 65.
Antonia: 31:07
All right, so right away, the alarm bells that are probably going off in people’s minds are that patients could self-collect HPV every five years, starting at age 30. And as long as that’s negative, they may never undergo another pap or pelvic exam ever again.
Howard: 31:25
Yeah, exactly. So in an age where we already are struggling to have clinicians follow the current pap smear guidelines that have been around for quite a while and which de-emphasize the need for yearly pelvic exams and only require a speculum exam at least every five years or so as long as your testing is normal, this essentially goes a step further and says that this could be a self-collected HPV test.
Antonia: 31:49
Yeah, and this is really amazing for patients and probably would increase the number of people who are willing to undergo the testing, and I truly hope that this is going to be an option for me, too, whenever I’m due for my next screening a couple years from now and this is coming from me I fully understand the significance of cervical cancer screening. Like I’ve seen cervical cancer, I’ve seen what it does, and I also have full, complete trust and comfort in my colleagues who would do an exam on me if it was needed. But even with that, I still don’t want to do that if I don’t have to. So how much more so is that hesitance true for the average person, who they might be even just a little bit uncomfortable in general in doctor’s offices, or maybe a lot uncomfortable and especially with having their genitals examined. So I think for those people especially, this is going to be great. But if you’re a gynecologist whose practice is financially dependent on women coming in just to get their PAPs done, then this might make your heart sink a little bit.
Howard: 32:58
Yeah. So those folks will post negative comments about this and we’ve already talked about this before and seen it and they’ll argue that this is just lazy and that women are going to die of cancer because they’re not getting speculum exams or we’re not going to be screening for vulvar or vaginal cancers or ovarian cancers, even though we already know that bimanual pelvic exams aren’t a screening test for ovarian cancer and that pelvic exams are not effective at screening for vulvar or vaginal cancers in asymptomatic patients. So if someone’s already still doing yearly pelvic exams and even yearly pap smears, which a ton of people are on their patients, then yeah, this is a dramatic change, but I don’t think it’s a dramatic change for someone who’s already following the current guidelines and perhaps only doing a speculum exam every five years to collect the co-testing.
Antonia: 33:50
Yeah, yeah. And not only would this help to increase the frequency of testing in, especially in underscreened populations, and to lower the cost of screening overall and make it more available and convenient, but importantly, it also helps to free up the OBGYN workforce to do more important care. For patients Like these, pap visits are sometimes just so meaningless because the patient walks in and says I’m totally fine, I have nothing to talk to you about, my primary did everything and I see it all documented. I just need the pap. It’s just, it’s silly. So we talk all the time about a physician shortage, but some of that may be exacerbated by a misuse of our workforce to these kind of less necessary visits. If an OBGYN’s practice is mainly doing pelvic and breast exams all day long, like we mentioned, then their skill set is not being deployed appropriately and they’re largely providing just unnecessary, ineffective care to their patients.
Howard: 34:54
Right. They should be using their training doing a lot of other more urgent and more necessary care. There are patients who currently don’t have access to high quality obstetric and gynecologic care because our workforce or at least a portion of it is so busy providing care that might be financially lucrative and easy, but it’s just not meaningful to our patients meaningful to our patients.
Antonia: 35:20
Yeah, and we’ve also already talked about all the other things that an annual preventative health exam should focus on and maybe they do even at the primary care offices if they get in with primary care but mental health, substance abuse, weight management, other screenings and there’s lots of other things that are very meaningful for care, but they take time that we just waste on unindicated PAPs. So things like this primary self-screening for HPV will help provide us with more time and opportunity to focus on things that are really meaningful for our patients, while also enhancing our ability to screen for cervical cancer. If they come back with an abnormal test, then they’ll definitely need to see us for whatever follow-up is recommended, and then we’ll capture more of the populations that may not be getting adequate screening right now. So I view this as a really good change.
Howard: 36:14
Yeah, but it will be a change that people will have a lot of angst about, but maybe not angst for the right reasons not valid reasons.
Antonia: 36:22
Yeah, the paradigm is shifting and HPV vaccination has had a very positive effect on this. There’s a research letter in JAMA, published November 27, 2024, that looks at cervical cancer mortality over almost a 30-year period, specifically in women under the age of 25. So PAP guidelines have progressively decreased screening recommendations for young women. They’ve moved away from starting PAP smears. Initially it was with the onset of sexual activity and then it was within three years after the initiation of sexual activity and then it was just start at age 21, regardless of when they had coitarchy. And at the same time it’s also moved to less frequent PAPs in those age groups and also less aggressive treatment and also less aggressive treatment.
Antonia: 37:16
We very rarely now would do leaps or cones on a 21-year-old, but it used to be very frequent, even on people under 21. And part of this has been due to the ability to add HPV testing for certain PAP abnormalities to re-stratify their risk. So then, if they have abnormal cells but then normal or negative HPV, then they need less intervention. Have abnormal cells but then normal or negative HPV, then they need less intervention. But, as we’ve been doing, fewer and fewer PAPs in this age group. This article tells us the impact of all of these guideline changes on the cervical cancer mortality.
Howard: 37:50
At least in women under 25. And it also tells us, interestingly, the total number of cervical cancer deaths for that age group in that 30-year time period, and it’s 398. Now that’s, I think, an important number to keep in mind, because my guess is people think it’s a much bigger number, both patients and providers. And I feel like I’ve never not met a gynecologist who defended doing yearly in pap smears and pap smears under 21, who didn’t tell me that they’d had five patients personally. So like we misuse the term cancer a lot, I think.
Howard: 38:23
But so for all the folks who’ve had so much heartburn about the perceived importance of cervical cancer screening in these younger patients in particular, in Europe they don’t start until 25. They don’t even screen until 25. But I think they don’t realize how rare cancer deaths are and cancer in general, for cervical cancer is in that age group. So that’s 398 total deaths out of tens of millions of women under the age of 25 who have been alive in the United States over the last 30 years. And it’s not that those deaths aren’t important, but it puts it on such a rare level that you realize that a general screening program for the whole population is almost always going to do more harm than good, and so we have to be very judicious about how we implement our screening programs to not cause more harm.
Antonia: 39:14
And it would be interesting to see a breakdown of how many of those were in people that were getting screened according to the guidelines, because a lot of the really the only deaths I’ve ever seen in my training have been people just didn’t get screening until they had their diagnosis.
Howard: 39:30
Which is why self-collected screening can actually make a difference.
Antonia: 39:33
Yeah, and back to this article. Just as importantly as the low number of deaths overall is the fact that they’ve, year by year, been decreasing over time by about 15%. So there were 55 deaths in young women from cervical cancer from 1992 to 1994. So 55, and then only 13 deaths from 2019 to 2021. And that’s after those progressive decreases in screening guidelines. So at the current rates, over the next 30 year time period we might expect maybe only 100 deaths, hopefully less Right. But that’s also at a time when the overall population is increasing and we’re still doing less cervical cancer screening than we used to.
Howard: 40:25
Right A hundred deaths over 30 years.
Antonia: 40:27
Yeah, yeah.
Howard: 40:28
And most of those deaths would be prevented, not by a screening program but by enhanced vaccination rates. We’ve done this in the United States. This in the United States. These are great numbers, despite having, honestly, a relatively low uptake, an unsatisfactory uptake of the HPV vaccine compared to other countries, specifically Australia, where they’ve done a great job and basically eradicated these deaths.
Antonia: 41:02
Right. So rather than complain about changing the screening guidelines, we should just use that same energy and effort to work on increasing public acceptance of the HPV vaccine. And this was really looking at the impact of the quadrivalent vaccine that came out first. These numbers are likely going to be even better with the current nine-valent vaccine, so it’s not unreasonable to predict that in 20 years from now we may have zero cervical cancer deaths in young women if we have higher uptake of the 9-valent HPV vaccine.
Howard: 41:31
Right, and of course, what’s impactful for those younger patients will also pay dividends over time as they age, and then you see a declining rate of cervical cancer and cervical cancer deaths in patients older than 25 as well. So I’ll put a link, in fact, to a paper that looked at some models over time with different scenarios about who gets vaccinated men, women, percentages, things like that with the Gardasil vaccine and predictions about how we basically could eliminate cervical cancer really on an international level, not just in the United States. It’s still a major problem in other countries, but it is an eradicable disease.
Antonia: 42:09
In the US the most recent numbers show 2.2 per 100,000 women per year for mortality from cervical cancer. That has been continuously declining year over year. So it was five per hundred thousand in the 1970s, so now it’s less than half of that. So more Gardasil and decreased barriers to access for screening and care for the most vulnerable populations, potentially by allowing them to be screened at home and non-invasively, will only continue, I think, to make this better.
Howard: 42:43
Yeah. So let’s fight the right fight here and embrace these changes and promote vaccines that are saving lives Not just from cervical cancer, by the way, I mean, there’s a bunch of cancers that are. Hpv related but, this vaccine is making an impact on?
Antonia: 42:57
Yeah, let’s do maybe one more news item before we wrap our season up. There’s an article coming out soon, in January 2025, green Journal that looks at the effectiveness of Jada versus Bakri for postpartum hemorrhage. We’ve talked about these devices before and what data is available, and we’ve seen a huge uptake in the use of Jada. Because it’s new, it’s heavily marketed. It may be overutilized at some places, but cost is still a significant issue.
Howard: 43:29
Right. And the Jada is again about a thousand dollars per device, while Bakri balloons, which have been around for quite a while now, they’re closer to 250. And now you see units who will stock both devices. But the device that’s novel and interesting to people is the Jada. It’s heavily marketed and so you see a lot of them being used and over time of course you see an expansion of use, maybe to patients who might not really need them or necessarily be the best candidates. So that’s great if you’re an investor or you’re the one selling the product, but not so hot if you’re trying to practice financially responsible and justice-oriented, justice-based medicine.
Howard: 44:08
So we’ve talked a bit before about how often should these products be used and at what point in your hemorrhage algorithm, and it’s hard to study, it’s hard to know. I think I’ve said on here before that I’ve never used either of these devices. In nearly 4,600 deliveries or so that I’ve done and never needed to, never regretted not using one. So I’m not saying that no one should be using them by any means, but I am saying that this is another one of those cultural issues where you might use a whole bunch in your training and see it used routinely and then you might meet somebody like me that has never used them, and the truth is somewhere in the middle, perhaps. So, anyway, if you’re the company selling Jada, you’d love for one or 2% of all delivering patients to have these items, these devices placed, and, of course, you’d love for Jada to be the one, rather than the mockery balloon. But what is this article going to tell us about the comparative efficacy of the two devices?
Antonia: 45:06
This was prospectively collected data from 65 facilities between August 2022 to February 2024. So they captured over 123,000 deliveries, and postpartum hemorrhage was diagnosed in just under 5% of them. They used a hemorrhage control device in 11% of the hemorrhages that occurred, so that equaled up to 666 total uses.
Howard: 45:37
Oh, wow.
Antonia: 45:37
And it was about half and half. 300 of them were Bakri and then 366 were Jada.
Howard: 45:44
Okay, so that means that they use one of these devices and that comes out to be roughly half a percent of all their deliveries and I’m okay with that. That makes sense to me. Just back of the envelope I can see half a percent of patients may be getting them. I just worry about creep and overutilization and that becoming two or 3% or half the hemorrhages 2 getting them. I just worry about creep and overutilization and that becoming two or 3% or half the hemorrhages 2%. Okay, but how did the two arms do?
Antonia: 46:07
Okay, they measured quantitative blood loss and need for blood transfusion or massive transfusion protocols and also the rate of device failure, meaning that they defined it as they used it and it didn’t stop the hemorrhage.
Howard: 46:24
And with those outcomes. They found no differences between the two devices. Yeah, okay. So I conclude from that result that if you’re going to use something, you should probably be using the Bakri balloon if and when you need it, or that Jada needs to lower the cost to something competitive with that of a Bakri balloon, but basically we need to use the least expensive, or the with that of a Bakri balloon, but basically we need to use the least expensive or the less expensive of these two products, since their outcomes are the same in this trial.
Howard: 46:48
Just to say it for the 100th time on this podcast, before you decide to use a new product, you need two placebo-controlled trials that show that it’s effective and safe. Then you need a comparator trial that says that it’s as good as, or hopefully better than, the current gold standard, and then you need a cost effectiveness study. Now, placebo-controlled trials are not always possible and in fact this is a great example of where. How would you do that? It would be unethical and difficult to construct a pragmatic study where you gave them a balloon versus nothing. But we do have here a comparator trial against what presumably would be the gold standard for a device in this category, and the comparator trial shows no advantage over the other product. And then, of course, the cost effectiveness study is simply an extrapolation of this data. If you use 666 Bris, you’ve spent $166,000. And if you use 666 Jadas, then you’ve spent $666,000. So, from a medical justice perspective, our ethical standards say that we should use the Bakri balloon until Jada lowers the price.
Antonia: 47:53
Yeah, I’ve used both of these devices sparingly, I’d say. I’ve just still worked in enough different facilities where different things were available, and that’s my feeling is they were about the same Both of them. It’s sometimes tricky to get them to stay, and that was especially if, like the patient’s coughing a lot or now their uterus is really starting to clamp down and the Bakri just gets pushed out, even if you pack it in place. So the problem we’ve encountered with the Jada is that it’s we weren’t able to just get one.
Antonia: 48:26
they make you buy like a whole pack of them, so it’s a big cost up front. But anyway, it’s Christmas day, I think, when this episode is going to be released, and I think we’ve been using the number 666 already a bit much talking about these Jadas, so I don’t want to give people the wrong idea.
Howard: 48:45
Okay, yeah, hey, it was their study right. Maybe that’s why they delayed it to January. All right, let’s move on then, I guess, yeah.
Antonia: 48:53
Hopefully not a lot of people actually listening to us right now on Christmas Day, but if you are, I guess Merry Christmas or Happy New Year. Were you able to dig up any fun Christmas historical tie-ins or trivia? Yeah?
Howard: 49:08
it’s a tough one. I think I got it over my skis promising Christmas stuff, so not really. Christmas Day is a relatively boring day in obstetrics, and actually we talked about this a long time ago when we talked about the seasonality of deliveries. But Christmas Day is actually the day on which the fewest number of babies are born on any day of the year. So certainly no one’s doing scheduled inductions or cesareans on Christmas Day, and I think most people try to avoid it anyway as a birthday for their kids. So that means a lot of folks will get electively delivered in the few days leading up to Christmas. So there’s just fewer people ready to pop on the Christmas day, and so it’s the rarest of all birthdays.
Antonia: 49:46
Yeah, it always seems like extra special when a baby just happens to be born on Christmas day, and I think there’s even the fewest triages on that day too, similar to maybe a few other holidays like Superbowl or Thanksgiving, because people on those days have a really high bar about when are they actually going to go to the hospital with threatened labor, things like that. And well, of course, the classic Christmas story itself revolves around a birth.
Howard: 50:16
Yeah, and there’s a lot of interesting things that have been written in books and articles over many years about various aspects of birth as depicted in the Bible, old and New Testament. Most of the stories are in the Old Testament it’s a bigger book but the New Testament stories of the birth of Jesus and of John the Baptist do involve a few things, some concepts, including something that we still see today in our OB documentation, sometimes in prenatal flow sheets, which is this idea of quickening.
Antonia: 50:46
Yeah, and I’m sure quickening wasn’t just invented in this old or no, yeah, this was already a very prevalent thing, but it’s the moment when a pregnant woman first starts to feel the baby’s movements. So for first time mothers this is usually around 20 weeks and for women who have had children before it may be sooner. But for the longest time this was included in dating criteria for pregnancies because it was assumed if it’s been 20 weeks since reported quickening you were very likely to be at term, and I guess the assumption was women would write it on a calendar or something. They’d know the exact date. That happened In the pre-ultrasound era. This was actually a very important data point, but it still has carried over as a relic. It’s built into the prenatal flow sheets that I use right now. It’s in the due date section. It’s a line that pretty much me and all my colleagues, I think, have immediately learned to overlook and just leave blank, so we don’t really even notice it, but it is there.
Howard: 51:50
Right. Yeah, I don’t think we document it as religiously as we once did. I mean, I certainly did when we had the paper charts and you had those ACOG flow sheets or generic versions of them, as you said. There was a line you’d write it in there.
Howard: 52:02
But anyway, back to the New Testament idea of quickening. So the mother of John the Baptist is recorded as in Luke, chapter one, verse 41 is when she fills the baby leap, presumably the first time, although I think that’s not clear and this. But this idea was talked about a lot in liturgies and in secondary literature. So quickening in that time period, in the first century across cultures, was felt to correspond to what people would call insolvent. So a baby was first fully formed when it had movement, and so it was presumed that there was a period of time before when the mother just couldn’t feel movement, where the fetus did not move and therefore was not fully formed and was therefore not fully human and did not have a soul. And this is not just an idea.
Howard: 52:51
In Judeo-Christianity, this goes back many centuries before the time of John the Baptist and Jesus in many different cultures. Quickening, or animation, or ensoulment, was a widespread belief in the ancient world and, really honestly, into very modern times, until, of course, we started to realize that fetuses moved well before mothers had a perception of it. And we knew that before ultrasound, for in cases where women might have cervical incompetence and they happen to rapidly deliver a living pregnancy at 17 weeks and the mother hadn’t felt it move, but then it moves for a few minutes after birth. So we had this idea in the 19th century, but ultrasound really has changed our cultural perception of it. Now, in the ancient world, this idea of ensoulment or the fully formed fetus starting at the moment of quickening, it wasn’t universal.
Howard: 53:43
Stoics believe that a living animal obtained its soul at birth, when it first contacted the air and took in its first breath, and the Greek idea of the soul and all that is related to breath and air too. So that’s what they believed. And Epicureans, on the opposite end of that, believed that the soul was granted at the time of conception. Thomas Aquinas wrote a lot about these concepts of ensoulment or adhomination and was very influential in both the Catholic and subsequent Protestant denominations and influential in the thoughts about abortion related to this. So for a time after Pope Gregory XIV, which has been a few hundred years, the Catholic Church limited excommunication for abortion only to abortions of what was called a formed fetus or a fetus that had received ensoulment, and that would roughly correspond in many people’s minds to when quickening was observed. So this has been a concept that’s had a lot of attention over many, many, many centuries. But now in modern times, people realize that fetuses move before people feel them.
Antonia: 54:51
Yeah, it sounds like these beliefs have continued to go back and forth just over the centuries and it’s still the current debate of when is the fetus a person? That’s right at the center of all the abortion discussions. But I guess the idea of quickening was a key milestone and something that many different cultures put a lot of prominence on, whereas today the main significance probably is the great reassurance that the mother gets that now she knows the fetus is alive, she doesn’t have to depend on us doing an ultrasound to show that it’s still moving.
Howard: 55:25
We don’t have to get into the theologic debates, but it is an interesting concept and I’m sure a lot of the listeners who have read a lot about this again vis-a-vis abortion. So the old English word quickening just really means to become alive. Anyway, there’s a ton of other interesting obstetric stories in the Bible, again mostly in the Old Testament, including birthing positions and perineal lacerations and just all sorts of interesting things, and I will put an article, if folks are interested, that has some of these stories collected in it. A lot has been written over the years.
Antonia: 55:59
Yeah, this article you’re linking to.
Antonia: 56:01
I think it was an interesting read. I think it was a little bit lighthearted. I can’t tell what the author’s backgrounds are they’re from South Africa and it’s written in the 1960s but it seems a mix of ancient Hebrew scholarship and historical expertise, especially from around the timeline of the Bible. They also tie in some other scriptures relating to what’s in the Quran, just as a comparison, and then of course also they’re very well-versed in obstetric concepts and a lot of this article. It does seem like they might pick one word from any given passage and then massively speculate on all the different possible interpretations, maybe overthink some of them, and some of them are not that interesting. They spent a whole page just about birthing positions. I think that wasn’t the most interesting to me. But one example I’ll just mention is a commentary. There’s a person in the Old Testament who was named for the fact that the mother had a perineal tear. Like they were named, basically a word for perineal tear. So I think that was a little bit unfortunate for the baby, if not also the mother.
Howard: 57:15
Yeah, it doesn’t say whether it was repaired. I assume in those days they weren’t repaired and whether she went on to have perineal pain or prolapse or a fistula or things like that. But you know, imagine today if someone named their baby fourth degree. That could be a cool name, I don’t know.
Antonia: 57:30
I’m glad that didn’t become an enduring religious tradition. Okay, I guess that that’s our little historical Christmas tidbit there. So we’ll talk about some changes to this podcast that are coming up with our next season. That’s going to start with the next episode in 2025. So we’re going into season nine and we’re growing and changing and bringing in the new year with some new expertise and perspectives and just new talent.
Howard: 57:59
Yeah, this podcast is a lot of work for both of us. I think people don’t may not appreciate how much we, how much time we, spend on it, so it’s going to be great having a bigger supporting cast and crew to help. And so, yeah, we’re going to have some changes in store and an opportunity to work with a lot of great folks, some of whom we’ve had on here before, and a lot that you’re going to meet some new guest hosts and things like that. And we’re going to have gynecologic oncology covered with our old friend Stuart that many of you have heard on here before, and actually he’ll be on in one of the episodes in January, hopefully. But other new specialties too. And so we’re going to have maternal fetal medicine represented and reproductive endocrinology and a series of folks a pediatric and adolescent gynecology, with different talents and different perspectives over the next year to guest host at least every other episode or so and bringing their expertise and time and talents to the podcast too. So we’re excited about that.
Antonia: 58:51
Yeah, we’ll keep doing what we’ve always done, but it’ll be definitely interspersed and sharing the space and the airtime with a rotating cast of people with different backgrounds, different subspecialties, different practice settings, and it’ll just bring some experiences and expertise way far beyond what the two of us just have.
Howard: 59:16
Yeah, and one of us will always be here too, but it’s a great opportunity to expand and get some great folks on board, so very exciting.
Antonia: 59:24
Yeah, so stay tuned.
Howard: 59:26
Yeah, and in fact we’ll be back in a couple of weeks with the first episode of Season 9. And then we look forward to seeing you guys next year, and Merry Christmas.
Antonia: 59:37
Happy New Year. Thanks for listening. Merry Christmas, happy New Year.
