Episode 8.2 Cesarean Under Local, New Literature, and History of Preeclampsia
In this episode, we discuss four tips for Cesarean under local. Then we discuss some new literature including full versus empty bladder during gyn procedures and endometrial ablation vs IUD for abnormal uterine bleeding. We also discuss the inertia of old ideas in obstetric practice. Finally, we discuss the history of the diagnosis of preeclampsia and eclampsia.
00:00:02 Cesarean Delivery Under Local Anesthesia
00:07:04 Emergency Cesarean Delivery Procedure
00:19:47 Bladder Status in Gynecological Procedures
00:29:01 Endometrial Ablation vs IUD for Treatment
00:38:43 Inertia in Obstetrics Practice Trends
00:47:45 Historical Evolution of Eclampsia Diagnosis
Links Discussed
Every Second Matters for Emergency and Essential Surgery – Ketamine
Cesarean delivery under local anesthesia: A literature review
Cesarean section under local anesthesia: A step forward or backward?
Does a full bladder assist insertion of intrauterine contraception? A randomised trial
Surgical Field Separation in Total Laparoscopic Hysterectomy
The evolution of the diagnostic criteria of preeclampsia-eclampsia
Transcript
Announcer: 0:02
This is Thinking About OB-GYN with your hosts Antonia Roberts and Howard Herrell.
Howard: 0:18
Antonia.
Antonia: 0:18
Howard.
Howard: 0:19
What are we thinking about on today’s episode?
Antonia: 0:21
Well, last time we talked about older landmark trials in obstetrics, so today we’ll hit on some more recent highlights, again so recent to us as of July 2024. But first, we have four tips for performing cesarean under local anesthesia, and I’ve almost had to do this before. We got pretty close and then the anesthesia kicked in. So I do love talking about this, because nothing is better than being prepared in that kind of a situation, and none of us would ever wish this scenario on anyone, least of all ourselves. But knowing in advance what you would do could make all the difference in the world, especially when you don’t have time in the moment to stop and think.
Howard: 1:04
Well, right, emergencies happen, and then that’s when you need to be prepared. I think there’s actually a couple of types of cesareans under local that we have to think about. The one you and I are, I think, immediately pondering here is that disaster situation where, for whatever reason, anesthesia is not available. The cesarean needs to happen right now. But actually there are reasons to do cesareans under local beyond just those sorts of dire emergencies. So the emergencies might include any situation where anesthesia is not available or successful, but cesarean delivery has to happen now or you’re going to have a real problem. So any acute event with fetal distress, maybe an abruption, a uterine rupture, a cord prolapse, things like that If you work in a hospital that doesn’t have in-house anesthesia, the situation may come up more often, or more likely to come up, I guess. But even if you do have in-house anesthesia, they might be tied up in another emergency or another surgery and you just don’t have time to wait for them.
Antonia: 2:00
And in the case I’m thinking of that I experienced for them. And in the case I’m thinking of that I experienced anesthesia was there at the bedside but they were having trouble intubating the mother. She needed intubation and that is a separate emergency in and of itself. So you can’t intubate, can’t ventilate. That’s an anesthesia emergency and of course it actually. It was one of those types of emergencies. The seconds were ticking. I was handed a syringe full of local anesthesia by the circulating nurse, but then, right at that moment, the intubation finally was successful. So I didn’t have to infiltrate it, and that’s all to say that it doesn’t necessarily matter where you work. You might be out there thinking I’m not in that kind of a remote place that we have anesthesiologists in house. So did I, and it can still happen. So you have to think about being prepared for the potential of cesarean under local, no matter who you are, where you work at.
Howard: 2:58
Right, and there are actually even the second type, some planned cesareans under local as well, and the protocol for those can be a little bit different.
Antonia: 3:05
Okay, well, let’s talk about when that would happen. That’s obviously quite rare. So if we did that routinely, then maybe we wouldn’t be so daunted about the thought of doing it in an emergency and discussing it like we are right now.
Howard: 3:18
Yeah, well, obviously we’ve been discussing the situation first of all where you have a lack of equipment or resources or the personnel to do normal anesthesia. But there are some patients that actually have a contraindication to both general and regional anesthesia. And there are some situations that come up where there’s a contraindication to regional anesthesia, like, say, a low platelet count, but also then the patient, as you had, couldn’t be intubated successfully. So now you have failed intubation, even though it wasn’t an emergency situation, and any of those planned cases that you might do. You do have more time and you can be more prepared and you can usually use at least things like Intinox, which is the inhaled 50% oxygen and 50% nitrous oxide mixture. You can use other things because you do have anesthesia there. You just can’t put them to sleep or do a spinal or epidural.
Antonia: 4:06
I’m not too sure how often we would know in advance that someone’s going to be a failed intubation. So even this sort of less emergent type of cesarean under local might still not be in a scheduled sense like a routine, planned procedure. It might still catch you by surprise. Let’s say it’s not an emergency, but let’s say that they’re going to try to put the patient to sleep because they already know they can’t be regional. The baby’s doing fine, but they can’t intubate, so then they would have to ventilate her, make sure she’s still stable, then maybe do a quick check of the baby, make sure they’re still doing well and then in the moment discuss the alternatives. And that might be a rare situation where you can actually take your time and do this under local. So as for that Entonox you mentioned, that might also be known to some people as just laughing gas, and a lot of labor and delivery wards are adding this to their toolbox of pain medications at the bedside in the labor room. Otherwise, if not, then they’re almost certainly likely to have it in the OR and other adjuvants might include ketamine that can be administered intramuscular or IV, and we can link to a manual for emergency surgical ketamine, as in ketamine only, not even using local.
Antonia: 5:28
And this is a program endorsed by Massachusetts General Hospital and they worked on this in collaboration with a group in Kenya and this protocol has been used in hundreds of emergency cesareans in Kenya with fairly good results. And in this package they trained people who were not anesthesia providers because that’s the whole idea is do this when you don’t have anesthesia available and they trained them to be able to safely administer a pretty big dose so either two milligrams per kilo IV or five milligrams per kilo IM in an emergency delivery when there’s no anesthesia. So that’s one option out there. But I think what we’re talking about here with using local would enable you to use much less ketamine as an adjunct, because that is a pretty big dose. So let’s go into our four tips for using local for cesarean. So the first tip is have a kit available where you already have everything that you need in it.
Howard: 6:28
Right, so you can have a cesarean under local kit just on your floor and your pyxis or whatever. That’s straightforward to put together. And really what you need is a large syringe, so think a 50 or 60 ml syringe, a needle that you can inject the medication quickly across a long incision, so ideally a larger bore and long like spinal type needle. You can see what your facility has, but say, an 18 gauge needle or even a spinal needle would be ideal. And remember, spinal needles can be bendy and very thin too, so you may have to consider your options and have a backup. And then you need 100 milliliters or even 150 milliliters of half percent lidocaine with epinephrine and a rapid skin prep like a bottle of betadine and a scalpel.
Howard: 7:14
Now, those are the essentials to getting the fetus delivered, and that’s for that real crash and burn section at the bedside. In my hospital and most hospitals, you probably have a full cesarean instrument kit available for bedside use as well. But if you have a little more time, you can also just go to the operating room, even if you don’t have anesthesia there or scrub techs for that matter, and you can use those facilities along with a regular cesarean tray. And still, though, you would need quick access to these syringes and the supply of half percent lidocaine and all those things, and if you have a scalpel, if nothing else, you can get the baby out into safety while you catch up on the other things.
Antonia: 7:50
Yeah, I remember everywhere that I’ve worked there’s been a scalpel taped either in a room or under a counter, for the idea was this is for when, if and when a mother goes into cardiac arrest.
Antonia: 8:05
That’s all you need is a scalpel, and if your OR is further away you might need about four minutes away. So unless the mother is actively getting CPR, then usually for anything else we will still go to the operating room to do a cesarean because we can be there so quickly and again with the cardiac arrest. That’s one situation you don’t have to worry about local or betadine or anything except a scalpel. But of course if you’re in a hospital that maybe it’s farther away than four minutes, and I’ve been in hospitals like that where there’s a long trip down the hall or sometimes we were diverted to the main OR on a different floor. That’s getting into eight or 10 minutes or more. So if you have a situation like acute placental abruption, then you probably can’t wait that long and you might have to do this on an awake patient at the bedside. So having a kit that has the local is going to be great.
Howard: 9:16
Yeah, all of my cesareans have to happen in the main, or we don’t have ORs on the ward. But yeah, we’re still just a couple of minutes away. It’s just underneath us by elevator, but that doesn’t mean a room’s always available or that sort of situation.
Howard: 9:31
So you still have to be prepared. Okay, let’s review the dosing of this lidocaine, because that might be the biggest thing that folks will get caught up on in the moment when you’re doing the emergency. So remember that you can use seven milligrams per kilogram of lidocaine with epinephrine, but may help to put a sticker with the amounts available per given body weight or some averages. If the patient is fairly normal size, you can approximate that she weighs, say, 155 pounds, which is 70 kilos. Her maximum safe dose then is 490 milligrams, and if half percent lidocaine is five milligrams per ml, that’s 98 milliliters, so 100 mls. If she’s obese and closer to, say, 220 pounds or 100 kilograms, then you can use up to 140 mls, and if she’s very petite, you’ve still got at least 50 mls easily to work with, which should still cover a decent area on the patient in terms of anesthesia.
Howard: 10:30
Now, those aren’t things you necessarily will remember in an emergency.
Howard: 10:34
So having a kit designed with all those things that you need immediately available, plus a little sticker or piece of paper in there with those doses and doses of other meds you might use, can help out a whole lot.
Howard: 10:46
If you’ve made a cesarean tray for bedside use, it’s very easy to include other things like a pack of sutures, but in most cases, by the time the baby is born, you could put a few clamps on if you need to, or pack the incision with sponges and then move to a regular operating room to finish closing up as your other personnel become more available. So that jumped the gun a bit. On our second tip, I guess, which is to have a checklist or a cheat sheet in your kit that gives you the maximum amount of local anesthetic you can use for whatever product you have, and that varies too, because there may be shortages. You may not have half percent always, but you can put other information on there as well, like you could put the doses of ketamine or other sedatives that you might use. Which gets us into our third tip.
Antonia: 11:31
Yeah, so we briefly mentioned using the Entonox, the laughing gas and ketamine even in the labor room, but certainly if you’re in the OR, the anesthesia provider could do this for you or somebody that’s taking care of that. If, let’s say, you don’t have an anesthesiologist but an ER doctor comes up, for example, and you also have the option of giving two to four milligrams of midazolam IV or 100 micrograms of fentanyl IV and most of us are comfortable doing the fentanyl at least we do that all the time anyway just for labor pain. And you’ll want to give the patients 100% oxygen via face mask and monitor their pulse oximetry as well as their blood pressure. And, if possible, it would also be a good idea to have the EKG monitors applied, which usually a crash cart would have, even if you’re on the labor and delivery ward and not in an operating room.
Howard: 12:26
Yeah, and you really can use that combination of all those IV medications at the same time if you like, Okay. The fourth tip is to try to use a more delicate and gentle approach to doing the cesarean. So this sounds the exact opposite of what we might do during a normal stat cesarean, where we’re furiously cutting and pulling and pushing as fast as humanly possible. But actually the more you can be gentle with your dissection and exposure and extraction of the baby, the better. The fascia all the way across, rather than making a small nick in the middle and bluntly tearing it as we might normally do according to the evidence-based scissoring techniques that we’ve discussed. You just need to be more gentle.
Antonia: 13:12
Yeah, because if they have a lot more sensation they’ll feel that tearing a lot more than they would. Just a sharp scalpel and just doing it that way would be a completely different mindset than what we normally would have, especially if it’s oh, we need to get the baby out now, we don’t have time to do anesthesia, we don’t have time to go to the, or acute abruption, that kind of thing we would not be thinking of. Let me go slow and gentle.
Antonia: 13:40
So the bone. A bonus step here is knowing how to infiltrate the lidocaine in the most effective way. So obviously you want to inject it along the skin incision line and the rectus sheath layer. But the peritoneum is going to hurt as well and you can ideally have a little bit left that you haven’t injected. By the time you get to the peritoneum you can actually just dump the rest of it into the peritoneal cavity. Some authors actually start below the umbilicus with their infiltration and use a spinal needle to inject kind of a swell of the anesthetic along the incision from there. Yeah, as they pull the needle back, they inject along that line. That technique would cause some blockage of the pain signals at the nerves that penetrate the rectus muscles through the midline and many people would assume that that’s only if you’re going to do a vertical skin incision. But even if you don’t, if you inject as if you were doing a vertical incision, you inject along that line. It’ll give you some fascial blockade as well.
Howard: 14:54
Those nerves travel downward, yeah.
Antonia: 14:56
And then, of course, you can inject or dump the anesthetic onto the peritoneum, over the uterus, prior to making your uterine incision. But it’s really going to be the skin and fascia and those rectus sheaf nerves that are going to be the most important ones to block.
Howard: 15:14
Yeah, and that injection and the premedication and all those things can take a few minutes to do properly. So you have to remember to breathe. If the mother is awake and able to react to pain, you need to take that time. And you mentioned vertical skin incision. When a patient’s coding, it may be advantageous to do a great big vertical incision and then a classical incision on the uterus because you have no time to mess with the bladder blade. You don’t have retractors there necessarily, you may not be able to give great fundal pressure or any additional kind of dissection and in that scenario you probably also want the increased abdominal exposure for additional maternal treatments, depending on why she’s in arrest or whatever may be going on. Let’s say this is a code or a trauma or something like that. But what we’re talking about here is doing a cesarean on an awake patient and in most cases very emergently. It’s going to be hard for us to generalize whether the vertical or low horizontal type incision is better. So I think that’s situational.
Antonia: 16:10
Yeah, that might not be something we normally think about as in how would I do this at the bedside without any retractors, but we almost exclusively do the low transverse incisions across the skin when we’re doing them in the OR, and then we do the low transverse uterine incisions and then usually the baby comes out, sometimes a very tight squeeze through that low transverse uterine incision if they’re full term, and that’s our day to day, that’s our comfort level.
Antonia: 16:40
But again, that’s in the context of being in an operating room having retractors, maybe having a scrub tech that’s holding the retractors or giving fundal pressure when it’s time for the baby to come out, or even, let’s say, you can’t easily get the head out, they can hand you forceps or a vacuum. So think about all of that in advance for a patient, whenever you can, just as a little thought experiment of what if I had to do this at the bedside without all of that help? So think about what is this patient’s surgical history? What kind of scar tissue might they have? What’s the habitus of their abdominal wall under both vertical or horizontal approaches? What’s the fetus’s condition?
Howard: 17:21
Yeah, and if you are going to make a transverse like a Pfannenstiel or Joel Cohen incision, at least make it more generous so that you’re not struggling with a patient who doesn’t have very much anesthesia, like, let’s let the baby fall out here.
Howard: 17:33
We don’t need to make the world’s smallest incision like we might normally try to do, and if the BMI is 80 or something, for example, the vertical incision might waste more time.
Howard: 17:43
If you’re going through some of the thicker areas of subcutaneous tissue, I think most people will tend to default to the Pfannenstiel or Joel Cohen that they normally would do.
Howard: 17:53
So if you’re truly at the bedside and don’t have the full retraction and lighting that’s available in the OR, then you probably need to be generous with the incision and, for that matter, for the more obese patient, maybe a vertical incision is what you need, because the Panus and everything just self-retracts and you don’t have to have all this assistance that you would normally do. So just think about what’s my most direct and easiest route, without help, to get this baby delivered. And then you can always wait for the patient to be then put under general anesthesia when everybody catches up or your team arrives, and then do the closure under a nice controlled circumstance that you’d like to do. And remember you can always pack the incision too if it’s bleeding and simply hold pressure until everything is caught up and people are ready to go. Put clamps on big bleeders and then take your time and close properly, and don’t forget to give an antibiotic, because we probably forgot to do that at this point.
Antonia: 18:40
Yeah, okay, fun stuff. Hopefully most people don’t have to do that, but you want to be prepared regardless. So let’s move on and discuss some recent literature.
Howard: 18:50
All right. In this month’s edition, the July edition, of the Green Journal, there is this randomized controlled trial that looked at endometrial sampling with a pipell in patients with a full bladder, compared with standard care, which would be an empty bladder, I guess. And I thought this was interesting because we put a picture a few months ago on the Instagram of a uterus where there was a full bladder and also, in the same patient, an empty bladder, and the position of the uterus was just dramatically different. And I’ve been thinking about whether IED insertion with a full bladder would make the procedure less painful because that utero-cervical angle would be flatter. The uterus would be more in a mid position, as it was in that picture.
Antonia: 19:30
Yeah, that was quite an impressive difference in those pictures and it makes the fundus of the uterus much more midline or in an axial position compared to at least the more extreme anteversion or retroversion that we might see in other cases. But then traditionally we think the speculum placement would be so much more painful with a full bladder that we have the patient empty her bladder, we have her void beforehand and in a lot of cases we also want that urine sample to confirm a negative pregnancy, for IUD insertions at least. But in this new study of endometrial biopsies in which they didn’t need a pregnancy test, they actually found that doing the sampling with a patient having a full bladder reduces the initial PIPEL insertion failure rate, also the procedure-related pain, the duration of the sampling and, not surprisingly with all of those, also increases patient satisfaction compared with the standard process.
Howard: 20:33
Yeah, and I think if you look at that picture again that we put on the Instagram, you can see why that is so. Of course, in patients who are getting into mutual biopsies, as you said, you don’t always. Sometimes you do, but you don’t always need a negative pregnancy test right before. But I think this makes a lot of sense and always need a negative pregnancy test right before. But I think this makes a lot of sense. And this is some empiric data about whether or not the full bladder thing is really an issue or not in terms of increasing pain with speculum exams and clearly these patients had less pain and were happier with an easier procedure. And I really do feel like this could be analogous to inserting a Kyleena in a younger nulliparous patient and that we might see a similar difference if she went from extreme anteversion to midline flexion of the uterus because her bladder was full and pushing it down.
Antonia: 21:18
One of the goals in this study was to use the tenaculum less or not at all if possible with these procedures, and so they tried not to use it, on the first attempt at least, and I think that’s probably what most of us do as well. We have patients with empty bladders, and then they typically will be anteverted or retroverted. Most patients are anteverted almost 90% and a lot of times if we try to put the pipelle in without a tenaculum, we can just see that cervix just push out of our view. So then we just have to take the tenaculum out. But in this study they cut their failure rate in half, which they defined as not getting adequate pathologic specimens, and they cut their initial pipelle entry failure in half as well. So that’s pretty significant. When you’re thinking, this is an intervention that is completely free. You don’t have to buy anything or obtain anything. It’s just having the patient do things in a different order.
Howard: 22:18
Right and I think there’s a lot to this study and again it calls into question how much we tend to think of a full bladder with a speculum exam as being a big deal.
Howard: 22:26
So I’m glad this study was done because I really have been thinking about that since those pictures I know I’m weird. You can imagine putting an IED or doing an endometrial biopsy in the uterus in that ultrasound picture with the empty bladder and then with the full bladder, and it might even reduce the risk of perforation if you had a large enough series to find that. Because by changing the angle there between the cervix and the uterus you make, in making that straighter entryway, you’re going to have less perforations. You would think through the back wall of the uterus or at least lessen the amount of times that we need to use that tenaculum and then pull very significantly with it, which might lead to less of a vagal response for some of those patients and of course, improve the experience for insertion for patients of IUDs, particularly if you can avoid using the tenaculum. So I like to see a larger trial of a full bladder versus an empty bladder for IUD insertion. So if some resident out there is looking for a project, let me know.
Antonia: 23:23
Yeah, the only practical problem here would be the pregnancy test, because many patients getting an IUD inserted we have to have them give a pregnancy test right before insertion. A lot of times we can’t just rule out pregnancy just based on their history. Sometimes we can, but in almost in the majority of cases we can’t. So we might have to come up with a scheme where we have them come to clinic with as full a bladder as they can and then pee just enough in the cup that we could get at least a couple drops of urine and do that pregnancy test while otherwise leaving their bladder full. So that might be a little bit awkward for them and maybe some of them would be like I just couldn’t stop peeing. But I’m sure some patients could, especially if they knew that this was going to make their procedure that much better. But yeah, if anyone’s interested in working on this as a randomized controlled trial, please let us know.
Antonia: 24:17
I did just a quick background search. I found one randomized controlled trial on this already, but it was done in Britain in 2012. So I’m not even sure if they had any of the same devices we do now or what other variables might have been different. I was only able to access the abstract. The rest of it was behind a paywall. But in this trial their conclusion was that they didn’t find a difference, but I’m sure that it’s worth looking into again.
Howard: 24:44
Yeah, I’ve definitely seen particularly with Skyla or Kyleena, the smaller ones a lot of young nulligravid patients. If they’re mid position, if you look beforehand, they just slide right in no problem. And then the ones that are very introverted are the ones that you struggle with and have to put a tenaculum on. So I don’t think that they used the smaller caliber IEDs, so it’s something, and just have to get the pregnancy test situation and then we can do a little study there All right.
Howard: 25:12
Well, there was also a really great article in the same July issue of the Green Journal about surgical field separation at the time of total laparoscopic hysterectomy, and I love articles like this one and that last one because they tend to challenge sort of traditional dogma. That’s based upon what makes sense to us and let’s actually see if it’s true with an empiric study. So it makes sense that you wouldn’t want to do a procedure with a speculum with a full bladder, but the data says that actually patients tolerate it well and may even do better, in terms of outcomes for endometrial biopsy at least. And in this case the authors wanted to study whether or not having a completely separate vaginal prep from the abdominal prep and then switching your gloves anytime you go back and forth between the vagina and the abdomen, having the surgeon and the team switch out their gloves. They wanted to see if that actually made a difference in outcomes for the patient in terms of infection rates and things like that.
Antonia: 26:11
So many OR teams are very strict about this. Others may be less so, but I think the tradition for almost everybody out there is to keep the two fields separated. So this would apply especially to laparoscopic hysterectomy or any other combined procedures like maybe a diagnostic, like a hysteroscopy with laparoscopy, maybe an endometrial ablation with a tubal ligation, something where you’re doing things through the abdomen and also through the vagina, and even with V notes, if you are doing V notes and then you end up having to get abdominal access too, even though in that case you have the same laparoscopic instruments that you would use from above. But the traditional dogma is now you need a whole separate set of those same tools with a separate camera and everything, because the first set touched something that touched the vagina. So the question is does this separation of fields, of abdominal versus vaginal surgical fields, make a difference?
Antonia: 27:13
Let’s say, if you don’t change your gloves when you’re going back and forth between them, maybe even not changing the instruments potentially, what if you need to reach down? You’re at the abdomen and there’s a vaginal manipulator. What if you need to reach down with one hand and grab that manipulator to move the uterus around or manipulate the Foley catheter with your hand? Can you take that same hand back up without switching gloves? Or have you committed a cardinal sin and contaminated yourself and now are you going to give her this terrible surgical infection because of what you’ve done?
Howard: 27:48
are you going to give her this terrible surgical infection because of what you’ve done? Well, this was a retrospective look at exactly that question, where one surgeon religiously followed the field separation principles while the second surgeon did not. But otherwise they use the same operating rooms and staff and the same environment overall and they did the same surgeries and each surgeon did about 300 cases, a little more than 300 cases, and they found no difference in infection-related outcomes and really no difference at all. So I think I was already a believer that field separation isn’t necessary and it’s silly, in particular with hysterectomy, because you’re entering the peritoneal cavity through the vagina and through the abdomen, so both sites are really clean, contaminated. But in the age of preoperative antibiotics, this field separation doesn’t seem to be important.
Antonia: 28:36
Yeah, I see what you’re saying. Like you have insufflation and at the same time you have the vaginal mucosa open to the peritoneum and also the abdominal incisions open to the peritoneum, like it’s just open and there’s air.
Howard: 28:51
You’re creating a continuum, yeah.
Antonia: 28:53
Yeah, yeah. So changing your gloves is like how is that going to prevent little cells from moving around inside? But that still raises the question about what if we were doing a procedure where pre-op antibiotics were not otherwise indicated, that they already are just for doing a hysterectomy. But let’s say we were doing a procedure where pre-op antibiotics were not otherwise indicated, that they already are just for doing a hysterectomy. But let’s say we were doing a diagnostic laparoscopy and then hysteroscopy DNC. Neither of those separately require antibiotics and generally we’re changing our gloves and so we generally wouldn’t give antibiotics just because we’re doing those at the same time. So this study might not apply to those cases yet.
Howard: 29:32
I think that’s right. You can’t take this data and apply it to that concept, but in that case we’ll just do your laparoscopy first and your hysteroscopy second, and then you don’t need to change your gloves and you can even reuse lighting, light cords and things like that. I do think some people do it in the opposite order, because they’re worried about perforation or something at the time of hysteroscopy. But that’s unnecessary. If you’re going to perforate at the hysteroscopy, you can deal with that when it happens. But we don’t routinely do laparoscopy after hysteroscopy because we’re concerned about perforations.
Antonia: 30:05
Yeah, like if clinically you didn’t see any signs of perforation, you didn’t sound much deeper than you expected to, then yeah, there’s no reason to go back up and look. But obviously, if any of those things do happen, think that they’re going to do the hysteroscopy and then, when they’re done with that, then put in a uterine manipulator before they go up to the abdominal side and do whatever they’re going to do laparoscopically.
Howard: 30:40
Right, I’m sure that’s right, especially with the exception, then, of doing a chromopertubation. You would need to do that, but if you’re not doing a chromopertubation, well, uterine manipulators are just in and of themselves, are usually unnecessary for just diagnostic laparoscopy. If you want to put something in the vagina, use a sponge stick which you can do without contaminating yourself. But, yeah, if you need to put a uterine manipulator on, you’re doing maybe some complex cul-de-sac surgery or something like that, or you’re doing a chromopertubation, then, yeah, you should probably still change your gloves, because this study doesn’t apply to that procedure, especially if there’s no preoperative antibiotics being given.
Antonia: 31:20
Well, and some people would give antibiotics for the chromopertubations to empirically if there’s a history of PID or Sure yeah.
Howard: 31:30
So another opportunity for more studies. Same study done with different surgeries.
Antonia: 31:35
Yes, okay, well, let’s keep moving. So in the May 2024 edition of the Gray Journal there was an interesting paper that compared the 52 milligram levonorgestrel IUD to bipolar endometrial ablation effective in treating the heavy menstrual bleeding at the point of a two-year follow-up, and that was called the MIRA trial, m-i-r-a. In this follow-up study they got most of the participants to fill out some more surveys to see how they were doing further on down the road and they found the overall rate of re-intervention was not different between the two groups. There were some women in the IUD group who then went on to receive an endometrial ablation later on and a non-statistically significant greater number of women in the ablation group who went on to eventually get a hysterectomy. But overall the re-intervention rates meaning getting some further intervention to treat heavy bleeding were basically the same between whether they got an IUD or an ablation initially.
Howard: 32:51
Well good, I think that the original trial and now this follow-up are very important to our clinical practice. It’s actually very hard to justify, in my opinion, doing endometrial ablations, at least as a primary treatment, when a person has not yet received an IUD as a treatment for their abnormal bleeding.
Howard: 33:09
These endometrial ablation devices became a craze because they were very profitable, frankly, for doctors to do in the office, and there’s no way of knowing for sure, but it seems like maybe a majority of women who received endometrial ablations in the last 15 to 20 years didn’t really meet the indications for them. We’ve discussed before how this may in fact be leading to part of the increased rate of advanced stage endometrial cancers that we’re seeing in the last few years, as women who were viewed as poor surgical candidates, such as very obese women, were pushed towards endometrial ablation rather than a hysterectomy. But had those same women received a progesterone-eluting IED, they may not have developed cancer at all, or, if they had, their irregular bleeding would have been obvious enough perhaps to lead to an earlier stage of diagnosis. I think endometrial ablation has been overutilized in our profession, not because it’s not an alternative to hysterectomy or that hysterectomy is the right thing to do in every case, but just because it’s not better than a simple in-office placement of a levonorgestrel IUD.
Antonia: 34:15
Yeah, and it’s not a bad thing that some of the patients in the IUD group still went on to get ablations or even hysterectomies later on, because everything has a failure rate. But it is a significant cost and morbidity savings to most patients if they’re able to manage their symptoms on an IUD alone and when you consider the long-term consequences potentially of cancer, prevention with the levonorgesterol might actually have a mortality benefit in the long term. If there was able, if someone was able to do a long enough study on that and not just endometrial cancer yeah, not just endometrial cancer.
Howard: 34:54
Ovarian and cervical cancer risks are reduced with these IUDs. So abortion doesn’t give you any of those benefits.
Antonia: 35:00
No. So, especially for patients with risk factors for endometrial cancer, if they’re considering ablation, we need to make sure that we are emphasizing the equivalence of outcomes between that and IUD and the additional advantages of the IUD. But a lot of people come into our office already having heard horror stories about the IUDs, more so than about ablations. I get a lot of patients that come in. They want an ablation, they do not want an IUD, they don’t even want to think about it. So it’s common for a lot of patients, I think, to push straight for the ablation or for a hysterectomy, I’d say. The IUD may take a bit longer to ramp up and have its full effect on a patient, but usually by about six months after it’s been placed, it’s usually working pretty well.
Howard: 35:49
Right and patients are asking for it because we’ve primed them. It’s just like patients who ask for yearly pap smears.
Howard: 35:56
We’ve taught them over the last decades that that’s what they should get, and they’ve had friends or they’ve read about it. But another reason to consider the IED is just immediate access. That’s something you can offer right now, on the spot, and maybe even get a biopsy at the same time, if it’s indicated it often will be. And then if they still don’t like it, at least you’ve tried and you can move on to ablation. And also I’ll say you don’t have to worry about sterilization. You know the patient may not be sterilized and you’re considering an ablation, and now you have to consider concomitant sterilization and additional surgical risk. The IED covers all of that. So okay, well, another interesting article in that same May edition of the Gray Journal was a population-based cohort study of the five-year outcomes for a group of children who had received tocolysis after preterm premature rupture of membranes, or as the British call it, preterm pre-labor rupture of membranes.
Howard: 36:51
Now I of course collect all of these tocolytic-related studies and we talk a lot about these in previous episodes. But I am still dumbfounded by the fact that so many people so adamantly use tocolytics. All the new interns out there this month and their residency programs are being taught routinely to use drugs in the case of preterm labor or in the case of preterm rupture of membranes, that have never had a proven benefit and there seems to just be so much inertia in our thought processes. I’ll talk about that more in a minute. But this particular study was a follow-up of the so-called EpiPage 2 study. That included pregnant patients with PPROM between 24 and 32 weeks gestation that had received tocolysis, and this was done in France. Now they looked at these children at the age of five or so and they concluded that there was no difference in their neurodevelopmental outcomes and that today the health benefits of tocolytics remain unproven, both in the short and long-term cases.
Antonia: 37:50
Yeah, so nothing new to see here, but further evidence that tocolytics basically are a placebo intervention. We talked about them way back in season two on episode three and new interns who find that statement odd should go back and listen to that episode next. But I think it’s a fair statement to say that no well-designed placebo-controlled randomized clinical trial has ever shown any improvements in neonatal outcomes from the use of tocolytics.
Howard: 38:20
And ultimately that’s what they’re good for. It doesn’t matter even if labor is prolonged or more patients receive steroids or anything like that, which no study’s shown those things either. What ultimately matters is do babies born preterm do better if they’ve been exposed to this intervention or not? That’s the outcome that actually matters. Everything else, at best, is a surrogate outcome. And the answer is no. And let me get back just for a minute to inertia.
Howard: 38:46
I was thinking about this the other day about how ACOG and other professional societies and just the consensus of practice has so much inertia associated with it. If we’re already doing something in practice, then we tend to discount new evidence that comes along, even very compelling evidence that we should maybe change that practice, even if that practice is wrong. So back when we did that episode six seasons ago, as I recall, we were discussing a new study that had just been published in the Green Journal that showed that nifedipine, the most commonly used tocolytic now, was completely worthless as a tocolytic, even for the so-called steroid window benefit. And it was a really good study and not the first study to say that it didn’t work and it agrees with the consensus of the scientific literature that already exists. Yet, as you said, new interns around the country this month are being told to give patients procardia who present with symptoms of preterm labor.
Howard: 39:41
It’s really amazing, actually, in how this inertia mindset stops us from following scientific and evidence-based medicine. Now that study that was published about nifedipine had it found efficacy for the drug, it would be lauded as one of the greatest studies ever published, even though it disagreed with all of the previous evidence that said it didn’t work. In other words, if new evidence agrees with what we’re already doing, then we love it, even if what we’re doing is wrong and inconsistent with everything else we know. But if new evidence agrees with all the existing evidence but finds itself at odds with what we’re actually doing in practice, then we just tend to discount it.
Antonia: 40:22
And that’s human nature, it’s confirmation bias and it’s the therapeutic imperative. We’re in no way immune to that, even though we might think that we’re smart and rational and we’re delivering quality care. But there’s all these other reasons why people don’t want to change what they’re doing, like what is the local and the community standard? What are the patient’s expectations and demands? And is there a risk of liability if we don’t do the thing that, even though it has no evidence, has this trend of everyone else is doing it? If I don’t do it and something bad happens, am I still in trouble?
Howard: 40:59
Yeah, it’s an emotional summing up, or in other words, cognitive bias, implicit bias, of all of those sort of factors and incentives, and that’s called the commission bias. When you’re biased towards doing something and you combine that with the therapeutic imperative, where we just feel like we have to do something for patients who are in trouble, then we get all sorts of interventions that don’t have a lot of great science behind them and if they do have any impact, it’s very marginal at best and has to be carefully weighed against potential risks. The whole history of obstetrics is filled with these sorts of things. But that differs from a skeptical, empiric view of science, where we look first for proven benefit before we expose patients to potentially harmful interventions.
Antonia: 41:46
A lot of these interventions like magnesium for cerebral policy, prevention or even fetal monitoring and labor or things like having an empty bladder for a speculum exam, as we just discussed, have all crept into our practice not because of scientific studies but because of maybe weak evidence or expert opinion or just a theoretic application, and then they just sneakily become standardized and because of this inertia that you’re talking about, then people will tend to ignore the actual scientific studies that say that they don’t work.
Howard: 42:23
Yeah, and that’s called the prevailing bias, and there is some value to that. This isn’t all a bad thing. You don’t want to be pushed around by every crappy little new study that comes around and says something different than what most of us are doing. But there’s also a line where the prevailing bias of practice becomes so different than the scientific consensus of the literature. And in the case of tocolytics, the consensus of the scientific literature is that they’re ineffective and don’t need to be used, but the prevailing bias of the practitioners is that we should use them all the time, and so when this conflict exists, well, I guess I get angry.
Antonia: 43:02
Yes, you do. So maybe we should move on to another paper, because there might be small children listening and I can feel some strong words.
Howard: 43:10
The tension.
Antonia: 43:11
Coming up. Yes, Okay.
Howard: 43:13
Well, I will say before you cut my microphone off that this inertia is really evident in our professional societies. If we have advocated for a particular practice as a standard of care for a number of years, even when it’s based in sketchy or weak or bad science, it’s amazing how hard it is to change that practice. And I think this is evident even in the recent new study about administering steroids between 34 and 37 weeks, which called the ALPS study into question. We talked about that recently. The ALPS study itself, if you look at the data carefully, really showed almost no benefit in most of the subpopulations that were studied, and the benefit that was found wasn’t really clinically important A couple of hours of oxygen, and so it’s the sort of thing that normally wouldn’t be adopted into practice. And then a new study is published that we talked about recently, which says that it doesn’t even have that reported small little, tiny benefit that the ALP study claimed. Yet here we are still doing this practice of steroids after 34 weeks, instead of saying that we might have just been wrong and gone too far.
Howard: 44:21
And I think the important thing for residents to learn is to not be too dogmatic about these interventions, because you may be surprised to learn in five or 10 years that we do change our recommendation as new studies come out.
Howard: 44:34
So if you’re too married to low-dose aspirin for prevention of preeclampsia, or steroids between 34 and 37 weeks, or tocolytics or magnesium for prevention of cerebral palsy and neonates or a lot of other the controversial things that we talk about on this podcast then you’ll really struggle over the next 5 or 10 or 15 years as new papers show that those things are all rather ineffective and we finally do change our practice. But if you realize that the evidence is weak at best and the magnitude of benefit is subtle at most if it has any magnitude of benefit at all as in the aspirin, I think does have one, but how much we don’t know Well then you won’t be too troubled if we change our recommendation to higher dose aspirin, let’s say in a couple of years, based upon some of these European studies. So we don’t want to get too dogmatic.
Antonia: 45:24
Are you a medical nihilist?
Howard: 45:28
I don’t think so at all. I’ve been called that. There are a lot of things that we know are effective, although we do tend to exaggerate the benefits often of those effects. But when something is clearly beneficial we should use it, and use it often and every time in the right population. I think prophylactic antibiotics at the time of C-section or hysterectomy we’re just talking about Huge difference in outcomes. No excuse not to use it. But we do have to guard against indication creep. So just because something is good in one population doesn’t mean it’s good in a population that kind of looks like that.
Howard: 46:00
One Antibiotics may be good at laparoscopic hysterectomy but that doesn’t mean they’re good at diagnostic laparoscopy, for example, even though a lot of people give them. And we have to determine that something works before we use it, not just that something is safe or innocuous to use. That’s what we’re doing right now with nifedipine as a tocolytic. If anyone actually thinks that it’s effective, I would love to hear from them. We’re just using it because it has the best safety profile of the sort of options out there that we can say are tocolytics that we’re using.
Howard: 46:31
And again, just fulfilling this therapeutic imperative and maybe this idea that we did something even though it didn’t work, and if you’re doing it for that reason, like I don’t want to get sued and I want the mom to think I did everything we could, that’s the best and most honest argument you can make for it. I might even have some respect for that argument if that’s the one that people made. But unfortunately our residents learn that these things are like super important and super effective. Not that this doesn’t work, but we’re doing it to cover our butts and they don’t understand that the real science behind those interventions. And over time those residents grow up to be attendings. And here we are where everybody super, super exaggerates the potential small effect of some of these things and then they lose sight of the literature.
Antonia: 47:17
Well, on the last episode we talked a little bit about the history of magnesium sulfate for treatment and prevention of seizures, but we didn’t really talk about the history of preeclampsia itself. And remember we wanted to do regular history segments but now we owe two history segments in a row because you got us a little off track last season.
Howard: 47:40
I got us off track.
Antonia: 47:42
Yes, you All right.
Howard: 47:44
Well, that’s fair. Well, we’ve obviously understood for a long time that pregnant women may sometimes have seizures and then perhaps die afterwards for whatever reason. So the Greek word eclampsia means a light burst, and we think this term was first used in 1619 by Johannes Verandius to describe these seizures in pregnancy. But Hippocrates recognized that headaches and convulsions were a real problem during pregnancy for some women and that it was often fatal. If you saw that by the 18th century we realized that delivery was the treatment and we started to recognize a difference between eclampsia and epilepsy, where headaches tended to precede eclamptic fits, but other symptoms and obviously a different type of recovery and things like that were associated with epilepsy.
Antonia: 48:31
But at that point in history nobody really knew about the association with blood pressures and eclampsia.
Howard: 48:37
Right. It’s interesting how our understanding of many disease processes follow our ability to do certain tests, and that’s still true today, even though we may not realize. It’s true because we don’t know what those future tests or paradigms will be. But we will think of many diseases today differently in the future, as we develop new abilities or new understandings to test for conditions that we don’t even really appreciate right now. In the 19th century we started having an understanding about testing for protein in urine, among other things, and with that new knowledge then, by the middle of the 19th century, we realized that eclampsia was associated with proteinuria, but at that point we still had no real way of measuring blood pressure, so that wasn’t on our radar at all.
Antonia: 49:22
And a lot of what they called toxemia at that point was then thought to be related to a kidney disease, right because of the proteinuria.
Howard: 49:31
Exactly, and a lot of this was actually called Bright’s disease, which is another interesting phenomenon. Bright’s disease was first described in 1827, and it was characterized by swelling with protein in the urine, and once we had the ability to measure blood pressure, we also learned that it was associated with hypertension and you could develop coma or strokes or seizures or blindness if you had Bright’s disease.
Antonia: 49:53
Yeah, that sounds like preeclampsia.
Howard: 49:55
Right, and as a generation of physicians were learning about Bright’s disease, then they started seeing Bright’s disease in their pregnant patients, or at least believing that that was the cause of those problems in a certain percentage of those sick pregnant women of Teddy Roosevelt. She and Teddy were married when she was 19, and a couple of years later she became pregnant in the summer of 1883. And she was otherwise a young, healthy woman for everything that we know about her. And she ended up delivering on February 12, 1884, at 8.30 in the evening, while Teddy was away in Albany, New York, where he was then a member of the state assembly, and he received a telegram that the child had been born and made plans to return to New York City that next day, but then received another telegram telling him that she was semi-comatose and really not doing well. She stayed like that for several hours before eventually dying, and afterwards, during her postmortem examination, they diagnosed her with Bright’s disease or at least undiagnosed kidney failure.
Antonia: 51:04
And they still didn’t have the ability to check her blood pressure right. So this sounds like preeclampsia, followed by maybe she seized or had a coma or a stroke or some other type of an organ damage that we would consider now preeclampsia with severe features, and remember that eclampsia does sometimes present as a coma, rather than a seizure, due to the underlying cerebral edema.
Howard: 51:30
Yeah, exactly. So yeah, the idea of blood pressure wasn’t on anybody’s radar in 1884. There’s a famous page from Roosevelt’s diary on that day I’ve seen this on the internet as a meme that she died. She died on Valentine’s Day then, and he simply wrote an X large X on the page and then wrote underneath the light has gone out of my life.
Antonia: 51:50
That’s so very sad, but the child survived right.
Howard: 51:54
Yeah, so this was Alice Roosevelt, which was their only child together, and Roosevelt, of course, later remarried before becoming president. Okay, yeah, Alice Roosevelt, which was their only child together, and Roosevelt of course, later remarried before becoming president.
Antonia: 52:01
Okay, yeah, alice Roosevelt. She had a very interesting life and people should probably look her up on Wikipedia. It’s too much for me to get into, but she was a very interesting lady.
Howard: 52:12
Well, he did remarry and had more children with his new wife, Edith, who apparently didn’t have preeclampsia ever. But he’d been so heartbroken about Alice’s death that he refused to ever talk about her or even call his daughter Alice by that name. He called her by her middle name instead.
Antonia: 52:29
Yeah, imagine if they had had blood pressure meds, blood pressure cuffs, blood pressure meds, maybe some magnesium or something. But when did the blood pressure become a part of this diagnostic process?
Howard: 52:42
Well, it was around that time that the blood pressure cuff, in a very crude form at least, was invented in 1881 by Samuel Siegfried Karl Ritter von Bosch.
Antonia: 52:55
That’s like an unending name.
Howard: 52:57
Right. That’s a very good name there, Well hang on, because the blood pressure cuff was then improved quite a bit to make it more usable, in 1896 by Scipione Rivi Racci.
Howard: 53:09
Oh goodness, I don’t have any comments on that one, and I probably butchered it too, but these people like their long names over in Europe, but these people like their long names over in Europe.
Howard: 53:19
So anyway, riva Rocci was an Italian, but he really made the blood pressure cuff something that was useful, actually practically useful. And this Italian with the ineffable name was visited by Harvey Cushing, who made drawings and sketches of the device and then came back excited to the United States and made some improvements and then started using it at Johns Hopkins to monitor blood pressure during intracranial surgeries. It was after this that the blood pressure cuff was further refined and made popular for use in the US, and then we finally started seeing medical studies which incorporated the measurements and concept of blood pressure into all sorts of different diagnostic and patient areas. So, interestingly, the first edition of Williams Obstetrics, which was written at Johns Hopkins and published in about 1903, doesn’t mention blood pressure in the entire book. But then by the second edition, which was published in 1908, we finally see at least an introduction of the concept of hypertension in pregnancy. And I suspect that Williams had a leg up, since he was at the same hospital as Harvey Cushing.
Antonia: 54:21
So did he relate hypertension to toxemia.
Howard: 54:26
Not at that time. So at that time we were just learning about just normal blood pressure and the physiologic changes of blood pressure during pregnancy. The chapter on preeclamptic toxemia doesn’t mention hypertension at all, but has a great focus on how to measure protein, and this was a practical thing people were doing to screen for and try to diagnose preeclamptic toxemia. It took the next decade or so to understand what hypertension was doing and to see that it was elevated in patients with so-called toxemia. But by 1938, we had settled upon the mild and severe blood pressure ranges of preeclampsia that we’ve used for many decades after that and still use today, though we don’t use the terms mild and severe anymore.
Antonia: 55:06
So the theories about what caused toxemia changed a lot over those centuries right.
Howard: 55:13
Yeah, it wasn’t just Bright’s disease. That was really a misdiagnosis. That was really a misdiagnosis. But even when we recognize it as a distinct entity, especially eclampsia, many people thought it was due to a bacterial infection. In fact, there was a bacterium called Bacillus eclampsii that had been coined as an explanation for this. Now that bacteria ended up being Proteus vulgaris and, of course, being completely unrelated to preeclampsia. And then, eventually, the idea that the placenta built up, toxins that needed to be let out of the blood developed and, of course, this led to, at some point, bloodletting and other treatments that were ineffective and, if anything, probably made things worse.
Antonia: 55:52
I guess bloodletting is one way to reduce blood pressure maybe. But it’s a good reminder that we see the world through the information and models that we have built up in our brains to receive that information with. So when people had just discovered kidney disease, then they were on the lookout for Bright’s disease, which was just in their mind a disease of the kidneys. And then there was progress in bacteriology and so people assumed this must be a bacterium that’s causing it. And then when we’re able to measure protein in the urine, then we focused a lot on that and now we well, now we’ve been able to measure blood pressures for a while, and then that’s a huge part of our preeclampsia diagnosis right now. Maybe in the future we’ll really just be focusing on those other serum markers that we’ve been reading about.
Howard: 56:43
Simple blood tests or something. I think this history stuff is humbling to understand how we interpret the world through the information and the models that we have at the time, and I hope listeners appreciate that we still live with very limited models and understanding and knowledge. We’re just now understanding the effects of so many things on the human body that we still live with very limited models and understanding and knowledge. We’re just now understanding the effects of so many things on the human body that we didn’t know about even five or 10 years ago. And there’s a whole world that we don’t know, you think about like epigenetics and so-called dark DNA and so many environmental and multifactorial things. We know very little and it’s just a reminder not to be too cocky, but we do interpret what we see through the knowledge that we have.
Howard: 57:24
Cervical cancer, for example, for decades was thought to be due to feminine hygiene products or other things that women were exposed to environmentally. And then we discover HPV and then we thought, well, some of it was due to HPV. And then over time we discover that basically all squamous cell carcinoma of the cervix is related to HPV. And then we learn more about HPV and now we’re learning about the proteins in HPV, and there’s just so many things like that, where we spent decades with the wrong model in our minds and interpreted the evidence we saw in that framework, and then we learn, wow, that was all wrong. And here’s some underlying, greater truth. That itself may be incomplete, and so I’m humbled by these sorts of stories for that reason, and people shouldn’t think that we understand everything now either and be open to scientific advances.
Antonia: 58:16
That’s right. Well, we should probably wrap up again for today. So the Thinking About OBGYN website will have links to studies that we talked about. Remember to check out our Instagram. Send us a message or an email if you have some requests for future topics or comments or corrections, or you just want to say hi, it’s all good.
Announcer: 58:40
Thanks for listening. Find us online at thinkingaboutobgyn.com. Be sure to subscribe. Look for new episodes every two weeks.
