Episode 7.2 Cesareans for Macrosomia, Yearly Pelvic Exams, Zuranolone, and more!
In this episode, we discuss performing Cesarean for fetal weights at lower thresholds than currently recommended. Then we discuss new literature regarding utility of pelvic exams or screening asymptomatic women and early rupture of membranes after cervical ripening with a Foley bulb. Then we discuss an editorial discussing selecting the best test and hysteroscopy for miscarriage after embryo transfer. Plus, a new RCT that examines stopping oxytocin once a patient is in active labor. Finally, we answer listener questions about harms of yearly pap smears and whether we plan to use Zuranolone for treatment of postpartum depression. Buckle up!
00:01:00 Cesarean for Fetal Weight > 4000 g
00:13:20 Pelvic Exams in Asymptomatic Women
00:30:10 Early Amniotomy After Foley Bulbs
00:33:43 The Best Test: Hysteroscopy for Miscarriage
00:40:59 Stopping Oxytocin in Active Labor
00:45:00 Listener Question: Harms Of Yearly Paps
00:55:26 Listener Question: Zuranolone
Links Discussed
Shoulder dystocia: comparison of the ACOG practice bulletin with another national guideline
ACP Screening Pelvic Examinations
Ethics of Routine Pelvic Examinations
Incidence of Abnormal Pelvic Exam Findings
Early AROM vs Expectant Management
Impact of Discontinuing Oxytocin
Association Between cervical cancer screening guidelines and preterm birth
Transcript
Antonia.
Howard.
What are we thinking about on today’s episode?
Well, we’re going to answer some listener questions and review some new literature about pelvic exams, labor management, miscarriage management, among other things.
So, but more of a potpourri day.
And speaking of questions, people should send us more questions, which they can do now by following our Instagram account, which is at Thinking About Ob Gyn, and sending a message or comment on there.
But we do already have a few questions for today.
I hear, is that the new co-host, I hear?
Yes, he’s here.
He sometimes needs to eat and snuggle and do newborn things.
And he’s very awake and engaged in our conversation already.
Well, and his job mainly is to add in cute background baby noises.
So we don’t have much of a budget for sound effects.
So anything he can do, we appreciate.
Yeah, if there was any profitability to be made, I’m sure he would deserve a cut.
He gets 99% of all profits from this podcast.
Perfect.
Okay, well, let’s get started.
So what’s a thing we do without evidence?
Well, how about extensive counseling about the risk of a shoulder dystocia for a woman who may be about to go in labor or in labor, or is in labor, or even recommending a Cesarean delivery prophylactically to avoid shoulder dystocia for situations where the estimated fetal weight is just over 4,000 grams, something bigger than 4,000 grams.
I’m sure this does happen a lot, and I can remember from, at least in my training, whenever we would have turnover, if someone said, EFW over 4,000, everyone would say, oh, is there a step in the room?
Are we all ready for the shoulder dystocia?
So I’m sure this happens a lot throughout at least the US if not the world, maybe.
And I have read some of my patients’ prior op notes from their prior C-sections and other OB records, and I’ve seen this counseling just blatantly documented by their providers as if it was the standard of care to do a C-section because the EFW was 4,000, and a lot of times it was like, then the baby was 3,800 grams, and it’s absolutely against the standard of care.
So 4,000 is significant because it’s the definition of macrosomia.
So there may be clinicians who basically try to scare the patients out of their wits about everything that macrosomia has ever been associated with.
So it is associated with a higher rate of shoulder dystocia, also an increased risk of hemorrhage, Cesarean delivery, or perineal trauma, as well as future obesity and insulin resistance in that baby when they grow up, and just a ton of things statistically.
But the focus is on shoulder dystocia in this particular counseling in the setting of labor management, especially if we’re talking about should they get a C-section or not.
Yeah, and of course it’s a continuum of risk, a baby at 3,500 grams is going to have more risk than at 3,200 grams, et cetera.
So you have to draw a line somewhere about where this is appropriate.
And of course roughly 10% of all term newborns will weigh more than 5,000 grams.
It’s called macrosomia only because it’s the top 10th percentile of a normal distribution of birth weights.
And the bottom 10th percentile that we call potential fetal growth restriction, well, that’s just roughly less than 2,500 grams.
So that’s just a statistical measure.
If anything, the practical meaning of this in the newborn would maybe, do they need their blood sugars checked because they’re larger or something like that?
That’s it.
We’re just identifying the bottom and top 10 percentile when we use those terms.
So it’s just a descriptive statistic, but for this application, it’s not clinically meaningful because it doesn’t change what we do, maybe the pediatricians, but it doesn’t change what we do in practice.
Yeah, so the point is that we don’t recommend prophylactic Cesarean unless the newborn weighs at least 5,000 grams by estimation or 4,500 grams if we’re talking about a diabetic mother.
And we talked about that recommendation in a prior episode.
And even those high cutoffs, which you frankly don’t see that often, still have quite a high number needed to treat to avoid even one minor shoulder-to-socia-related birth injury, let alone something permanent or serious.
And it’s not only just overtly recommending a Cesarean that’s potentially harmful here, but even having that conversation will lead the patient down a pathway where she’s worried about her ability to have the baby vaginally.
And everyone taking care of her, as you said at shift checkout, they’ll have a lower threshold for switching to a Cesarean delivery if the labor is a little slow or if pushing is taking a little longer.
It’s unlikely that they would give the patient that has had this counseling three or four hours of pushing time because in the back of their minds, they’re worried that this baby is too big to fit out.
And the patient too will often be self-defeated by the prospect of having been counseled and told that this baby’s big and all this.
And she won’t stick it out for as long either.
Yeah, so OB providers who bring up the scary talks for four kilogram babies are basically implying that we should be doing Cesareans for the top 10% of all estimated fetal weights just based on the size alone, plus all of the other indications that we also do C-sections for.
And this is wrong.
And as a reminder too, these guidelines are already accounting for what is quite a large margin of error in ultrasound estimation of fetal weight, let alone clinical estimation.
Which is the thought process some folks have for backing down to a smaller number is, what about the margin of error?
But we discussed this previously that the clinical studies where these guidelines take their data, they use ultrasound based weights.
So it’s important to appreciate that ultrasound in the short trimester is not very accurate for determining fetal weight.
And it’s one of the many reasons why it shouldn’t be done routinely.
But we don’t need to amend the clinical guidelines or back away from the number because of that error.
They are already based upon the error prone ultrasound measurements to begin with.
So the numbers needed to treat to prevent, for example, one brachial plexus injury, they already account for the lack of accuracy in those ultrasound measurements.
So why don’t you review those guidelines again for us real quick?
Well, as you already stated them, essentially, I actually found a great article from a few years ago that was a comparison of, at the time, the ACOG Practice Bulletin about this and the Royal College of Obstetricians and Gynecologists Recommendations.
And I’ll put a link to that and these two guidelines.
Now, the ACOG guidelines since then was updated slightly with some language issues in 2017 and reaffirmed in 2020, but the substance is no different.
And both guidelines emphasize that we are not able to predict or prevent shoulder dystocia and that risk factors alone, or in some combination, are very poor predictors of shoulder dystocia, and that’s an important point.
Yeah, and I think that’s the key.
Most shoulder dystocia’s, unfortunately, happen in patients with no risk factors at all.
And in the Royal College guideline, they state that only 18% of newborns with permanent injuries had even a single risk factor for shoulder dystocia.
So it’s a scary thing, and people wanna have control over it, but unfortunately, we just don’t really have very much control.
Well, and of course, most shoulder dystocia’s happen in newborns that weigh less than 4,000 grams.
How far are you willing to go in terms of sectioning them all?
And by the way, C-section doesn’t prevent brachial plexus injury.
So a whole lot to unpack there, but it just doesn’t work the way people think they want and the control they desire isn’t available to them.
Now the ACOG bulletin does say that if you were to back down from 5,000 grams to 4,500 grams for offering prophylactic cesarean for non-diabetic mothers, that it would take 3,695 cesareans to prevent one permanent brachial plexus injury or one permanent injury and cost about 9 million excess dollars.
And of course, it says that an elective cesarean should be considered above 5,000 grams for non-diabetics and 4,500 grams for diabetics.
And notice, not recommended, but considered because there’s other things to account for there.
It’s not like you have to do that.
Yeah, so yeah, consider case by case because surely there could be a patient who has had prior successful deliveries, maybe easy deliveries without any issues of 10 or 11 pound babies, and now she’s pregnant again and has a similar estimated fetal weight.
So for that, it wouldn’t clinically make sense to say you need a C-section this time for a baby that weighs the same that you’ve previously proven.
But if they had a prior history of, I had a nine pound baby and they got stuck really bad, and now, yeah, then that would be a different story.
So account for other things as well and not just the estimated weight alone.
And if one says, well, hey, we did 3,695 extra cesareans, but we did prevent a permanent brachial plexus injury, we’ll appreciate that you probably also had an excess maternal death by doing those extra cesareans.
So it’s not like these are harmless interventions.
Now the Royal College Guideline also recommends that you consider a cesarean delivery with estimated fetal weights greater than 4,500 grams for diabetic moms.
And they actually throw shade on the ACOG recommendation for recommending non-diabetic women, cesareans at 5,000 grams.
They call that into question a little bit.
Interesting.
Yeah, they still fight the Revolutionary War a little bit.
They cite their own National Institutes for Health and Clinical Excellence, or the NISA guidelines, which states that ultrasound estimation, a fetal size for suspected large, for gestational age unborn babies, should not be undertaken in a low-risk population.
And that’s where the evidence is.
So that review article that I mentioned of these guidelines, they point out that this 5,000-gram criteria is not supported by any evidence.
But it’s interesting if you’re worried about the 5,000-gram cutoff for non-diabetics and believe that it’s an essential evidence-based practice, then you might start arguing that all patients, regardless of risk factors, should have an ultrasound at the end of their pregnancy to screen for those 5,000-gram or plus babies.
But the inaccuracy of ultrasound is so bad that you would end up harming an excessive number of women by doing that.
So the English aren’t doing them, and therefore, they don’t know about it.
Yeah, well, they seem to be making the point that how would you know the estimated fetal weight is greater than 5,000 grams if you don’t do the ultrasound?
So I guess they don’t really trust people’s clinical palpation at all, which, I mean, that’s a very rough way to estimate anything.
Well, I think if you’ve palpated it and it feels huge, do the ultrasound.
But they’re not ultrasound-ing every pregnant woman and saying, oh gosh, well, you’re 5,100 grams, let’s talk about a C-section.
And you don’t have any risk factors, you don’t have diabetes or anything.
Yeah, but it’s like their guideline where they don’t push for a section in any size non-diabetic, just based on size alone, is protective of their clinicians.
So if a British doctor delivers a baby and it’s unexpectedly 5,200 grams and they didn’t expect it to be that big and there’s a shoulder dystocia, then they’re not really held liable in the same way that probably an American obstetrician would be, because there’s this ACOG guideline that draws a little line in the sand at the 5,000.
But we should point out that ACOG also does not recommend routine third trimester ultrasounds for everyone to screen for fetal weight either.
So, and that’s like how I always figured it’s meant to be selective ultrasound for maybe an abnormally palpated weight, either too big or too small, or someone with risk factors.
So we do screen even for macrosomia for diabetic patients, for example, or certain other patients, I think advanced maternal age.
There’s a guideline that recommends you should screen them for size and things like that.
But I’ve never taken it to mean everyone should get screened.
And I know that there are some facilities in the US that do that routinely, but that’s definitely not coming from ACOG.
And a lot of things then from that ultrasound will potentially lead to harm, like incidental discovery of low fluid that leads to an unnecessary induction.
So tests are meant to be ordered in people with risk factors.
So certainly if she’s had excessive maternal weight gain or obesity or obviously diabetes or something like that, then we look.
But beyond that, we shouldn’t be looking, and then we wouldn’t know.
Okay, well, there’s a lot more stuff in those guidelines, but I think the main point that we wanted to make today was just that we should not be recommending or even discussing Cesarean for Estimatal Fetal Weights less than 5,000 grams in non-diabetics or less than 4,500 grams in diabetic mothers.
And when you introduce the shoulder to social conversation to those patients, you’re negatively impacting the patient’s birth experience for no reason because there’s no intervention available and it doesn’t change our management.
Okay, well, let’s get into some other new articles.
The January 2024 Green Journal has one new article, at least, that I know you’ve been excited about for quite some time.
Yeah, I actually saw this paper presented about a year ago at a conference by the resident who is the lead author, Nicole Norby.
And I was very excited about it then and spoke to her afterwards.
And I’m glad to see that in this month’s Green Journal, it’s the lead publication.
And there’s an accompanying editorial also that highlights its findings.
So they did a retrospective chart review of 1,121 annual gynecologic preventative visits to their clinicians and their clinic, which included attendings and residents and some nurse practitioners.
And these were patients who were aged 21 to 35.
And these patients were receiving pelvic examinations at every visit, even if they didn’t need to have a pap smear.
And I’m sure that’s common at residency training programs.
And frankly, in OGYN offices across the country, despite any evidence that it’s a useful practice.
Yeah, especially in training programs, it seems to be emphasized that the trainees do any kind of physical exam on patients in GYN, it would be pelvic exams, as often as possible for their own educational benefit, not necessarily for the patient’s benefit.
And I think we’re taught the same thing with other specialties and other exam maneuvers too.
So like listening to heart and lung sounds with the stethoscope in primary care, the idea that they would actually explicitly tell us is listen to all the normal and get used to hearing normal so that you can recognize an abnormal heart or lung sound.
So then the assumption here is that if you do as many bimanual pelvic exams as you can, basically by doing them on every single encounter, then somehow you’ll be more easily able to pick out abnormal findings, even in asymptomatic patients.
And I’m sure the same can be said for abdominal exams and surgery, neuro exams and neurology, et cetera, depending on the context.
But if that purpose is not made clear, that repetition is meant to be education for the trainee, then that person might graduate thinking that they’re supposed to keep doing these unnecessary exams because they assume that it was actually valuable for the patients.
Right.
Yeah, I think that happens with, as you said, a lot of things.
And of course, in this case, I do think there’s a big difference between listening to someone’s hearts and sounds and lung sounds and things like that on daily rounds or palpating a thyroid or something like that in clinic for your own educational benefit, but not necessarily for something the patient needs.
There’s a big difference between doing that and a pelvic examination.
We could say breast exams too, which can be embarrassing, uncomfortable, anxiety-provoking, can traumatize people who’ve had sexual traumas, things like that, and frankly, offer a false sense of reassurance to a patient about symptoms she may be having, because, hey, the exam was normal, so it must not be my pelvic organs are the problem, when the exam itself just isn’t that valuable or sensitive or specific to these findings usually.
Yeah.
And I remember when the American College of Physicians came out with their guideline in 2014, recommending against, quote, screening pelvic exams in asymptomatic, non-pregnant women.
And this was published in the Annals of Internal Medicine.
And I, at the time, was a third-year med student.
I was in clinical rotations.
And so, at my stage of training, I thought their bottom line makes a lot of sense because pelvic exams seemed so insensitive and nonspecific, I was just learning how to do them myself.
And I’d be like, what am I supposed to be feeling here?
Especially a patient, if they have a certain body habitus, or if they were awake and guarding, I’d feel like I can’t almost feel anything at all here.
And really, there would have to be something pretty significant to be clearly detectable on a bimanual exam, for example, like a big pelvic mass.
And in almost all cases, something that’s that significant, that it’s going to be detectable on a bimanual, is going to be accompanied by symptoms.
They’re not going to just walk in and feel fine, look fine, and then be like, whoa, you have a 20-centimeter fibroid uterus.
Did you know that?
And at that point, someone with symptoms would be getting a pelvic exam, not as a screening routine, but as more of a diagnostic maneuver.
And I’ve even examined plenty of patients who had symptoms and had a significant abnormality, like a large mass.
But even in those cases, because of certain reasons like large habitus or guarding, even that wasn’t really clearly detectable.
So, so much less so for subtle things in an asymptomatic patient.
Yeah, they need an ultrasound.
And obviously, body habitus is a great limiting factor to how well you can palpate anything.
But even in a thin patient, the patient, as you said, may be guarding from discomfort.
The exam itself may be, again, invasive.
It may be re-traumatizing for someone who’s had sexual trauma in their past.
I think that it’s very limited utility to these exams.
And most people are just dishonest when they do a pelvic exam on an obese patient and act like they felt anything.
They’re just frankly being dishonest.
I do think there’s a value to a so-called single-digit exam for a person with pelvic pain or pain with intercourse, where we specifically palpate different areas and isolate, try to isolate where the pain is.
That’s a different thing than what we’re talking about, which is just a screening pelvic exam in an asymptomatic woman.
Yeah, that’s not a routine pelvic exam.
It’s a targeted maneuver.
But anyway, I remember for this Annals of Internal Medicine, there was quite a bit of backlash to their statement, especially coming from Gyn oncologists, because they would send in letters to the editor and stuff or write commentaries saying that many of their cancer cases were in women who had no symptoms at all until they presented at an advanced stage.
And I anecdotally knew of many primary care physicians who didn’t seem to be comfortable performing pelvic exams.
And even now, I know of some who will literally do their patient’s entire annual visit.
Every possible preventative or screening blood test or immunization or other history, checked all the boxes, did everything except a pelvic exam, whether or not it was even indicated.
But then they would refer their patients to Gyn to get a pelvic exam.
And that’ll be like an additional Gyn annual visit.
So I thought there may have been some specialty-specific bias related to this ACP statement where the primary care folks don’t think routine pelvic exam is indicated, but then gynecologists or at least gyne oncs think it is indicated.
So now with this January, 2024 study, it’s really nice to have a study coming from within the OB-GYN specialty and being published in the Green Journal.
Yeah, and again, people want to do something.
The igeo-oncologists were, of course, were concerned that the average stage of diagnosis of say ovarian cancer is still 3C, but hey, pelvic exam doesn’t change that.
That’s the point.
We want to do something and we want to make that better, but doing these exams don’t help.
It might even deter from what we might be able to do is vis-a-vis doing an ultrasound on a patient with vague abdominal symptoms.
Imagine that she presented it and you did an exam and said, eh, it feels okay.
That’s how you get stage 3C cancers or stage 3U2 cancers, right?
So it doesn’t help.
It either helps or it doesn’t, and the science says it doesn’t.
Yeah.
So in this study, they looked at charts of 1,100 routine GYN exams, all done in asymptomatic patients to see how many times they found something valuable by doing this routine pelvic exam.
So why don’t you tell us what they found?
Yeah.
Well, among the patients with no symptoms, they did have some patients with symptoms in this study, but among those without symptoms, about 1% had at least documented in the chart from the person who did the exam some abnormality, and almost all of these were bacterial vaginosis or yeast infection.
Well, and that’s interesting too, because how can you actually clinically diagnose BV or yeast without symptoms?
For all we know, those were actually probably false discoveries that were treated unnecessarily.
If the patient didn’t have symptoms and maybe she just had normal flora or something, that showed up on the microscopy.
Yeah, remember the rate of diagnosis is not the same thing as the rate of disease.
And that goes true for things well more serious than BV or yeast infections.
People are treated for cancers and things like that that they ultimately don’t have, or for innocuous cancers that weren’t going to do anything and weren’t going to kill them.
So, right, the point of their study was to show that no meaningful discovery was made for these patients who received these exams, but on the flip side, the time taken to do that exam might have detracted from more meaningful interventions for the patient, like mental health or substance abuse counseling.
It might even be a deterrent, too, for patients who might otherwise go in for a yearly preventative visit or perhaps present to seek birth control, but they don’t want to because they’re worried about receiving an embarrassing and uncomfortable exam, particularly if they’ve been previously traumatized.
So if it deters women, for example, from receiving birth control or seeking other essential screenings or counselings, then it might actually increase the burden of disease in a population because of preventing access.
And most importantly, it just doesn’t help anybody, I think is the bottom line.
Of course, if a patient has symptoms, that’s one thing.
And even in that case, let’s say they had pelvic pain, for example, most of those patients are gonna require imaging.
They may need a physical exam as well, but if we’re being honest, ultrasound is the definitive way of assessing for adnexal and uterine structural anomalies, not bimanual pelvic exam.
And we also know that bimanual exam really serves no purpose in screening for ovarian cancer, which is what patients probably believe is happening when they get that exam.
Right.
Well, as I mentioned, there’s also this great editorial by Dr.
Lyreley from UNC Chapel Hill.
And she points out that the US Preventive Services Task Force says that there’s insufficient evidence to make a recommendation about doing these exams.
The American College of Physicians, as you pointed out, and the American Academy of Family Physicians recommend against to doing it.
And ACOG, as with breast exams and a lot of other things that our specialty is split over, like mammography that we discussed in the last episode, they recommend for a model for shared decision-making, which is, I think, a convenient way of saying there’s no evidence that this should be happening or else they would recommend for it.
But since so many of our members do this, well, we don’t want to throw them under the bus and tell them not to do it either.
Yeah, so it is the same problem with mammography or almost anything else, that shared decision-making only works if the patient is properly informed about what the value of the exam is and she’s made to understand the pros and cons.
So how would shared decision-making about a pelvic exam look?
You’d have to tell the patient firstly that there’s no evidence that it screens for anything, especially not cancer, and that doing the test is more likely to produce false positives that are too good unnecessarily than any significant finding that it’s treatment.
And frankly, any cancer that’s detected by way of routine pelvic exam would statistically be an accident, really.
That’s a great point, yeah.
And of course, like you’ve already said, the exam is uncomfortable, and for a lot of people, it’s embarrassing.
So what patient who’s been appropriately counseled in that way would choose to have a pelvic exam if she had no issues and was asymptomatic?
Maybe someone who was really anxious about something and just wants everything looked at to be very thorough.
But even then, even for that kind of patient, the pelvic exam might not be the most appropriate place to start.
It might be getting an ultrasound.
Right?
Well, I love Dr.
Lierley’s thoughts about this in this editorial.
She says in response to the question about whether we need to continue to do these or to do more studies before we abandon routine pelvic exams, she says, quote, for screening tests with no proven benefit, the answer is probably not.
Because screening tests engage otherwise healthy patients, the medical and ethical standards for performing them is higher than it is for diagnostic tests.
Even in other cases where benefits are known, harms matter greatly for any screening test.
These may include false positives and false negative test results, overdiagnosis, harmful treatment and inappropriate use of resources.
But a pelvic examination is not a screening test.
It is one of a handful of sensitive examinations for which a medical chaperone is recommended.
It’s invasive in a singular and thorough going way.
It can compound trauma in patients with histories of sexual violence.
And its routinization has unfortunately been a vehicle for abuse.
Yeah, she also points out that recent surveys indicate most women over 30 in particular are still getting these routine exams despite no professional society recommending them.
And often this is tied to routine pap smears, meaning they’re done more often than recommended even yearly.
And it’s a problem, I think, that ACOG really doesn’t take a firm enough stance on like the ACP did along with the AAFP and the USPSCF.
But maybe this study being printed in The Green Journal is the beginning of a change for that as well.
It’s not that we don’t want women to have a yearly preventative visit, and we should call it that not an exam, a preventative visit.
It’s just that breast or pelvic examinations for most of those women is not indicated.
And that time is better spent doing other things recommended by the Women’s Preventative Services Initiative, the WPSI, which ACOG does explicitly endorse, such as alcohol and substance abuse screening, anxiety and depression screening, diet and activity counseling, obesity prevention, tobacco screening and counseling, vaccination and STD screening, and periodic indicated screens for cancer, like periodic pap smears or mammograms, et cetera.
Yeah, and most women between ages 21 and 40 should likely be able to go to the gynecologist and keep all of their clothes on.
So we’ll see how much traction this gets in terms of ACOG changing their recommendation to be more forceful.
There’s a pattern of professional organizations just supporting whatever their members already do.
So for example, we talked about the radiology organization is not going to recommend against yearly mammography because a lot of their members do that and benefit greatly from those economically.
But we have to disentangle the idea that the yearly women’s visit is the same thing as a pap pelvic and breast exam.
The things that you mentioned, plus effective birth control counseling, preconception counseling, screening for personal or family history of hereditary cancer syndromes, and a few other things, domestic violence screening and mental health screening and things like that, tobacco, those things are how we can truly make a difference in the lives of young women in the context of an annual GYN exam.
And they’re not substituted for by having her unrobed in the room and having her undergo an unnecessary and meaningless exam for three minutes.
Yeah.
And I’ll mention something that maybe I shouldn’t, but one of the past presidents of ACOG in the last few years was a G1 oncologist.
And her mission for her presidency was to do exactly what you just said, to repurpose and reemphasize for the organization what the yearly exam was.
And I remember being on a conference call with her just as her office started and answering questions and answering feedback, blowback from members in the various states that were on the call, a couple of them just very upset that we would say, don’t put a speculum in women every year, and how are we going to find vulvar cancers?
And I remember one gentleman in particular did that, and I think he didn’t realize she was a G1 oncologist.
And she was absolutely ready for how many cases of vaginal cancer a year occur and how many presented from asymptomatic exams.
And her answer to him, I think, was quite humbling.
But then the pandemic happened, and her presidency became about COVID and not about this.
So we actually lost some ground in ACOG because of that.
It was a great opportunity, but then we’ve just been detracted by COVID since then.
Okay, well, let’s do a few quick articles.
Now, the first one I saw while doing my maintenance and certification stuff was one I picked out and thought was interesting.
So it’s actually from a bit ago.
It’s from May 2022 in the Gray Journal.
And this is a trial of early versus expectant artificial rupture membranes following Foley catheter ripening during induction of labor.
So basically, they took women and either performed amniotomy within an hour of the Foley catheter being expelled from the cervix, or they just did expectant management.
And they found that women with early amniotomy delivered 2.3 times faster than the women who were expectantly managed with no differences in maternal or neonatal outcomes.
Yeah, I did this article too for my maintenance.
And the timing of membrane rupture is something that sort of has gone back and forth in the literature over the past few decades or so.
And I think you can see a generational difference in practice patterns.
So many older obstetricians may believe that amniotomy is not that valuable.
It doesn’t really help with induction of labor, and you could just wait and just let them maybe spontaneously rupture when they’re at advanced dilation.
Whereas their younger counterparts might have the greater tendency to believe that it’s very valuable and rupture them as soon as you feasibly can.
And that difference probably just reflects the timing of different publications when they came out in various people’s phases of their careers.
And they’ve been concluding very different things about amniotomy depending on the publication.
So that’s the point is that there’s different conclusions out there and different practice patterns.
But the recent literature is clearly in favor of earlier amniotomy as long as the patient has a favorable cervix.
So in other words, breaking someone’s water when they’re fingertip or one centimeter, closed long high.
Firstly, that’s harder to do.
But secondly, it’s likely going to expose the patient to more risks related to prolonged membrane rupture like infection, for example, without a commensurate benefit.
So I think some other reasons providers might shy away from early AROM, so AROM before active labor, include concerns about cord prolapse and the fact that, well, this is just anecdotal, but the fact that an elective induction or even augmentation in that scenario, a patient who has intact membranes theoretically could go home if the latent labor lasts really long and they just can’t seem to get out of latent labor.
But instead of rupturing their membranes, you just say, well, let’s just stop everything.
Why don’t you come back tomorrow or the next day or something like that?
Because if you’re intact, then technically you could.
But what they’re saying here in this study, which is echoing earlier studies, is that if the cervix is ripe, then early amniotomy is safe and effective and is likely to get them past that latent phase and actually get them into active labor and get them delivered.
Right.
And later this season, we’ll do a four tips, I think, about amniotomy and address the cord prolapse issue and I’d argue that amniotomy actually reduces the risk of cord prolapse if it’s done correctly.
But as far as this is concerned, I’ll put a link to another 2018 randomized trial that found essentially the same thing.
And as you said, that’s what most of the recent trials have shown.
Amniotomy earlier on tends to shorten the active phase of labor by a couple hours with no change in other outcomes.
But yes, you don’t need to do it when they’re one or two centimeters.
They need to be three or four centimeters or in my way of thinking about it, they’re probably going to deliver in the next six to eight hours.
Yeah.
Well, let’s move on to the next thing.
So there was another good editorial.
This was in the Green Journal of November 2023 by Dr.
Isabel Green.
It was called In Search of the Best Test.
So this editorial accompanied a study in that same month’s issue that evaluated office hysteroscopy for diagnosing and for treating retained products of conception for early pregnancy loss after an IVF pregnancy.
So in that study, 21% of patients that miscarried after an embryo transfer had identified retained products during hysteroscopy, even though roughly a quarter of those patients had had normal ultrasounds and then another third had an inconclusive ultrasound.
So Dr.
Green agrees that the strategy of in-office hysteroscopy was the best test and hysteroscopy is the gold standard.
It allows for immediate treatment also.
Maybe not with all of the in-office setups, but if you have the right setup, you can also immediately treat.
And in this population, if they’re looking for definitive quick resolution so they can move on with their next IVF cycle or embryo transfer, it seems like a more efficient option just see and treat right away.
But she discusses in a fuller context what implementing that would mean.
She specifically talks about how it can be very painful to have it done in the office and how even with the really high stakes of an IVF treatment cycle, emotional, financial stakes, probably time pressure as well in a lot of cases, patients that have experienced a loss during their fertility treatments even then sometimes would still prefer to take what would be a less efficient but also less uncomfortable approach.
So, for example, start with maybe a saline ultrasound to just assess for presence of tissue that has pretty good sensitivity, especially compared to a regular ultrasound.
But obviously it can’t treat anything.
It can just show whether there’s something there or not.
And then that could be followed with a separate hysteroscopy if needed for treatment.
So on that note, I had something similar happen to me because I went through IVF and you can hear the products of that now.
And I did have an early miscarriage after a year of ovulation induction treatment.
So this wasn’t after an embryo transfer, but it was right when I was going into IVF treatments.
And it was right when I was about to start.
And so at the time, my REI gave me the choice of some kind of cavity eval.
I had never done one before.
She said either do an HSG, which is very uncomfortable and not very sensitive, or do saline ultrasound or get a hysteroscopy.
Just do one of those things.
And so with that choice, I went for the saline ultrasound.
I just did not like the idea of going through a hysteroscopy, even though I know you can see and treat right away.
And I did it.
And actually only about two weeks after my spontaneous miscarriage, and thankfully the whole process was quick, painless, and it gave a normal result.
So I think I got lucky there.
Well, even saline ultrasound can be painful too, but it sounds like you had the best case scenario for that.
Yeah, and I think this is the same idea is why we favor a two-step process for diagnosing GDM in pregnancy.
That’s just one other example.
Non-fasting one-hour GTT is much nicer than doing a fasting three-hour for everyone or even the fasting two-hour test, that the one-step process, which we know overdiagnoses GDM.
But getting a definitive answer for everyone in one go with one of the fasting tests is not quite as good as being able to spare most people from that discomfort and inconvenience by having everyone do the quicker test, even though that means that some of those people are going to end up having to do two tests instead of one, the one hour followed by the three hour.
So in this editorial, Dr.
Green also discusses the statistics involved in finding out what the best test is.
And I just, I thought it was good.
She concluded that, I’ll quote her, as we consider applying research to our practice, we should be wary of absolutes and best tests.
A uniform protocol risks compromising patient autonomy, joint decision making, and individualization of care.
Yeah, and there’s a lot to unpack there.
And it’s a good editorial that I think was thought provoking because office hysteroscopy, and to me, this is, as you said, it’s analogous for a lot of things we do.
I appreciated it.
You appreciate it on a personal level.
I appreciated it more as an analogy for a lot of what we encounter in medicine.
But in this case, office hysteroscopy will mean more money to reproductive endocrinologists and for the companies who sell these products.
And it could very easily just end up in a situation where that’s pushed down on every single patient who had a miscarriage, even beyond the world of in vitro fertilization.
You could see gynecologists doing this for everybody who’s had a miscarriage.
And I think she’s cautious about that, as she should be or as we should be.
Just because it’s marginally better by some statistical measure doesn’t necessarily translate into real world improved outcomes.
And in this case, it comes at the expense of pain, discomfort, increased healthcare costs to the system and to the individual patient, and perhaps in this case.
So I think her point is that the best test or intervention is not always the right one.
Another good example of this is amniocentesis as opposed to non-invasive prenatal screening for amniploidy.
Amnio is better, but costlier and more invasive and of course riskier.
Instead, we have to be conscious of the patient’s individual needs and desires and just of medical justice.
We still have a responsibility to spend our finite resources in the medical community in a just way.
And unfortunately, industry often subverts our medical justice with language like the best test or the best procedure or something like that.
But unfortunately, that often equals most expensive and most unjust.
Yeah, and the number needed to treat would have to factor into that.
So how many patients need the invasive, expensive procedure and at what cost to produce one additional desirable outcome?
Or like one additional accurate early diagnosis and treatment, for example.
So in this case of what she’s talking about, how many patients would end up getting DNCs with the possibility of Asherman syndrome or uterine perforation or anesthetic complications or just severe pain in the office because of an incidental finding on office-based hysteroscopy.
So in other words, in someone, let’s say, who has a normal ultrasound and she’s had resolution of her miscarriage symptoms and she’s previously had a normal uterine cavity evaluation because she already did an embryo transfer and already was evaluated before that, is it actually going to help her to get hysteroscopic confirmation that her miscarriage is resolved and not just ultrasound or saline ultrasound confirmation?
So anyway, I thought it was a good editorial and definitely worth reading.
All right, well, moving on, there was an important trial published in the December 2023 edition of The Lancet by Gérald and colleagues from France.
This was a randomized control trial with 2,459 patients at 21 maternity units in France who were randomized to having their oxytocin turned off once they got past six centimeters in active labor or have it continued until they delivered.
So this was necessarily an open label trial, and they did, of course, come up with a clever title, Stop Oxy.
I wish it was my job to come up with titles for studies.
Well, don’t worry.
When we start doing the reader question segment, we’re going to come up with some clever signature lines for the question askers like Dear Abby if you grew up reading those like I did.
Okay, yeah.
I guess that’ll fill that void in my life then.
So well, tell us what the Stop Oxy folks found.
Well, they were primarily interested in looking at neonatal morbidity.
Does it help to turn the oxytocin off?
So they looked at a pH less than 7.1 or a basic success greater than 10 or umbilical artery lactate levels, greater than 7 or 5-minute apgar scores less than 7 or need for admission to the NICU.
And they found that stopping the oxytocin at 6 centimeters made no difference in any of those outcomes that was statistically or clinically significant.
Okay, well, that’s an important finding.
I can see where people might assume that stopping oxytocin would cut down on the rates of things like tachycystole or other contraction patterns that are at least assumed to be associated with those abnormal neonatal outcomes that they looked at, but that is based on an assumption that contractions that are generated by oxytocin are, synthetic oxytocin that is, are more likely to be disruptive to maternal placental oxygen transfer than are contractions from spontaneous labor.
But that has never been demonstrated.
So we do get really conscious about pitocin use and how it might contribute to fetal heart rate abnormalities and fetal distress.
And people might start to make the false association that pitocin universally always means there’s more risk to the fetus in all patients and that no pitocin is always better than yes pitocin, which is just a faulty association.
Right, yeah.
People don’t appreciate how different the world of cetrix is because we have the ability to give IV pitocin and how many problems that solve.
You had this new baby a little early after your water broke and you weren’t in labor, so you received oxytocin to augment your labor, right?
Yeah, and my first baby, I was basically in early labor then too.
So both times I was given pitocin and had my baby the same day I was admitted, just not too many hours later.
And that wouldn’t, I really don’t think that would have happened without pitocin, so I would call it a miracle drug, really.
And a hundred years ago, you might have lingered for a day or two or three and got infected in a world with no antibiotics.
So people don’t really appreciate how far we’ve come and how important it is.
But spontaneous labor also is associated typically with stronger contractions than induced or augmented labor with oxytocin, which is also the flip of what people say on Facebook groups at least.
The truth is we’re not able to make the uterus contract as well as it does naturally when we use intravenous oxytocin.
And sure, we don’t want you to have six contractions in ten minutes, but that almost never happens.
It’s actually hard to get that to happen regardless of the dose of oxytocin.
The muscles have to, the calcium has to reset.
There’s a sequence to this.
And if it does happen, it’s something we know how to manage.
And it’s not associated with fetal or needle harm.
It’s just something that we monitor for and turn the oxytocin down or turn it off in some cases.
So it’s not bad if you have tacky systole for a while.
It just tells us we need to adjust the dose.
We have lots of false premises, I think, about neonatal acidemia and fetal heart tracings, as we’ve been discussing for a while on this podcast.
And this is just more evidence that oxytocin is not the boogie man that people have made it out to be.
Okay, well, let’s get into some of the questions from listeners.
So this is going to be the start of hopefully a monthly segment.
So please do send us your questions.
Instagram, email, smoke signal, carrier, pigeon.
It’s not Morse code because I don’t know Morse code or Braille.
But whatever works.
Do subscribe to the Instagram.
Our little assistant has worked hard on creating a page that has different content than what we’ve put on here, and it’ll be good.
Yeah, our podcast ninja.
So we may answer some questions just by directly responding, but if we think that, if we see the same question multiple times or just otherwise think this could be really interesting to a lot of listeners, we’ll try to answer them on here as well.
So I don’t know how many of our listeners remember or know about Dear Abby, but she is a legendary advice columnist for all, especially all kinds of social etiquette quandaries and just various things people write in and ask her about, and she’s been around forever.
So instead of Dear Abby, we’re going to call our segment Dear Obie.
There you go.
And just like her, we’re going to, we’re going to, like people, you can tell us who you are and where you’re writing from, but when we answer the questions publicly, we’ll make your name anonymous, we’ll make up some kind of clever signature line unless you want to make up your own, that’s fine too.
I see a lot of dad jokes in the future of this segment.
But the folks who send in questions, yeah, they should come up with their own little bylines.
If they’re funny or punny, maybe, and we’d love to use them.
Yeah.
Okay, so the first one comes from a med student.
So she says, Dear Ob, I know what the pap smear guidelines are, and I’ve heard you guys talk about those guidelines in detail.
But the preceptors I work with mostly still do yearly pap smears, and most of them will make the argument that they’re not harmful.
More screening is better.
Insurance pays for it.
The patients are happy with it.
So there’s no ethical reason to deny doing yearly pap smears.
So please give me some ammunition.
Sincerely, persistently papping people in Punxsutawney.
Well, that’s a great use of the consonants in your bioline there, Antonia.
Thank you.
And also, Groundhog Day is next week, so at least from when we’re recording.
It’s a good beginning.
Yeah, head start on that too.
But yeah, so yearly paps.
This just grinds my gears.
We talk about this a lot.
And I used to think it was some fringe thing that I only heard about from you when I was in the military health system.
It really was really unheard of.
Nobody I knew did it besides you being a civilian.
Well, I didn’t do it.
I just told you.
Well, yeah.
But sadly, now I’m out of that system.
I’m in the civilian world, and I see it in so many patients, just the majority of my patients, and I just really have to cringe.
We’ve talked about the potential harms of excessive pap smears before, but most people seem to think that the only harms are maybe psychological or financial.
So the argument is, if it’s a patient who is not psychologically affected and not financially affected directly, then why not do more cancer screenings for them?
Right.
And we’ve talked about more than just those issues in the past.
The body’s normal response to an HPV infection will provide lasting immunity if it’s allowed to proceed and develop that immunity.
So in many cases, we may actually be short-circuiting the immune system and not allowing it to tackle the HPV infection and gain immunity to it, essentially by performing a procedure like a leap or a cone before the body’s had a chance to do that.
And we shouldn’t underestimate the effect of stigmatizing sex for younger patients by screening for a cancer caused by a sexually transmitted infection and telling so many patients that they have it.
And also, there’s just no evidence, by the way, that pap smears performed more often than what we recommend in our guidelines, decreases cervical cancer morbidity or mortality.
So it just gets back to the first segment where we talked about unnecessary pelvic exams and doing those for no benefit.
Yeah, and the other thing we talked about before where the real measurable harm comes from is preterm labor and infertility.
So firstly, we’re wasting money on perhaps that are not indicated in any subsequent treatments of that, which harms other patients by taking resources away from them, perverting medical justice.
And we’re doing these uncomfortable, unnecessary exams, what’s tied to this annual routine pelvic exam that we don’t need to do.
But ultimately, when we’re performing unnecessary leaps and cones, we’re damaging the cervix and yeah, infertility or preterm birth for those patients in the future.
And there is a new article from last summer that we haven’t talked about before on here that I would highlight to answer this question.
I think I mentioned before on a previous episode that around 5,000 preterm births a year that are associated with NICU admissions, not just preterm births, but babies in the NICU, are due to the performance of unnecessary pap smears.
But this new study published in the July 2023 GMN Network was called Association Between Cervical Cancer Screening Guidelines and Preterm Delivery Among Females Aged 18 to 24.
Now, it used to be that women received pap smears even before the age of 21.
At a time, it was three years after coedarchy for a while.
And so that could be 17 or 18 or earlier.
And anyway, the authors wanted to look at the effect of the guidelines recommending cancer screening.
So this wasn’t unnecessary.
This was just a change in the guideline and then the downstream risk of preterm delivery.
And they make the argument essentially that the folks who make cervical cancer screening guidelines should actually focus more on these downstream and perhaps unintended consequences that we’re not thinking about, that the attendings that that student’s working with are not addressing.
So they were able to go back at data from the late 90s when those guidelines were different prior to 2002, and up until 2018.
And they found over 11 million women who gave birth between 96 and 2018.
And since there had been a change in how many pap smears were recommended in that age group during that time period, they were able to conclude that one additional recommended screening pap smear was associated with an increased risk of preterm birth.
In other words, they were often getting them earlier than 21.
But each additional one increased your risk.
Now, this isn’t the best study in the world or the best methodology.
There’s a lot of different things here.
And also HPV and Gardasil has come on during this timeline, so it’s a hard thing to do to calculate.
But it does add to the body of literature that shows that the more pap smears we do, the more preterm birth we cause.
And as I said, that numbers about 5,000 NICU babies a year do just to unnecessary pap smears.
Yeah, it would be one thing if those extra pap smears actually saved women’s lives from cervical cancer because then we could at least be having a discussion about the trade-off between cervical cancer mortality or morbidity versus neonatal morbidity.
But that’s not the case.
This is purely just a negative that affects those women’s future pregnancy outcomes and their babies.
So, of course, there’s also an association between extra pap smears and infertility, as we mentioned earlier, because of scarring of the cervix or destruction of the cervical glands that are necessary for normal fertility.
Imagine if ACOG, in the same way as they already do with mammography and pelvic exams, also said, we should talk about pap smears with these patients using a joint decision model and decide with the patient, do we do them yearly or how often we do them?
I think if they said that, then almost everyone would be getting yearly pap smears.
I mean, a lot of people already are, but even more people would be, because again, providers and patients just are not aware of the true risks and benefits.
I think that, yeah, and the benefits.
I think with a theme with all of these things, pelvic exam, pap smear, breast exam, mammography, et cetera, a theme with all of them is that we think they’re more valuable than the evidence actually says that they are, because they’re such a big part of our specialty or what we do.
We just assume that they’re these really important things.
I, frankly, get frustrated sometimes when people think that OBGYN is the specialty of doing pap smears that’s insulting, honestly.
Patients themselves believe then that the pap smear is more valuable than it is.
Many of my patients believe that it’s a screening for ovarian cancer or uterine cancer or vaginal cancer.
There are all sorts of things that it’s not a screening test for, and doctors, as I said, believe it’s more valuable because they do.
It is such a priority, and they spend so much time doing it, and they want to imagine that it’s an incredibly important thing that they do.
And it is a valuable thing.
We’ve done tremendous work in this country of cutting down cervical cancer mortality compared to other countries in the world, but it’s like everything needs to be done at the right dose, at the right time, at the right interval.
Too much of anything is bad.
Well, hopefully that medical student can make a better argument with her attendings, but they probably don’t want to hear that they’re hurting patients with extra pap smears, especially not from their med student.
Their medical student, right, yeah.
But guidelines exist for a reason, and it’s fairly arrogant of any physician to think that violating those guidelines on a regular basis could be a good thing.
And most young patients historically have been exposed to the HPV virus.
Hopefully, that’s changing with the vaccination programs, but historically 80 to 90% of young sexually active women will have HPV, and we just don’t need to know about it because we need to give them a chance to have a healthy, normal immune response that’s going to clear it in almost all cases.
People really should convert their enthusiasm for doing pap smears, especially pap smears under age 21, into an enthusiasm for vaccinating them against HPV.
Yeah, that would be way more effective at cutting down on cancer.
Yeah, absolutely.
How do you know the question asked her, by the way, was a her?
You said her.
Well, I assumed because I saw the name, and I assumed it was a very female name.
Well, I have a question too.
So Dear Ob, I don’t know how we’re going to do this.
Dear Ob, I haven’t heard you guys talk about Zuranolone yet.
We had a lunch provided by the drug rep in our residency program, and they told us it was the best thing since sliced bread.
What do you all think?
Sincerely, postpartum and depressed in Seattle.
I don’t think your signature line was as good as mine.
Well, I’m not as creative as you are.
It’s a competition, so we’ll see.
We’ll see.
The listeners can beat us.
But we did read a lot over the summer about Zuranolone, and for postpartum depression, there was a phase three trial that randomized women to this new medication versus placebo for 14 days.
And then they measured changes in the Hamilton Depression rating scale the next day, and for a few days after that, and at two weeks, et cetera.
And they found that the drug lowered the Hamilton Depression rating scale by an average of four points compared to placebo, I think, at two weeks.
Okay.
So for any listeners who don’t know, this new drug is a neuroactive steroid GABA A receptor positive modulator, and they did two FDA trials as required by the FDA to show that it was better than placebo at lowering the score on this depression scale.
And this isn’t the one that we typically use.
That’s 10 questions.
This is more questions.
They didn’t show that it decreased risks of suicide or hospitalization related to severe depression or of psychosis or any other measure of depression that we might think of as significant or dangerous.
It just showed a decrease in this score of this Hamilton scale.
So have you met a drug rep for this yet?
And do you see any potential utility for this drug?
Well, this is essentially an oral form of Brexanolone, which if you recall was very expensive and required a 60-hour in-hospital IV infusion and consequently was incredibly expensive.
So just completely impractical in the context of a postpartum patient who likely has a newborn to take care of.
And I didn’t use that, and I don’t think I’ll be using this either.
For one thing, a 14-day course of this oral medication is $16,000.
So I also don’t think that the company selling it actually cares about postpartum women and their depression or else it would be a few hundred bucks at the most.
But beyond that, this gets to the core of how we decide as a general principle to use a new drug.
If we knew that this medication actually decreased by a statistically significant amount, things like suicide or other serious and expensive postpartum sequelae of post-depression, then we might be able to justify that cost because you’re preventing a hospitalization or something like that.
But right now, all we’re seeing is four points less on a Hamilton depression scale.
But more importantly, what we don’t have is a comparator trial.
And this is the mistake that’s always made with new drugs as they’re brought to market.
What other medications can lead to a four-point reduction on a depression scale and do that within 14 days of use or other interventions, non-medical interventions perhaps?
I’ll bet you that trazodone can do that, and a whole month supply of trazodone is $4.
I’ll also bet you that a lot of other medications would be able to do that.
So we don’t adopt a new medication until we see that A, it’s better than placebo and safe, but B, that it’s better than the currently available medications.
And of course, the company that makes the medications, they don’t do comparator trials that often, unless they know they’re going to win.
Nor did they look at real outcomes that would matter that we’re all worried about, like postpartum psychosis, depression, suicide, requiring hospitalization, things like that, and things that are expensive, psychotic features, etc.
They just looked at this Hamilton Depression Scale.
Yeah, to try to give some kind of benefit of the doubt, I think the only things that seem unique about this are the short course, like the 14-day course, and the fact that it supposedly works that quickly compared to, well, not Trazadone, but maybe Zoloft.
And then I assume, before I read, that this is really tailored to postpartum women.
And of course, the reps will come in and say, this is the only FDA-approved drug for postpartum depression.
And yes, that’s technically true, but if you look into it, that’s really just irrelevant, like Dicleg is for nausea, whereas you could just use off-label things for much cheaper.
But there are a lot of other things.
Now, if you extend this to a month, you’re spending $32,000 a month.
There’s a lot of other things that $32,000 a month could buy that may make that patient feel better by at least four points on the Hamilton Depression Scale instead of this drug.
So this definitely feels a bit like robbery.
I’ll put a link to New York Times article that covers the release of this medication, but I have seen stuff about it on social media, basically casting it as some kind of long overdue innovation that’s finally recognizing postpartum depression as something that deserves special recognition and treatment.
But besides the lack of efficacy data against usual care, so maybe counseling or other SSRIs, for example, or trazodone, there is nothing about it that makes it tailored to a postpartum patient.
And specifically, it’s not recommended to breastfeed while using it because they don’t have safety data on lactation or effects on the infants.
So that is a huge mark against it, firstly.
And there’s actually concern about addictive potential because of its mechanism of action on GABA receptors, which also is not a good thing at all.
And they don’t recommend it for patients who have a history of severe mental health problems or people who are most at risk for suicidal behaviors or any behaviors that would lead to inpatient treatment.
So really, if you think about it, this isn’t even a treatment for anything except postpartum blues, given that 14-day treatment duration and the mild severity of symptoms that their FDA approved for.
And appreciate that the social media posts and talking points you see are promoted by the company, right?
Yeah.
A marketing team has come up with this, and let’s try to not fall victim to it.
But I’ll put a link to this Hamilton Depression Rating Scale tool that they use, and you can look at that and quickly see how minimal a change four points is.
There’s 17 questions, and you get 0 to 4 points, potentially for your answer to each question.
So you could improve your score by 14 points or so pretty easily.
If you went from moderate to mild complaints of GI disturbances or other somatic symptoms, you could lose a point or two.
If you went from unable to fall asleep to only waking up often, but being able to go back to sleep, you could lose a point.
And I bring that one up because this is a sedative medication.
You would lose a point if you went from being so agitated that you can’t sit still to merely playing constantly with your hands and hair, or lose two points if you went down to mere fidgetiness.
You would lose a point if you went from expressing your fears without questioning to merely displaying an apprehensive attitude in your face or speech.
So a 4-point decline in that scale is perhaps not even clinically meaningful, and is likely just associated with the sedative properties of the drug, which you could accomplish with a $4 antihistamine, let alone something like Trazodone, to improve sleep quality and depression in a more quick way.
And I’ll put a link to a study that looked at the reduction in the same Hamilton Depression score with Trazodone and Zoloft, that actually was a comparative trial between the two from a few years ago.
And they looked in the same kind of timeline, so they have 14-day initiation data in both of those drugs, Zoloft and Trazodone led to about a six or seven point reduction at day 14 in the same scoring system.
And both are $4 a month.
There you have it.
So hopefully, health care systems don’t waste money on this.
And let’s also hope that maybe this company will just go ahead and sell it for a reasonable price at some point in the future, because maybe it could work for someone that has failed other medications, and it might help them, but it wouldn’t help them if it’s going to rob them of $16,000 for two weeks.
Let’s wrap up.
The Thinking About Ob Gyn website will have links to all the stuff we said we would link to.
And we’ll be back in a couple weeks.
Please send us your questions and check out our Instagram.
Thanks for listening.
Find us online at thinkingaboutobgyn.com.
Be sure to subscribe, look for new episodes every two weeks.
