Affairs and Medical Education. We're so glad that you're here for today's webinar on Medication Management for Early Pregnancy Loss. As questions come up throughout the presentation today, you can add them to the Q&A box on the Zoom toolbar, and we'll have an opportunity for live Q&A at the end of today's presentation. The webinar is eligible for one CME credit, and to claim that credit, please use the QR code that we'll show at the end of the presentation. The recording will be made available on Society Education in the coming days, in case you want to reference it or suggest it for others to take for CME credit as well. And with that, I'm pleased to introduce our speakers for today's webinar, Dr. Jamie Trevino, Dr. Jessica Tarleton, and Dr. Lindsay Benson. Dr. Trevino is a board-certified obstetrician-gynecologist who completed her fellowship in complex family planning at Washington University in St. Louis, and she currently provides care in Southern Illinois. Dr. Tarleton is a board-certified obstetrician-gynecologist and complex family planning subspecialist, and she is also an OB-GYN hospitalist and abortion care provider in South Carolina. And Dr. Benson is an OB-GYN physician researcher and complex family planning subspecialist at the University of Washington in Seattle, where she provides clinical family planning care at the University of Washington and as an abortion provider at Cedar Rivers Clinics. Dr. Benson's research focuses on the management of early pregnancy loss in the emergency department and the impact of abortion restrictions on early pregnancy care. And with that, it's my pleasure to hand it off to our first speaker, Dr. Trevino. Thank you, Robin, for the introduction. We're really excited to have you all here today to talk about our recommendations for medication management of early pregnancy loss, and we'll be reviewing the evidence and also the recommendations from this clinical guidance. And next slide, please. We have no financial disclosures. Next slide. And we will be discussing our learning objectives. So, after this presentation, you should be able to describe the most evidence-based medication management for management of early pregnancy loss, discuss various patient-centered ways to diagnose early pregnancy loss and confirm completed treatment, and access resources to improve access to medication management of early pregnancy loss. Next slide. And we also wanted to discuss the need for guidance. So, the Society of Family Planning Clinical Affairs Committee takes suggestions from members for the need for updated guidance and prioritizes them, and then an author team is chosen and tasked with addressing the topic areas suggested by the Clinical Affairs Committee. We, with our guidance, wanted to uplift the preferences of mifepristone and misoprostol for first line of medication management of early pregnancy loss. We also wanted to review the evidence for alternatives to ultrasound for follow-up. We want to review the evidence for the role of telemedicine in early pregnancy loss diagnosis, treatment, management, and follow-up, and consider patient-centeredness of options and access and health equity when it comes to managing early pregnancy loss. We also wanted to review other updates, like the RH guidance, as well. Next slide. And the Society of Family Planning uses a modified grade framework to rate the level of evidence and strength of the recommendation for each recommendation. So, we have this table here, so you can refer to it as you see recommendations throughout the presentation. Next slide. So, for our guidance, we want to be mindful that there's no consensus on definition of early pregnancy loss in the literature, which can make it challenging to compare studies and management recommendations. Early pregnancy loss is a broad term that often refers to an intrauterine pregnancy with findings that suggest that the pregnancy may not or will not progress, but it can also include pregnancy loss in progress, like a gestational sac in the lower endometrial cavity or in the endocervical canal, or complete passage of the gestational sac with or without retained tissue. So, for the scope of this guidance, we provide recommendations for medication management of early pregnancy loss in which the complete passage of the gestational sac has not yet occurred, and we don't specifically address incomplete early pregnancy loss, like retained products of conception or when the gestational sac has passed prior to healthcare evaluation, although many of the treatment approaches that we discuss in this guidance can be used in these clinical scenarios. We provide recommendations for up to 13 weeks and six days of gestation, and given the landscape of abortion access in the U.S., we want to include considerations in areas with abortion restrictions, which impact the access of medications like mifepristone and misoprostol. Next slide. So, to review some background information, early pregnancy loss is a common occurrence and affects nearly 1 million pregnancy-capable people each year in the United States, and an estimated 15 to 20 percent of pregnancies end in early pregnancy loss. Once diagnosed, a patient-centered approach should be used to counsel patients on their treatment options, including expectant management, procedural management with uterine aspiration, or medication management. All methods of early pregnancy loss have been found to be safe, affected, and accepted by patients, and standard gynecologic and emergency care should include access to prompt and active management of early pregnancy loss when indicated and desired by the patient. Medication management may be preferred by patients who prioritize control, predictability, privacy, or who just want to avoid a procedure, and evidence shows that mifepristone followed by misoprostol is the most efficacious and most cost-effective medication management regimen. Next slide. Based on that evidence, we recommend that patients experiencing early pregnancy loss have equal access to all available treatment options, including expectant, medication, and procedural management when urgent treatment is not necessary. Clinicians caring for pregnant people should be familiar with the diagnostic considerations and patient-centered approaches to the management of early pregnancy loss, as well as systemic and legal barriers that restrict access to safe and effective care. Next slide, please. There's many barriers to equitable access to medication management, and in settings where mifepristone is available, patients still face barriers to accessing medication management, including systemic racism, institutional limitations, costs, clinician practices, abortion-related stigma, and the politicization of reproductive health care. Evidence shows that patients may not be offered all management options, depending on the clinical setting. For example, there was a recent observational study of insurance claims of people seeking early pregnancy loss care, and it found that patients presenting in the emergency department were less likely to receive medication management than people presenting to outpatient clinics, and they were less likely to receive active management. Access to mifepristone remains inequitable due to the politicization of reproductive health care, and despite the excellent safety profile, the use of mifepristone has been regulated by the FDA REMS, or Risk Evaluation and Mitigation Strategies, since the FDA approved it in 2000. Even in states where abortion is legal, the availability of mifepristone depends on clinicians and retailers being able and willing to complete the REMS certification and feeling confident in their knowledge and special conditions placed on mifepristone use. Mifepristone mesoprostol regimen remains underutilized for early pregnancy loss, and in a study of insurance claims of adults in the U.S. receiving medication management of early pregnancy loss in 2020, 2.5% of patients received mifepristone plus mesoprostol, while 97.5% received mesoprostol alone. Next slide, please. And so, due to these disparities, we recommend institutions and clinicians make thorough efforts to obtain and maintain access to mifepristone in clinical settings where patients receive early pregnancy loss care. Understanding the disparities in pregnancy loss care is an essential step towards providing equitable patient-centered care to all patients experiencing early pregnancy loss, and it allows clinicians, institutions, and policymakers to create initiatives to improve early pregnancy care. Next slide. Next, I'm going to address the diagnosis of early pregnancy loss, or EPO. We recommend that a patient-centered approach that uses shared decision-making to diagnose EPO through ultrasonography, serial quantitative HCG measurements, or symptoms, depending on the patient's desire for definitive diagnosis of EPO. There are multiple points here that I want to highlight. We want to highlight taking into account patients' priorities and desires, alternatives to ultrasound, and I'm going to touch upon alternatives to the Society of Radiologists and Ultrasound Criteria that are commonly used. First, what might prioritizing a patient's desires look like in practice? Let's say we have two identical patients who should be seven weeks estimated gestational duration by their last menstrual period. They both have an identical ultrasound, as you see here, showing a fetal pole measuring 5.5 millimeters without any cardiac activity. We counsel her that this is suggestive of an early pregnancy loss. One patient may want confirmation, something to solidify that this pregnancy is definitively not viable before doing any intervention or treatment, while another patient may have, for example, stopped feeling symptoms of pregnancy and feel very certain that she no longer has a viable pregnancy, and she might want the quickest available resolution to her pregnancy so that she can move on and cope with her loss and perhaps make plans to pursue her next pregnancy. Of course, these examples assume a desired pregnancy, but we also encounter patients for whom the pregnancy was not planned in the first place, and for whom definitive diagnosis is certainly not a priority before desiring intervention. Also, let's expand on our traditional methods of diagnosing early pregnancy loss, with the traditional measure being ultrasonography on one or more occasions that meet one of the definitive criteria for EPO. Let's discuss the same patient. She's seven weeks by last menstrual period with a crown rump length of 5.5 and no fetal cardiac activity. Today, this patient prefers an absolutely definitive diagnosis, so according to your usual practice, you recommend that she return for another ultrasound in one to two weeks. The patient is highly distraught and wonders if there is another faster way to know with absolute certainty without waiting two weeks. In this case, despite it not being usual practice for most people, you might consider drawing a beta-HCG that day and repeating it in 48 or 72 hours, and the trend may tell you with certainty within a much shorter period of time without requiring the patient to wait for a long period. Likewise, if the same patient went home without intervention and called your office the next day reporting that her nausea and breast tenderness have resolved and perhaps she started spotting, could you prescribe medications for her to take without coming back to the office? And of course, we suggest that this can be done based on the symptoms and the ultrasound that are suggestive of an early pregnancy loss. I do want to be clear here that we are not at this time suggesting any particular no-touch or telemedicine-only approach to diagnosis or treatment of EPL because the data don't support any one intervention, but we do encourage further research and discussion on this topic and hope that we can generate new ideas from this document and presentation. And I am sure that most of you recognize this table, the Guidelines for Transvaginal Ultrasonographic Diagnosis of Pregnancy Failure in a Woman with an Intrauterine Pregnancy of Uncertain Viability, as it is replicated in ACOG Practice Bulletin on Treatment of Early Pregnancy Loss and often cited, but we would like at this time to caution you against adhering strictly to these criteria. As you can see from the bottom, this paper, or the paper from which these recommendations come, was published by the Society of Radiologists and Ultrasounds, and with some possible exceptions, radiologists are rarely talking with our patients, assessing their symptoms, and discussing their pregnancy intentions. The paper from which it comes also explicitly states that the purpose of the criteria are to rule out a viable pregnancy with 100% certainty, so as not to intervene on a possible viable pregnancy, no matter how unlikely. Furthermore, the guidelines suggest diagnosing EPL when there is a crown-rump length of seven millimeters and no embryonic cardiac motion, despite their own data demonstrating a 5.3 millimeter threshold gave 100% diagnosis, or diagnostic certainty. And similarly, they suggest that an empty gestational sac with a mean sac diameter of 25 millimeters was the diagnostic threshold for EPL, despite their data showing that 21 millimeters was adequate for diagnostic certainty. So these criteria seem to prioritize maintaining a potentially ongoing pregnancy without consideration of the clinical context or patient preference, and a strict adherence to the criteria could lead to a delay in diagnosis by up to two weeks in some cases to achieve 100% diagnostic certainty of these particular criteria, without regard for the needs of the pregnant person. So this is a very tiny table to reference, and we purposely did not put it into our paper so that it was not mistaken for actual recommendations, because I think it's important that we understand how these recommendations and guidelines were generated so that we can consider clinging maybe a little bit less tightly to them. As reproductive health and pregnancy specialists, we have the ability to gather additional data like symptoms, labs, and patient preferences, and as the authors of this document, we advocate for doing this when deciding how to move forward with a likely pregnancy loss. Of course, we must do this taking into account the legal setting in which you're practicing and your own legal risk tolerance, because many individuals and organizations in abortion restrictive states, like my own in South Carolina, could be concerned about the implications of abortion restrictions on diagnosing early pregnancy loss. But in the absence of any particular legislation defining early pregnancy loss or miscarriage, we continue to advocate for a multifactorial approach to diagnosis, just as we do in any other medical scenario. So once we've diagnosed EPO, what's the optimal time to initiate medication management? Again, we recommend a shared decision-making approach for management decisions. We suggest that active management with medications or procedure be reasonably, properly available at the time of diagnosis of EPO and any time during expected management if the patient has made a decision to wait. Research shows that many people may choose expected management because they need time to process the diagnosis or consider their options before initiating treatment, while others may value active management with medication or procedure for control and predictability over the process, as well as quicker return to personal and professional obligations. We recommend that clinicians do not require patients to undergo a period of expected management before offering medication or procedural management, although patients may prefer expected management for some of the reasons that I stated above. In our review of the literature, we found that expected management of EPL for six to eight weeks is safe, but limited data explain the risk of complications of prolonged retention of a gestational SAC after EPL is diagnosed beyond eight weeks. But while there is increasing risk of DIC with retention of a second or third trimester of fetal loss, there is not any evidence that the risk of coagulopathy or infection increases with increasing time from a first trimester EPL diagnosis. Next we address if RH testing and RH immunoglobulin administration in RH negative patients are required during medication management of EPL. And we suggest against RH testing and RH immunoglobulin administration before 12 weeks of gestation for patients undergoing medication management of EPL. In doing this, we reaffirm the Society of Family Planning Committee consensus on RH testing in early pregnancy. And these recommendations are also in line with those from ACOG, the National Abortion Federation, the World Health Organization, and Planned Parenthood Federation of America. We do continue to recommend RH immunoglobulin administration of 100 micrograms for RH negative patients with pregnancies from 13 to 18 weeks of gestation. We in this document did decide not to do an extensive research or extensive review of the literature for this because of the recent committee consensus by Dr. Horvath and others that you can see here. Next we're going to talk about the medications that are safe and effective for medication management of EPL. And as we kind of foreshadowed, we recommend a combined regimen of mifepristone and mesoprostol as preference over mesoprostol alone for the medication management of early pregnancy loss. In our review of the evidence, we have an abundance of data from observational studies, meta-analyses, and now a few randomized controlled trials that demonstrate the preference of a combined regimen with mifepristone and mesoprostol. When used together, we suggest the use of mifepristone 200 milligrams orally followed seven to 48 hours later by mesoprostol 800 micrograms vaginally or buccally when used to treat early pregnancy loss. 400 milligrams of mifepristone or 600 milligrams of mifepristone have not been shown to be more effective than 200 milligrams. Lower doses of mesoprostol, less than 800 micrograms, have been shown to be inferior. And sublingual and oral administration are also safe and effective but may have greater incidence of GI side effects, which is why they're not our top recommendation. Now, I know if I have to say this slide is busy, then I shouldn't be showing it. But I wanted to highlight the four randomized controlled trials that do demonstrate the preference of a combination of mifepristone and mesoprostol to mesoprostol alone. First, to demonstrate the amount of evidence that we've accumulated, even in the past several years, about this combined regimen. It's also interesting to look at the variations in gestational duration inclusion criteria and the variety of outcome measures that are used. And in looking at, reviewing all the evidence, all of these variations of protocol did make comparison between studies very difficult in terms of details like route of administration of the mesoprostol or what should be used as a primary outcome measure. But we can see in looking at these four studies that clearly regardless of the inclusion criteria or the primary outcome is used, mifepristone and mesoprostol is superior to the mesoprostol alone. In the final study below the Stockheim study, there was not a statistically significant difference but a trend towards the combination regimen. When mifepristone is not available and mesoprostol is used alone, we recommend mesoprostol in two or more doses of 600 to 800 micrograms sublingually at intervals of at least three hours when used alone. The most important parts of this recommendation are higher doses of mesoprostol, 600 to 800 micrograms are definitely superior to doses of 200 or 400 micrograms and planned doses of two doses or more. There is a variety of evidence of efficacy for different timing of the two doses of mesoprostol but we recommend reading at least three hours and up to 24 hours has been shown to be effective. There's also excellent evidence for vaginal and sublingual administration, I'm sorry, sublingual and oral administration but given, I'm sorry, backing up. There's excellent evidence for sublingual and vaginal as we suggest but buccal administration is likely also effective given its use in first trimester abortion. I wanted to briefly touch upon some of the other combination regimens that may work for medication management of EPL. There is some evidence for the use of letrozole with mesoprostol from a Chinese study but it's too early to recommend this as one of the first line regimens. Methotrexate and mesoprostol have been shown to be effective for first trimester abortion but there are not studies that evaluate its use in early pregnancy loss. And it's important to continue studying the alternatives to mifepristone in combination with mesoprostol. Given mifepristone's, the barriers legal and otherwise to mifepristone use which could become worse in the future or could become better if things go well. Mifepristone can also be used with other prostaglandin analogs although I expect that scenarios in which these agents are more available than mesoprostol are pretty limited. All right, hi everybody. The next topic we're going to move on to is what is the recommended pain management approach during medication management for early pregnancy loss? So for pain management, data specific to EPL is really limited. There was a secondary analysis of data from the Schreiber RCT that was shown on a prior slide comparing mify plus meso to mesoprostol alone that showed that the mifepristone plus mesoprostol combination group experienced potentially more severe pain but also shorter duration of pain than the mesoprostol alone group. Data assessing different approaches to pain management in the setting of medication management of EPL, however, is definitely lacking. There is certainly more research on pain management for medication abortion though. So we did extrapolate some of our review and recommendations from the abortion literature. So there was a Cochran review of pain relief with first trimester medication abortion with mifepristone plus mesoprostol that did find that ibuprofen was effective in reducing pain while no difference in pain scores was seen with a one-time dose of pregabalin. I will add that the majority of outcomes included in that Cochran review on medication abortion pain management did have low certainty of evidence due to low sample sizes and high amounts of biases in these studies. Additionally, there was an RCT published in 2018 that compared pregabalin versus placebo for medication abortion with mifepristone and meso that found that while pregabalin did not decrease pain versus placebo, it did reduce the need to co-administer ibuprofen or narcotics. A couple of other studies we cited were an RCT from 2019 that looked at 10 milligrams of oxycodone versus placebo in addition to ibuprofen for medication abortion and found no significant difference in pain. And additionally, an RCT looking at dronabinol, a synthetic cannabinoid, found that it did not reduce maximum pain scores when compared with placebo. So ultimately where we landed with our recommendations was to suggest ibuprofen 800 milligrams orally for pain control in medication management of EPL. The use of other NSAIDs and opioids in this setting is not supported by the literature but may be reasonable on an individual basis. So of course, if you're seeing a patient who wants medication management of EPL and they have maybe had a very painful prior experience with a similar situation, is it reasonable to consider opioids in that setting? Absolutely. So individual judgment on an individual basis is of course always reasonable. And this is also an area where more research is needed to develop alternative pain management strategies for both EPL and medication abortion. Okay, now we can go to the next slide, which is covering, if you click to the next one, the optimal approaches to confirm completed EPL after medication management. So we reviewed a variety of approaches including in-person and virtual evaluation and really found that no one approach will work for all patients. So our recommendation is that clinicians offer all patients confirmation of completed EPL but that in-person evaluation should not be required. So for patients wanting or needing in-person follow-up after medication management of an EPL, these visits commonly take place one to two weeks later. In this setting, the goal of an ultrasound done at an in-person visit should be to confirm the passage or absence of a gestational sac. There's no need to demonstrate a completely empty uterine cavity or use any specific cutoff for endometrial thickness. Again, here we drew on some data from the medication abortion literature. We cited a large pooled analysis that found there was no endometrial thickness threshold that had a positive predictive value greater than 25% for needing subsequent procedural intervention. We did find one randomized trial specific to early pregnancy loss that found no clear association between endometrial thickness and need for procedural intervention. So thus we made this second recommendation shown here on this slide against using endometrial thickness alone as a criterion for recommending additional intervention after medication management of EPL. In terms of the virtual follow-up options, we reviewed the literature on telemedicine follow-up after medication abortion, which typically includes options like a telephone assessment of symptoms at one week and or home urine HCG testing at four weeks. Everyone on this webinar is probably well aware that there is great evidence regarding the accuracy of patient and clinician assessment that a medication abortion has been successful. However, data regarding the ability of patients and clinicians to predict successful treatment of EPL are limited and the probability of a correct assessment is likely lower than in the medication abortion literature given the less predictable trajectory of symptoms following EPL compared with medication abortion. In general, if either the patient or clinician feels that management may not be complete or there are other concerns, in that case, in-person evaluation should be offered. We also reviewed testing of HCG levels following EPL. Unlike the predictable serum HCG trends seen following medication abortion, there is significantly more variability seen in serum HCG levels following EPL. In a planned secondary analysis of an RCT comparing EPL management with mifepristone plus mesoprostol to mesoprostol alone, EPL treatment success was associated with a greater decline in serum quantitative HCG levels, but there was no threshold for percentage decrease that predicted successful treatment. While there is no clear consensus regarding absolute HCG levels or threshold for change in HCG levels that confirms successful medication management, a substantial decrease can certainly suggest successful completion of EPL. Similarly, thresholds for expected time until a negative urine HCG test are not clearly defined in the setting of medication management of EPL either. So this is also an area where further investigation is needed. And any use of urine HCG tests to monitor completion of EPL should also consider the patient's clinical course and symptoms. We also emphasized in our guidelines that any follow-up should be patient-centered with follow-up visits offered but not required and that treatment should not be withheld on account of a patient's ability to follow up in-person or complete specific subsequent testing. Now we can go to the next slide. Additionally, in our document, we did include some resources for improving access to EPL medication. A few of them are shown here on the slide. So one is the Pregnancy Early Access Center Peace Clinic Toolkit from UPenn with the website shown there. Another is the TEAM Project, Training, Education, and Advocacy in Miscarriage Management. This is an interdisciplinary program started by Sarah Prager at University of Washington that provides in-person and virtual trainings for folks wanting to improve evidence-based early pregnancy loss treatment in emergency departments or elsewhere at their institutions. And then we've also cited the Reproductive Health Access Project as a great resource as well. Next slide. So throughout this talk, we have mentioned repeatedly areas for recommendations for further research. So there are lots of places where we identified data gaps either in general or places where we were extrapolating data from the medication abortion literature and then places where we were maybe just really in a data-free zone. So we've listed in this document some ideas for recommendations for future research. I bet everybody on this webinar could probably think of an additional idea not listed here that they think should be explored further. But a couple of the ones we reviewed were applicability of no-test protocols for the EPL setting, telemedicine approaches for EPL, more studies comparing alternatives to mifepristone, timing of mifepristone with misoprostol for best efficacy and patient satisfaction, getting a better understanding of disparities in EPL care and barriers to accessing comprehensive, high-quality medication management of EPL and then also optimal pain management regimens. You can go to the next slide. So we just wanted to acknowledge our additional co-author, Dr. Moyetti, who could not be present today, as well as the reviewers and the Society of Family Planning and Robin and Margaret. And thank all of you as well for listening. And we would love to take any questions from the audience. Thank you so much. Thank you. We do have a question in the chat. So first I'll say this is for folks who are hoping to gain CME credits for today's webinar. Yep, link is just in the chat and you can use the QR code that's here on the screen as well. We do have a question here about recommendations for any patient facing resources that the authors may recommend, in particular for EPL diagnosis, as well as management. I think earlier in the slides, the RHAP website, it's primarily geared towards implementation of reproductive health care in a primary care setting, but they have really excellent patient facing materials to share with patients. That's one particular resource I can think of. Anything else you guys? I also second the reproductive health access project. I really like their resources. I just I think I just added the link to specifically their miscarriage resources into the chat as well. Fantastic. We have another question here. What do you recommend as best follow up if in-person evaluation is not required, but no HCG trends have been previously well established? I think that that is a data free zone. So, you know, to be adherent to the goals of the recommendations, we wanted to review the evidence for what has been shown to be safe and effective, but we don't necessarily know or have data on alternative methods of follow up. So I know it's kind of a wishy washy answer, but truly, I think, you know, combining your expertise along with the the desires of the patient, you know, while not neat and cut and dry, will probably give your patient the best experience in patient centered care. I agree. I think it really depends on the specific situation a lot of time. I mean, perhaps down the road in the future, we'll have more data to guide us on HCG trends. But in the meantime, I think a lot of it depends on how much certainty the patient needs in that moment of the trajectory of how the resolution of their early pregnancy loss is going. So I think that needs to be shared decision making between the clinician and the patient of sort of how best to follow their progress. I'll also add, and I believe it mentioned in our guidance as well, I like to recommend a pregnancy test at four to five weeks after taking the medication so that they don't necessarily need an in-person visit with an ultrasound. Or if you don't know their HCG trends before and after, you can use that pregnancy test around four to five weeks at home. Thank you all. There is an additional question here about sort of how many doses of misoprostol after Mifepristone. Do you offer multiple doses similar to medication abortion? So how many doses are you generally giving folks if they're using a combination Mifepristone and misoprostol regimen? Well, again, being kind of a stickler for the data, I will have to say that there's no evidence for multiple doses. You know, kind of looking at all things considered, Mifepristone plus one dose of 800 micrograms of misoprostol is successful in probably about 85% of cases. So it would be reasonable to prescribe an additional dose of misoprostol to kind of reduce patient barriers to getting additional doses. But in most cases that should not be necessary. Thank you. Someone is asking, may also be a data-free zone, but there may, I mean, perhaps, Lindsay, with some of your research focus, someone is asking if there are data about the benefits of incorporating Mifepristone and misoprostol for early pregnancy loss into settings in an emergency department. Yes. So if the question is whether this should be incorporated into ED settings, broadly, I would say absolutely. So I think regardless of where somebody presents for care, they should have access to all options for management of early pregnancy loss based on their preference. So medication, procedural, or expectant management. And ideally, if they are choosing medication management, they should have access to Mifepristone plus misoprostol when available, as opposed to misoprostol alone. That's certainly not available in all settings. And we have good data to show that patients are less likely to get active management when they initially present to an emergency department, as opposed to outpatient clinic setting, and that among patients who get medication management, if they present to an ED, they're less likely to get Mifepristone in combination with misoprostol than if maybe they present to other settings. So our hope is that with this guidance additionally encouraging folks to try to obtain access to Mifepristone at their institutions, that we can encourage that in more settings, including in the emergency department setting. I think there's a lot of barriers to that, which we can certainly delve into more if there's follow up questions about that. I just wanted to add, with my current experience as a hospitalist, I take care of a lot of patients in the emergency department who are having early pregnancy complications, because many of the private practice doctors that they may see don't start care, don't recommend they come in, or sometimes in some cases won't schedule an appointment with them. Until they're like eight or nine weeks pregnant. And so patients do need access to high quality care, even before they have been able to establish care with a certain practice. So anywhere we can improve access to all management options would be best for patients. Thank you all. I think just a sort of makes me think about sort of the place for those early pregnancy assessment centers and in really as an opportunity to bridge that gap for folks who are really needing that early pregnancy care. Jessica, I think you're sharing the slides, you can go to the QR code at the end, I think, or perhaps this next question is really about what diagnostic criteria, or do the diagnostic criteria differ in abortion restrictive settings, or for folks who are in different settings, are you challenged to utilize sort of evidence based or sort of established processes for establishing a diagnosis of an early pregnancy loss? Can I just, I was going to make one more comment about the last question real quick first too, about something you just mentioned, which is that, I think, unfortunately, you know, with growing sort of maternity care deserts and other things that are changing in our country, changing legislation, I think, unfortunately, more and more patients are going to be presenting to emergency departments as sort of their first line for early pregnancy care, either because they haven't established care or because care is further away for them. We've just finished recently a national qualitative study with emergency medicine providers, talking about their views and a national survey of emergency medicine providers as well. And they are very much thinking about this and concerned about this too, and wanting to provide the best care that they can. But this leads into this next question about how things differ in abortion restrictive states. So many emergency medicine providers practice either in institutions where they feel like they're not really able to provide care beyond just expectant management and discharging people as long as they are not at immediate risk to their health. And in terms of this question specifically about whether the diagnostic criteria differ in abortion restrictive settings, I would love for my colleagues to address that. But I just wanted to say that while, you know, I think the diagnosis of EPL is the same, unfortunately, what we're able to act on and what kind of care people are able to receive, unfortunately, does differ. But I would love to let my colleagues jump in. This is an everyday struggle in South Carolina and other states that are like my state. And so just like any other, you know, medical situation, did the diagnostic criteria differ? No, no. Pregnant people are pregnant, you know, and they can be treated the same way. But we do recognize the reality of the legal situation. And so while we are trying to encourage using multiple different modalities or a more expansive interpretation of the diagnostic criteria, we do recognize that there may be legal implications. At this time, to my knowledge, there are no states that legislate a definition of miscarriage or early pregnancy loss that would say in these cases or on this cutoff, this is considered a miscarriage and this is considered a viable pregnancy, this is considered miscarriage and this is considered abortion. So to my knowledge, there are no states like that. I could be corrected. So in the absence of that, I would advocate for using your best medical judgment and doing what's right for the patient. But also, you should be in line with your institution's policies so that you know you'd be supported in case something does run up the chain. And if you are not an institution and independent, you may want to consult your lawyer. And I am not a lawyer and I am not giving any legal advice. Well, thank you, Dr. Tarleton, and I think that distinction of sort of providing care in restrictive states and like what the legal restrictions are, just again, this is not legal advice. We're not providing legal advice, but are grateful for the expertise of the folks here. We have a question here about PUL, and I will say we are excited. We just scheduled, we've just held a date for a PUL webinar that will happen in September, so more to come. And in the meantime, we will direct you to the Society's Clinical Guidance Document on Pregnancy of Unknown Location. So very excited for that. We have a few more minutes if anyone else has any questions. If not, we can go ahead and wrap up, but I'll wait around for any additional questions. While we're waiting, since I was like very wishy-washy, well, I'm wishy-washy on the questions that there is not strict evidence for, but for example, regarding the last question about abortion in restrictive states, just in my experience, I work at a couple of different institutions. One of them has suggested very strict criteria for EPL interpretation because of legal risk. And so when I'm there, I know that I need to adhere by certain criteria so that I am supported by the administration and supported by their legal team should something happen. In another setting, that is, there's not anything on paper that, or anything formal that suggests that we need to adhere to a certain strict cutoff or certain numbers or criteria. And so there, when I feel like it's appropriate, I can incorporate more information or use slightly relaxed criteria for diagnosing EPL before intervening. Well, thank you so much to our fantastic speakers for today's webinar on early pregnancy or medication management of early pregnancy loss. And thank you all for attending our webinar and answering and asking questions. If you have any additional questions, you can follow up with us at CME at society. And thank you all very much for attending. Have a great rest of your day.

early pregnancy loss

medication management

mifepristone

misoprostol

obstetrics and gynecology

systemic barriers

telemedicine

patient-centered care