 As Susanna described, we're going to talk a little bit about a modality that some people in the world know quite well, and many do not, and we spent perhaps the past eight years focused on understanding the opportunity to make differences in postpartum hemorrhage, and not just with, there's no single vertical drop-in device or approach that will treat all women. But for this particular talk, I'd like to spend our time, I think, focused on this specific modality. Susanna, how do I make a slide go forward? So you can't, you will see an arrow that goes next at the very bottom of your slide. I can do that for you. Oh, I see. Okay. Great. Okay. So this is a woman in South Sudan, and just as a reminder to all of us that postpartum hemorrhage is the number one killer of pregnant women on earth, and about 2.8 million women either lose their lives or become disabled from pregnancy-related causes on earth, and the number one cause is postpartum hemorrhage. This woman is from South Sudan, and that's a country that has arguably the worst maternal health indices on the planet, I guess, rivaled by some areas of the border of Somalia and Kenya, Afghanistan, and Sierra Leone. But in South Sudan, as high as one in six women will lose their lives from pregnancy-related causes in her lifetime. And there is no other gap on our planet that is as wide as the gap of safety and survival in pregnancy than that between the haves and those that are lucky enough to live in well-resourced settings and those that are not. So our work, looking at how to be helpful in the domain of postpartum hemorrhage, began eight years ago, and eight years ago we were asked by the World Bank as well as the Ministry of Health in South Sudan if we could go ahead and develop a package to support the emergency conditions that most likely were confronting mothers, children, and newborns at the community level in South Sudan. And South Sudan certainly is an extraordinarily challenging environment, has supply lines that are essentially non-existent, and in some areas of the country truly couldn't be more austere or rudimentary. And so we thought hard, you know, we spent quite a bit of time working with stakeholders as well as with providers in the country to find what were the, we ended up with nine different areas of focus, and then one of those of course ended up being okay, postpartum hemorrhage at the community level in South Sudan is a primary killer, is a major killer. How could we authentically become, how could we authentically try to be helpful? And at that time, eight years ago, there were no euteronics in South Sudan at all, and we weren't in a position at that time for a variety of political reasons to be able to bring euteronics to bear. Therefore, I went out and I personally bought 20 Bakri balloons and realized that I would personally go bankrupt if I continued along this particular path. And so we realized it was time to really look around the planet and who's done what, where, and how, and then design something new that we could try. So we developed the euteron balloon that really a take off from some other varieties but self-contained not using IV tubing and not needing things that actually didn't exist at the community level in South Sudan. This is essentially what it is, it's a 60cc syringe, it's a 26 or 24 fully catheter with a lower lock in the end so you actually can use the fully catheter itself as an introducer as well as essentially the sort of the pipe down to a condom that is ultimately just tied to the end. We developed a package that was not just this device but also a training package which included really a horizontal approach and all of active management of the third stage of labor plus, you know, plus euteron balloon but also plus all other advanced modalities so that this was really a horizontal look at postpartum hemorrhage. We went ahead and deployed this in South Sudan and soon thereafter started hearing stories, stories coming from different parts of the country but stories aren't science and stories are not going to save women's lives at large so we did in one area of the country that was safe as safety was becoming more and more of an issue. We had trained 874 frontline health workers, basically traditional birth attendants, illiterate frontline health workers and we conducted a small case study basically using what's called snowballing approach in eastern Equatoria and came up with, you know, came across 14 women who were profoundly ill, hemorrhaging uncontrollably and yet the providers had learned about use of euteron balloon tamponade and had successfully been able to arrest hemorrhage and save these women's lives. So with that information we weren't going to change the world but we did go ahead and ask the country of Kenya, the Ministry of Health, would you like to build on this and would you like to work with us to see what we might be able to do to afford, you know, the opportunity to save lives elsewhere in the world? So sure to form the Ministry of Health in Kenya said well gosh we're just here are 12 facilities and they were all facilities run entirely by an unbelievably focused, each facility an unbelievably focused and, you know, entrepreneurial midwife and this included in western Kenya in some poor areas as well as the slums of Nairobi. Over that first year, some seven years ago or so, we ultimately had 24 cases of women that began hemorrhaging and failed euteronics and continued to hemorrhage and all 24 of them survived, you know, with a balloon being placed and arresting their hemorrhage. That became really a tipping point, we were able to gain some grant resources and then we were able to expand the work from then on. So rolling forward to today, we have now deployed this package. So it's wall chart checklist, a three hour training program, principally for midwives, but certainly also for other whoever is delivering babies in whatever region that we've been asked to come work. So this is now deployed in nine countries. This is now national policy in Ghana and in Kenya and in India and there are a number of other countries knocking on the wall, knocking on the door, in fact 22 countries, the Inter-American Development Bank has asked that this package be brought into eight countries in central and South America. So there's lots and lots of work to be done, incidentally, anybody that's listening or anybody that knows anybody that's interested, we have no shortage of opportunity to work together in countries around the world as this is beginning to expand. We have now quite a bit of research that we've conducted and in fact so much so that it's really no longer necessary to try to prove that a uterine balloon can play a key role and can arrest hemorrhage, but now the research that really needs to be undertaken is how can we create implementation strategies so that women all around the world do have access to the ability to end their maternal hemorrhage before the maternal hemorrhage actually ends their lives. So the summary of our findings to gate in brief that we have really strong data that shows the following, that a uterine balloon can immediately arrest hemorrhage. All cadres of folks at the lowest level of birth attendance can place the uterine balloon. Overall, we have a 97% survival from uncontrolled postpartum hemorrhage when all else is failed and that's not trivial because the entry criteria as for WHO and for all of our research is that a woman that has failed uteritonics, failed other nonoperative modalities and oftentimes they've failed a couple of doses of uteritonics so they're fairly downstream and have such a high survival rate is encouraging. We have very good evidence from two countries in a study that we did that it averts emergency hysterectomy. Now, when a mother presented, so one of the comments that's come up fairly frequently is why don't you just publish a recipe, it's a fully catheter, it's a syringe and people can do this. So interestingly enough, we actually looked at that quite carefully and probably no surprise to any of us that without having something packaged, without having something organized and with a clinical pathway that's supportive, survival rate drops precipitously and it makes sense and what we learned mostly is that people actually, if they have a recipe, they actually don't put this together and then suddenly when a woman's in trouble people go oh my goodness and scamper around and try to jury-rig something together, doesn't work nearly as well and there's significant delay. We also have followed women and there are no complications, actually we've had one case of endometritis that did just fine. So I'll go over just a little bit more detail here but we have a shock paper that'll be coming out in the IJGO, International Journal of Obstetrics and Gynecology and here's the bottom line and that we have a four country cohort of women, just over 300 women that have had uterine balloons placed when all else has failed, they're actively hemorrhaging and they have failed multiple doses of uterotonics. In our cohort we have just over 40% of them that were actually in shock and it means that their blood pressure had begun to drop and that they also have an altered mental status. Interestingly enough, so long as your blood pressure isn't yet below 90 and they don't have an altered mental status, they essentially have a 99 to 100% survival when a uterine balloon is placed. Makes sense if you can arrest hemorrhage before people start spiraling into a state where DIC is looming and where they've begun to cascade into abnormal pathophysiological responses, chances are good women will survive. Class III shock, which is a blood pressure between 90 and 70 systolic and an altered mental status but not unconscious yet, Class III shock, we are still lucky enough in a large cohort of 97% survival so a balloon is placed, hemorrhage is able to be arrested and they're able to be resuscitated, most often in the regions where we have done this work that type of fluid resuscitation is actually oral because they're remarkably lower level settings. Now survival drops precipitously when a mother is unconscious and her blood pressure is less than 70 systolic, the survival rate is 86%. One would certainly expect a much higher percentage, these are again women that have uncontrolled hemorrhage but 86% now is unfortunate, we're losing significant number of mothers, actually every mother is significant, nonetheless it is an improvement over an expected mortality. So I think really what we hear here is if someone is having uncontrolled hemorrhage don't wait until they're unconscious and have a blood pressure less than 70 before you actually try to intervene and arrest their hemorrhage with a uterine balloon. Another, I mean I touched on this but we actually formally looked and published a couple of papers that while improvised use or improvising a uterine balloon is able to save lives that its success rate is much lower than if a kid is at the ready and a kid is designed to in fact able to rapidly expand the urine balloon which is the condom at the end. We use 60cc syringes and we discovered that when people improvise most areas or midwives or traditional birth attendants or lower level facilities don't have 60cc syringes, they might have a 10 or a 5 and if we just noticed recently we looked carefully in India and the mean amount of water placed into one of these is 550cc so if someone has a 5 or 10cc syringe you can imagine the amount of times you need to actually try to pump, draw water and pump in order to be able to fill a balloon. Now postpartum hemorrhage, while it takes most of the lives that it takes are on the African continent, I think all of us know that it can happen most anywhere in the world at really any level of care and the rates here are quite interesting and different but certainly in low resource settings somewhere around 4 to 5% of women will have postpartum hemorrhage per the definition which is actually a rather outdated definition and then somewhere around 10% of those will fail standard interventions and would be then candidates for a urine balloon. Now emergency hysterectomy we looked into countries of Senegal as well as Kenya and essentially went through a formal type of mixed methods research process across 30 doctors that had placed between them just over 80 uterine balloons and we analyzed their care for and after introduction of the uterine balloon and these doctors all had the capabilities of performing hysterectomies or facilities where they could perform hysterectomies and then essentially saw that the uterine balloon really abolished the practice of hysterectomy. I must say we were just in Tanzania last week and we have implemented the uterine balloon in Dar salon in the capital amongst the national teaching hospital as well as the surrounding three district hospitals and the chairman of OBGYN lamented that suddenly he doesn't know how he's going to train his residents how to perform emergency hysterectomies for hemorrhage because in the last year since the urine balloon was implemented it suddenly don't have emergency hysterectomies to perform when previously it was a common operation on that very interesting and interesting quandary so to speak if one would want to call it that. Safety we tracked 183 women consecutively who had uterine balloons placed there was one case of endometritis otherwise there were no uterine balloon associated complications and this is really suddenly become in a very important study that was just conducted I had no expectations this would be the case but we've just learned that the food and drug administration here in the United States there's a path to obtaining approval so this that really will help open the doors for rural regions in the United States Canada and other areas of the world that that might use the food and drug administration as a guideline as to whether something can be adopted so at the end of the day happy-looking mom with a beautiful little baby this is of course what we all seek and I think I think our elective pause here so that we can have some conversation but I think it's important to walk away from this and recognize that anybody can put in the uterine balloon and the balloon the balloon device that we use that there are many of them out there there's no need to spend 400 US dollars for a uterine balloon but what is important is that once the decision is made to place a balloon that that that don't feel constrained to have to only put in a certain amount rapidly fill it until the bleeding stops certainly condoms are high volume low pressure systems they've been tested at MIT as well as path in Seattle and they won't rupture a uterus and and and it's interesting to see that we have we have as much as 1200 cc's having been placed in a balloon filling a uterus after a twin delivery so it can really vary anywhere from generally 250 300 cc's all the way up to 1200 cc's and as I just described out of the cohort of 57 cases since just in the last since the end of January amongst the proof of concept implementation in India the mean amount of fluid placed in a balloon was 550 cc's survival rates are very high and especially high if a balloon is placed early it can avert emergency hysterectomy obviously if you wait longer a woman has a tougher time of surviving and in fact I say this not with not meant to be any humor but the reality is we have several cases around the world where where a woman is essentially more bun dead and somebody places a uterine balloon hoping that the uterine balloon will will will bring her back and and the uterine balloon cannot raise people from the dead at that we do know we know it's safe and and as I stated we know that al-Qadres can place the uterine balloon so with that I'd like to go ahead and pause and Zana do you want to moderate some conversation if we can yes so thank you very much for the presentation if anybody has a question please go ahead I know see we also have some pools and we will invite the audience to participate in that so to those questions there you go there so from the participants have you ever had a case of unresponsive postpartum hemorrhage we see the number is increasing for the death we also have a question for from Eva I'm just going to finish the poll here but it seems like more than a half of the people who answer to you actually have had a case of unresponsive postpartum hemorrhage so I'm going to end this okay so even question is how long does the balloon stay in the uterus even that's a great question and nobody knows the answer exactly and I think you know we generally say you know don't take it out in the middle of the night you know light of day is a better time to certainly take the uterine balloon out but generally speaking you know 10 12 hours but you know I think the way I would describe it also or think about it is that not all postpartum hemorrhage in fact I would say all postpartum hemorrhage each case is different just as if you if someone said to you how long should I keep a bandage on this area on my arm that I you know that I cut open the question should be well how big is that cut the same thing will be true with the endometrium do we just have a small area that's that that's the cause of the hemorrhage or has been there is there a large area of tissue that's at risk and vulnerable and so generally you know if someone has a massive hemorrhage and they're sick the balloon is going to be kept in longer it's common sense and so it's really about judgment so suppose at the 10 hour mark you think wow she's been really stable for a while and you may take out 50 to 100 cc's and see where you are just just pause for half an hour see if she does fine see if she's there's any recurrence of bleeding if not then take out another 50 cc's and maybe every 30 minutes take out 50 cc's. Thank you for your answer. We have another question from Fatima. She's asking if this study is only useful for poor countries. Yeah so the research that we've been undertaking has been in many different countries and it's been in all the way from national teaching hospitals and for instance in India the Ministry of Health insisted that it starts off with very high level tertiary care medical schools that are must say are as equipped as anywhere in the world and it's gone all the way down to the most rural level and most difficult setting that you can imagine. So it's basically every setting where this has been utilized. However I must say originally this was thought to be for South Sudan and then similar poor countries but since then I've certainly learned that there are plenty of midwives family doctors and others in even in the United States that have asked my goodness we cannot afford a $400 US balloon for our community level where I particularly practice and you help us and the answer is of course yes. Thank you. We have another question from Teri. Teri says that she's trying to figure to picture how the condom is used at the end of the fully capture. Yeah so there's some there actually is a how-to video that we had made by medical aid films in London that I think we can refer people to at the end here but essentially you can imagine taking a string and tying a condom the end of a fully catheter where the string is the string is actually and where it's tied the actual fully balloon itself is beyond that beyond being it's inside of the actual area of where the of where the condom is so then you can put this up with two fingers you know insert it up through the cervix into the uterus and then the first thing you do would be to take the fully balloon port and fill that go ahead and fill that with 20 cc's 30 cc's of water now that will actually help hold the fully catheter I mean help hold the condom under the end of the fully catheter and then you can move to the other port which has a lure lock in it and now fill that with water until the condom is tightly in place and that actually functions as the uterine balloon I hope that helps but I would ask you know refer you to to the video that will send you you know the website so you can look at that video thank you I actually have shared the webpage link in the chat box so you can visit the webpage and you will see more you'll have more information there as well there are a number of videos there that have been made by midwives that you might find enjoyable and interesting to see okay so Terry says that thank you that was quite clear okay Teresa Teresa I just wanted to say that I think this is a fantastic and could see a place for this for a midwife supporting woman to birth outside the hospital setting I cannot agree more yeah make make make it safer for women everywhere they're delivering so Terry is asking another question and Lee we have Sarah is sharing yes very yes hmm yes Terry you made a very good point for those communities that they have regulated home births that would be a great option you know the link that share Sarah shared so we're going to wait until Eva is typing her question I guess we can go to the polls again yep I mean I really like what Terry wrote and this is something we've been thinking about for a while not just not just you know when when there are actual kits that are organized and in place we all function better and what we do in an emergency circumstance at you know the more sort of program that is and this is something that I'm actually going to the Gates Foundation next week actually to work and think this through and if there are people on the on here that are particularly interesting interested in the in thinking about various aspects of what it would mean to put together an emergency kit for midwives I I would love for you to let Susanna know and we can put our heads together in a different forum because I think this is I think you're right on this is something that we should think about certainly beyond facilities and and there's no woman that's not at risk so so this really is this is something that we should think about for the whole world not just for poor women or for certain subgroup yes okay so we have another question from Eva do you have any idea how it works compared to I would normally use I would not take it it's not competitive with it's not one or the other of course so it it really interesting that you know euteronics we were beginning to learn more and more about euteronics and that you know different euteronics do function a little bit differently you can very quickly gain down regulation in other words you can use a euteronics couple of times and then realize it doesn't work anymore and but a different euteronics may work and the euteron balloon probably has a mechanism of action it's not just about pushing against the the endometrial you know area that's that's really hemorrhaging and and and a board through an a bird's bit I mean it really you know stops the hemorrhaging but it probably also is able to stimulate the endo cervix and the lower lower euteron segment in a unique way that also contributes to contraction and so none of us know this and this is a more hypothesis than anything Indian OBGYNs are absolutely convinced and this is perhaps they put a lot more fluid than other countries but that actually that a euteron balloon of built the uterus and then it tilts back which kinks off the euteron artery which that's what they think is their mechanism is the mechanism of action maybe that's true I don't think any of us know however I think I think we I mean use euteronics as you normally would and the uterus when it if it does and when it does actually contract we see this often that that the uterus will you know it needs to rest and then when it sort of regains its its oomph that it contracts and pushes the you know sometimes it'll just push the it's the hour of six six hours or so push the uterine uterine balloon right out of the uterus and you know into the vagina will spill out so so I think think of them as complimentary yes so do we have any other questions from from the audience as we are waiting for more questions let's go to the next poll because we are curious to know on you can see there if you have ever if you have ever had a patient who had to go for an emergency sterectomy due to and controlled post-prime hemorrhage wow and it keeps increases and it's almost 70 percent of the audience has an emergency emergency sterectomy due to eph good and it keeps going up yeah and if we imagine in those settings where they don't even have an OR facility so that's even more terrible so let's go to our next poll while we're oh there's another question from Alicia so are there cases where this is not effective I would say that that we have women that have uterine balloons placed when they have lost a great deal of blood already and they're in shock and and then are in DIC and have a coagulopathy such that that you know they still are in this horrible downward spiral and don't survive balloon was placed too late or they had had a fetal demise that had been quite times you know ago and and these women are terribly sick that's really you know you know that's yeah they're they need more they need blood products and they need they need other interventions if there's going to be a chance to survive the uterine balloon you know isn't isn't sometimes able to answer their need certainly the uterine balloon is you know generally it's it's a one certainly by WHO standards and others it's reserved for atonic uterus only however there are some amazingly creative midwives that we've that have taught us all sorts of things that they've done such as you know using it intentionally for multiple lacerations within the vagina and just one midwife actually just ultimately could not stop hemorrhaging from many different locations vaginally and placed a uterine vagina blew it up and kept it there for two days and then the woman did well we have other we certainly have post-abortion hemorrhage that is significant and life threatening where we have a number of cases of uterine balloon use and other uses as well but generally speaking and certainly for the political arena oh we just we describe it for atonic postpartum thank you again so I think Alicia is asking and typing another question just to remind you oh thank you it sounds yeah no as if they are not often used where the you know we have 117 facilities that are laboratory so to speak and we have 547 uterine balloons placed and we have not seen that yeah okay and terry also is asking or making a comment would be interesting to see data on women who have had this great question hey if I had a uterine balloon am I going to have a normal pregnancy next time or has something changed or happened we don't have that data we don't have reason to believe the uterine balloon is you know it's certainly a traumatic but you're right we don't know really so that's a very good question for our future research um so tima is typing a question I believe uh so just to remind everyone well that we're going to be wrapping up in the next three minutes so we'll give some time for the next presenter so ask all your questions uh tima is but he's I cannot understand it well your question for tima you're asking about is this may be increased I'm sorry can you write again your question for tima and Cecilia and I oh thank you Cecilia it says that I think we should spell it familiar that is absolutely myometric with blood and one contract and something so we all know that yeah when they're when the uterus has clots in the you know in the in the cervix or in the uterus itself that it prevents the uterus from doing it from doing its thing you know which is contracting however we also know that you know uterus become exhausted and dysfunctional or a functional and uh you know what the what the uterine balloon probably does is it stops the hemorrhage letting the uterus recover its um its normal state and when it recovers you know then it's time to uh you know begin to withdraw the uterine balloon and allow it to um you know allow it to contract on its own so and you know something that actually has come up in discussion a lot my goodness if the if the uterus is filled with this with this balloon is not going to act in this similar vein to a you know clot and it's going to prohibit the uh the uterus from contracting well we haven't seen that we have plenty of cases of where the uterus uh contracts and pushes the balloon out but um you know this is anecdote I don't have I think it's a very fair question and something that we need to understand better the good news is that you know when the when the balloon keeps the uterus distended and the bleeding is stopped when the balloon is finally taken out the uterus nicely contracts so I think we have to learn more about how this all actually interacts but for now it's um it is a resting hemorrhage and it is saving lives but uh indeed it does interact in some various ways with contraction of the uterus and the last coming from Fatima this is so important because you cannot um construct a uterus I guess that's what you mean so we're just getting at the very end of our session I don't know if you have any other slides there uh yes so many yes that you have a lot to have happy life and uh and have children that go on to uh you know be healthy and uh and uh but really all of it depends on the very beginning and what happens at this moment in time yeah okay so everyone is saying thank you for the session thank you for this so yeah yeah yeah so we just and yeah thank you so much Dr. Thomas for being with us a best session um just so just to finish this presentation oh together we can make the world a better place what a nice way to finish the presentation so um right now we're gonna stop we're gonna turn off our recording