Chapters Transcript Fetal Pillow Playback Welcome and thank you for attending this event is brought to you by cooper Surgical, a leading provider of medical devices for women's health care. For 31 years. Cooper surgical has worked with health care providers to provide highly effective clinic and practice based contraceptive, surgical and obstetric solutions to complement our portfolio of trusted and reliable medical devices. We have also broadened our offerings, investing in the areas of reproductive genomics and in vitro fertilization. We are fully committed to helping improve the delivery of health care to women and their families, Cooper surgical manufacturers over 600 clinically relevant medical devices used by healthcare providers and offices, clinics, operating rooms, labor and delivery suites and reproductive IVF clinics worldwide. Clinicians overwhelmingly say they trust our products for their reliability, innovation and efficiency. We are pleased to provide this educational opportunity on behalf of cooper surgical. Welcome and thank you for participating in tonight's event. My name is Jim Young Product director with cooper surgical and I'll be coordinating this evening's program. Tonight's presentation is entitled fetal pillow for full dilation cesarean section. We have approximately 45 minutes for the presentations. Our presenters will participate in a question and answer session upon conclusion of the presentations. If your question is not answered this evening, you will receive a response from cooper surgical. After tonight's event. To submit a question. Please click the ask a question button located under this player window and complete the form. Also after the Q and A. Please spend a few moments completing a brief survey about tonight's program. I'm very pleased to introduce our presenters Dr rajiv varma consultant gynecologist from Nuffield Health Brentwood Hospital. And the inventor of the fetal pillow. Dr sarah lassie from Brigham and Women's Hospital and Harvard Medical School. And finally dr joseph Yoffie Director Hospitalist Division and Hospitalist Fellowship program at N. Y. U. Langone Hospital Long Island. Tonight we will begin with dr varma. Good evening Dr varma. Thank you Jim for the introduction. My name is Rajiv varma. I'm practicing O. B G Y N. In UK and I'm here to speak about the problem of full dilation, cesarean section and the options to manage it. This is a story of a patient who is memorable for all wrong reasons. This is a young patient who I looked after in her first pregnancy and she had a very uneventful pregnancy through the antenatal period. She came into the hospital in spontaneous labor and progressed quite normally during the first stage at second stage. The progress seemed to slow down. One of my colleagues who was looking after her made a decision that cesarean section was the best option for her. He took her to the operating room to do the procedure. I got a call a few minutes later saying that they needed my help. By the time I got there they managed to deliver the baby which proved difficult and they had somebody using their hand from below to deliver that baby and they said oh don't worry you can now go we've got the baby out. In fact, they called me a few minutes later saying that the patient was bleeding excessively and they needed some help. I went back and found that she had extensions into her cervix, going almost into the vagina, which proved very difficult to switch her. She lead And we and we had to transfuse that about 10 units of blood. She ended up in intensive care but fortunately made a complete recovery. Sadly the baby didn't do so well and 12 hours later died from severe injury to the skull. And this is this is the problem which made me think about how to solve this. The best way difficult delivery of cesarean cesarean section has not been studied till very recently. As you can see, this is probably the only study in the literature which has looked prospectively at difficult delivery at C section. This is a study from UK of 200 and 440 patients. And they asked the question from the physicians who were carrying out these emergency cesarean sections to grade The difficulty in delivery from 1 to 10 and they found that 63% of full Dallas Cincinnati in sections had some difficulty at delivery. The other two studies are randomized trials of fetal pillow and as you can see that around 40% of the controls in these trials had difficult delivery at C section. So there is obviously a spectrum of difficulty from mild to moderate to severe, mild difficulty is probably very common and and the physicians often don't even document it. Uh These patients don't have too many complications, possibly some U. Tron extensions which are easy to stitch. And these patients don't have any major problems. Moderate difficulty, on the other hand is likely to cause extensions which make the patient bleed excessively. Usually maternal complications which again do not lead to any long term problems severe difficulty however, fortunately is less common but probably leads to both maternal fetal complications and would often lead to litigation, particularly when there is damage to the baby. Full dilation. Cesarean section seems to vary from country to country, even hospital to hospital due to ah practices being different. And the local populations, there are a few studies which we have here which have shown the incidents of full dilation cesarean sections in various countries. The first studies from U. K. This study was Done in 2000 and months, almost 20 years ago. The most recent studies from Lopez, from us, Which interestingly had 15% full dilation Cesarean section rates. And there are certain predisposing factors. And this was looked at by Lopez study from us and we know that patients who are induced patients who have diabetes possibly because the fact that they produce larger babies, obesity is another factor if they had longer first stage or second stage. They are more likely to have a full dilation to there in section. So what happens in these patients, the the head is deeply engaged. Often there is extensive molding and kaput. The lower segment is very thin and overstretched because of prolonged labor. Sometimes the like of volume is very reduced and often they had extensive manipulation required to deliver the fatal head. This is the study from the Norwegian birth registry of 17,000 births and they looked at complications of cesarean sections and the morbidity related to it in relationship to cervical dilation. And you can see that with the progressing cervical dilation there is increased inter operative complications which increases the total complication rates and one can safely assume that all this is due to difficult delivery of the fatal head. There is a lot of data around this now and we know that these patients, they have increased intra operative blood loss and high rate of blood transfusions. These operations are complex and often would take lot longer to do fetal morbidity is is harder to to find. There are several studies which have looked at larger populations Have shown some increase in fetal morbidity. This particular study from UK which was published in 2004. This was 10,000 birds out of those 209 were full dilation Cesarean sections. So when we are doing cesarean section in advanced labor and make a uterine incision normally when you're doing a c. Section. When you make a neutron decision you'll usually see the baby's head below that incision but in this case when the head is deeply impacted, the fetal shoulder presents through the incision. And when that happens then you know that this head is going to be difficult to deliver. There is usually lack of space to insert the hand. Often physicians would make multiple attempts to insert the hand and during these multiple attempts you would often damage the lower segment and can occasionally risk cause injury to the fatal skull and after trying for some time and when you don't succeed, you look around and you try to find who can help. And this help often comes from the most inexperienced person in the O. R. Who's waiting around a nurse or a junior resident who probably has never done this before and they have to try to push the baby's head from below to try to make the delivery easier. This drawing is often used in various articles and in my opinion, it gives a false impression that it's an easy procedure to perform. Anyone who has done this will realize that there is a severe lack of space and inserting your whole hand is impossible. And you invariably are pushing using the tips of your three fingers, which makes the pushing extremely difficult due to deep impact shin and an awkward direction of pushing. This is not an often lee used technique and most people don't know how to do this. I think it is almost like rotational forceps which has gone out of fashion, there are not many people doing it, which means not many people out there too teach anyone. Um but I do believe that most both these techniques using hand from below or reverse breach have high fatal injury rates and they are rescue methods of which are delivering a baby which physician has found impossible to deliver using the normal method. And I do not think they have any place in modern day obstetrics. So the 2005 was when, when that tragedy occurred in my hospital. And the idea at that time was could we produce a simple device which could elevate the fetal head before starting the Cesarean section and keep it elevated until the baby was delivered. And this is how the concept of fetal pillow came about. Fiddle pillow is a simple device which is inflating only one direction as you can see. It's a very small device, it's very soft and easy to insert. It comes in Sterile package with a 60 millim syringe. Once we had made the device we were looking for a hospital to try and do a randomized study And we came across this study which was done in India and this, this was published in the American Journal of Paleontology in 2010. And I contacted contacted Professor Seal who was the main author of this study and asked them if they would be interested to try a device to try and overcome this problem. And he replied immediately saying, well we're very interested and we would like to do a a pilot study. And if if we like using it we would definitely be interested to do a randomized trial. So we sent them 50 devices uh and they use those 50 devices as a pilot which which was published In 2014. They compared this pilot cases to the previous study and showed that using Fetal pillow reduced complications. They then proceeded to do a randomized trial. This trial was published in the International Gallery and this was a study of 240 patients in two hospitals. So there were 240 patients in the study, 140 patients in the fetal pillow arm and the other 1. 20 patients use the surgeons preferred method of delivery if there was difficulty. The primary endpoint of the study was you tron extensions and the secondary endpoints were postpartum hemorrhage, blood transfusions, length of hospital stay time taken for cesarean section. You try an incision to delivery interval and neonatal complications like admission to neonatal intensive care, trauma or death were also important. Secondary endpoints. So this is a slide showing the maternal outcomes and you can see that the u tron extensions in the fetal pillow arm were 5% compared to 32.5% in the controls operating time was significantly lower in the fetal pillow arm, Almost 21 minutes. This is the total operating time and you try and incision to delivery interval was also lower. These patients lost less blood 4.2%, losing more than 1000 mills compared to 22%. And Obviously these patients needed less blood transfusions 3.3 compared to 18.3 and spent on an average one day less in the hospital fatal outcomes. The numbers were too small to reach statistical significance. But these outcomes do show a trend towards better fettle outcomes. This to me is is probably the most important slide which shows the ease of delivery and you can see quite clearly that in the fetal pillow arm the delivery was made significantly easier compared to the non fatal pillow arm where 40% were difficult and this this was statistically significant. Now there were studies carried out in other countries. This is a study from Australia. We were we were approached by this hospital in Brisbane. They had had to patients where there was severe damage to the babies in the preceding year and they were trying to find a way to deliver these babies safely. They approached us to see if we were selling this device. This device is being sold in Australia and it wasn't at that time and they helped us to try to get this device into Australian market and since then they've been using the device and they carried out their own study. So they had 160 patients, 91 of these were fatal pillow group and 69 hand push. And in this study they showed similar outcomes to the randomized trial from India and and similar experience has been presented in various smaller studies which have been presented as abstract to various international conferences. I'd like to show you the device and show you how to use it. Ah As you can see this. This is the device, it is very small, it's very soft, it's made of silicon and the balloon on the top only inflates in upward direction. So You have to hold the device like this. You have to fold it into two and before inserting. You've gotta you have to make sure that the tubing is facing upwards and as it is inserted in the vagina below the baby's head. The device then opens up and you have to place the device as posterior early as possible. Almost like placing an austere vacuum cup and once the device is placed austerely you have to make sure the patient's legs are flat. Then the inflation should be done just before starting the C. Section. So you can inflate as the surgeon is preparing the abdomen or even when they're making the abdominal incision. The inflation takes literally a few seconds. You need to use three syringe fulls of sterile saline and after you've inserted those sterile saline into the device you must make sure the tap is closed so that the fluid doesn't leak out and once the baby's head is delivered the tap should be opened and the fluid should be let out and at the end of the operation the device is quite simple to remove by just pulling on the tubing or just hooking the device on your finger and removing it. I think all the data we have clearly shows that fetal pillow use in full dilation. Cesarean section makes the delivery of fiddlehead quicker easier and less traumatic introduces maternal trauma and most importantly I believe that there is no safe way to deliver these babies once the difficulty has occurred and the best way to deal with this is to try and prevent the difficulty from occurring in the first place which fetal pillow achieves. Thank you. Thank you Dr varma, our next presenter will be Dr Sarah lassie. Thank you Jim and thank you so much for having me here tonight to discuss our experience with the fetal pillow. As you all know, arrest disorders can affect up to 20% of labors and are a common indication for Cesarean delivery, arrest of dissent. Cesarean deliveries are also associated with an increased risk of maternal and fetal morbidity including but not limited to uterine hysterectomy extensions, increased blood loss and neonatal injury such as skull fracture and as you just heard from Dr varma the fetal pillow is a balloon so phallic elevation device designed to elevate a deeply impacted fetal head a traumatically out of the pelvis during cesarean delivery. When the fetal pillow has been evaluated before, it was associated with a reduced risk of major hysterectomy extension. Prior studies have found a 15% risk of extension with a hand from below compared with only 4% of the Fetal pillow and a randomized control trial showed a reduction from 32.5% to 5% in history to me extension. Our study was a double blinded randomized control trial at a single academic tertiary care center and our objective was to evaluate whether the fetal pillow decreased the time of delivery from hysterectomy to delivery as well as the uterine hysterectomy extension rate. We decided to include women aged 18 to 50 who worked with term pregnancies, which we defined as 37 to 41 in 6/7 weeks with singleton pregnancies. In the symbolic presentation, we included only know Liberace women and we excluded anyone with a contra indication to a vaginal delivery prior cesarean section, presence of a congenital fetal anomaly and any non english speaking women were also excluded. Our study design was that patients who met inclusion criteria were approached on labor and delivery during the first stage of labor if cesarean delivery were then to be performed in the second stage, women were randomly allocated to either so phallic elevation device inflated group or the not inflated group at the time of delivery. The fetal pillow was inserted vaginally by the obstetrician after fully placement and vaginal preparation with Betadine, which is standard on our labor and labor and delivery unit. The provider was then blinded to whether or not the device was inflated or not. Group allocation was revealed to the anesthesia team who inflated the device with 100 and 80 CCs of saline or not. As the surgical team was scrubbing following delivery. The circulating nurse access the device and either deflated the fetal pillow or carried out a mock deflation. And the little pillow was then removed by the delivering provider at the end of the procedure. Our primary outcome was time in seconds from history to me to delivery of the fetal head. And we use time as a proxy for the marker to distinguish a difficult delivery. The time was recorded by the anesthesiologist in the operating room. With use of a stopwatch, we assess the variety of secondary outcomes including uterine hysterectomy extension and type estimated blood loss. The change between the pre delivery and post delivery hematocrit, need for blood transfusion, total operative time in minutes. A composite maternal morbidity score including fever, D. I. C. I. C. U. Admission and length of stay. A composite neonatal morbidity score including birth weight, one in five minute apgar scores, intubation, nicu admission, length of stay and fetal trauma. And we also surveyed obstetricians to assess the ease of delivery and their opinions regarding the fetal pillow at the time of use. Our analysis plan. We thought that decreasing delivery time by half was considered clinically meaningful and for a Type one error of 0.5 and 80% power, assuming equal sized group and a two sided p value. We found that we needed 30 participants in each group and we intended we intended to perform an intention to treat analysis with our data and now for the results of our trial to look at our findings as you can see here, 439 women Liberace women were consented during the first stage of labor who presented with term vertex singleton's. Many of these women, 379 were excluded due to the fact that they went on to have a vaginal delivery or a Cesarean delivery during the first stage of labor for patient or provider preference and declined being in the study, 60 of those women who underwent a cesarean delivery in the second stage were then included and 30 were randomized to the fetal pillow inflated group and 30 were randomized to the fetal pillow, not inflated group. As you can see here, our baseline characteristics across the two groups are similar with regard to age B. M. I delivery. Gestational age duration of the second stage and birth weight. As you can see here, the primary, low transverse most women had a primary, low transverse cesarean delivery in both groups and the indications for cesarean delivery are the same in both groups. Looking at our outcomes, there was a statistically significant difference in the hysterectomy to delivery time Between our two groups. We also found while it was not statistically significant, there were lower rates of extension in the inflated group compared to the not inflated group with a P value of 0.05. There was a statistically significant difference in the type of uterine extension with more of the uterine extensions being easy to suture in the inflated group compared to the non inflated group. Otherwise, there were no differences in our other secondary outcomes, including blood loss, changing him adequate blood transfusion length of stay or other markers of either maternal or neonatal morbidity. As you can see here. The provider assessment of the fetal pillow was statistically significant with providers finding the ease of delivery to be very easy in the inflated group compared to the non inflated group, providers in the inflated group were also more likely to say that they would use the device again and recommend the device to others. Overall, our study has a variety of strengths, including that it was appropriately powered for the primary outcome and it was a double blinded randomized control trial on our labor and delivery. Therefore minimizing confounding, we also were able to establish a survey based subjective data from blinded providers, which we thought was meaningful. No study, however, is without limitations and our primary outcome was a process measure time to delivery. However, it has been shown that time to delivery is associated with other markers of morbidity at the time of cesarean delivery. And although several measures of morbidity were lower in the inflated group, we were underpowered for these measures in particular and finally the generalized ability given the fact that we included only women at a tertiary academic care center who are now Liberace. So in summary, we think use of the fetal pillow decreases time to deliberate as well as decreases the uterine hysterectomy extension rate. Thank you. Thank you Dr lassie. Our final presenter will be doctor Dr. Good evening everybody. I'm dr joseph. I'm an associate clinical professor of O. B. G. Y. N. At N. Y. U. Langone Hospital Long Island. I'm also the division director for the hospital division for O. B. G. Y. N. And I'm also the Hospitalist director of the hospital fellowship program. I'm here tonight to talk to you about the fetal pillow, how we got involved and where we are with it presently. Uh I was introduced to the fetal pillow approximately four years ago at the end of 2017 where Dr dr Barman and nish, his son came to our hospital to give us an in service or a promotion discussion on using the fetal pillow. Little did I know we were the first hospital on their tour at that time. Um They brought us a little pill. They did the demonstration, they did the in service and I gotta be honest with you. It was something that was so simplistic but made so much sense that when we got done with the discussion and uh the questions and the answers, I said we were pretty much on board with giving it a trial. It made a lot of sense. Uh Dr varma gave us his background on how he came to develop this, this fetal pillow, which it was unfortunate, but some real good came out of what he had done. Um We were given some samples and we started to run with it. We started to use the fetal pillow in a clinical setting at the hospital. What I had to do initially before we even got off the ground was I had to go to the administration and I had to present this fetal pillow and why we wanted to use it and why it would be a new addition to the hospital because it did involve purchasing, you know, more equipment. And there had to be some justifications for its use. And the thing that sold the fetal pillow was dr Varmus past history and how he came to develop it and the future implications for our patients so that we would not have that same experience that he had. Uh they unanimously agreed that we could purchase this and stock it and start to use it. And we went from there. Um, I'm not talking to you about using one or two and saying, okay, this is a great item? You should really try it to date? Uh We've used approximately. And I looked at the purchase orders that I didn't look at individual usage and patients charts and things like that for a lot of different reasons, hippo being the number one reason. Plus it's hard to pull the data out. But on the purchase order, you know what you're buying, you know what you're using and you know what, you know your repurchases are uh today we've used approximately over three years, approximately 300 ft of pillows. We do about 5500 deliveries a year. So we're using basically two a week. Um And it comes in very handy. I mean at a violent to a week, we're definitely sure what we're doing with this fetal pillow and what the significance is in the clinical setting. The simplicity of the design is what really attracted me. Um To be honest with you, I was a little upset that I didn't think about this before dr varma. But it was a great design. It's very simple. You don't need a computer, you don't need uh an iphone, you don't need an app. You don't need any instruments. You pull it out of the box, it's dropped on your surgical field, you insert it, you insulate it and you're good to go. I mean an in service, what we basically did was uh when we got the fetal pillow? We did an in service with everybody involved that would be involved. Are there attending physicians that were available at the time? The resin? Certainly and nursing staff, we did it in service, we did a simulation and then we started to work with it. I personally have used it a fair amount and I gotta be honest with you. It's something that I immediately think of this. If I'm going in to do a difficult extraction, you know, and it's available readily in all the O. R. S. At our facility. You know, we've all been there where we had a patient there were inducing or comes in in labor, has a long labor, a long protracted day, you're into the evening or the night gets the fully dilated and now she's pushing so that continues on, continues on. And now she's pushing for 234 hours. And now she's wedged this fetal head into the pelvis. But you know, it's not coming. Now, you know what you have to do now you have to go to plan B. You have to go to a cesarean section. But you also know that because of what's happened all day and all evening and all night and where this head is after. You've examined her. But this is not gonna be a difficult extraction. That this head is wedged down far enough that it's gonna be an issue ideally, you know, and we do it today prior to the pillow, you go back to the O. R. You would basically look around who's around who can push from below while I go from above. And that was basically what people did. But as you know, and I'm sure dr varma maybe talking about his his history with that and how this came to be that he developed a fetal pillow. That's not optimal. It's not an option, it's what we had, but it really wasn't optimal. And now this fetal pillow takes that and definitely just puts it on the shelf. It's an easy application and it works. So basically now you're gonna do this case and you realize that you have to get somewhere into that lower pelvis between the baby's head and the anterior uterine wall in such a way that you don't cause a problem. You know, there's no room in there and you know, the width of your hand and the proportions are going to be very very difficult to adjust. And so what happens in that situation is you do the best you can. But what people tend to do is they tend to get down there, realize they're having a problem and then start to rotate their hand around and wind up with an extension. And that's the worst case scenario you got an extension deep down the pelvis, you've got bleeding and now you're looking at, you know, a protracted, you know, cesarean section. What it basically does is you insert, you let's step back a little bit, You take the patient to the O. R. You lay her on the table after her. Anesthesia is taken care of you frog leg the patient and you basically you inserted like you would insert a pastry for a G. Y. N. Patient for incontinence or a diaphragm fit for a patient who needs contraceptive uh help. But basically this is easier than that. Much much easier than both of those scenarios. You put it in, you lay it flat and and horizontal, you cinch it up underneath the coccyx and you insulate you won't get what you want in terms of the elevation and and the application once the patient back in the dorsal supplying position you strap her in like you normally would for a C. Section you inflate with 100 and 80 CC's of norm of sterile sailing. And you really you don't want to go less than that. I mean you don't want to 60 you don't want to 1 20. You want to maximize the effect because I guarantee you that you're gonna want every everything you can out of this fetal pillow to get that baby's head up into the incision so that you don't have to get down there and dig it out or cause any trauma that you're gonna regret, you insulated your head comes up, you do your normal delivery, you flex the head, you deliver it and then you deflate the balloon. You don't have to take it out immediately, you deflate the balloon, which is easy. It's a lure lock. You can either deflate it with a syringe or you can snip off the end and basically it'll just run out and just deflate and just sit in the vagina until you're done in your case. It's simple. I can't believe how simple this is and it wasn't thought about years ago. We do a lot of, we get a lot of offers for, I call them gadgets. People want to, you know, take a look at this. What do you think this is for this? This is for that. We see them, we really don't buy into them because we can do it without something else less expensive. But this here made so much sense. And it was so simple and anybody can do it. I mean, your resident can do it. You certainly can do it. Uh and it really requires there's no trauma, there requires no other instruments. And once it's in, you're good to go, um The outcomes are good. I mean, I haven't heard of one or, and people come to me all day long with, you know, successes or failures just to run it by somebody or to make it known. And if there's any any, any problem whatsoever in terms of the the insertion or they're not sure there's always one of the hospitals around, they're going to make sure it's inserted properly, it takes all of two minutes from start to finish. And like I said, you're gonna the you know, people say, well when when someone comes to show you something new and on the market and coming out and looking, you know, for some market share in terms of producing this uh this uh instrument and selling it. You know, you always say to yourself, you know, why do, why why would I want that? Why do I need that? The question you gotta ask yourself in this situation is why wouldn't I use it? Why don't I need it? Because it really requires nothing on your part other than an insertion of pelvic exam in an insertion and installation. And the installation can be done by the nurse once it's in or the resident once it's in if you have to do something else go screw up etcetera etcetera. So I think it's it's really something that I like I've seen it, We've used a number of them were up to 300 right now, more or less. So that gives us a good handle on whether this really works or not. And we wouldn't have gotten to 300 or not if it didn't work. And like I said, the staff likes it every time someone's going back with one of these situations where you know, this patient's been pushing for a long time, they anticipate some sort of difficult extraction. It's not just the physician that thinks about it, it's sort of on the checklist. What about the fetal pole, I'm gonna pull it out, We've got it available, you know and a number of people will reiterate the fetal pillow so it makes sense. And it's been well indoctrinated into our R. O. R. In terms of scenarios like this and basically it's a simple orientation for the staff. It's a one, you know in service kind of a situation where it's simple, it's done, you can do a simulation and then you'll have some samples I'm sure at the trial. Ah But I think you know it's something that you should seriously consider. It's definitely gonna help your practice and reduce any morbidity on the part of doing these these deliveries where you have a difficult extraction and you're concerned about you know getting an extension or causing some bleeding or partisan trauma to the baby. You know, you've got to get in there, you gotta flex the head, you gotta pull it up if this instrument, get you halfway there so that you're doing almost a routine, you know, scheduled C. Section life is good. Life is easy. Um Any questions. I'll be glad to answer anything you have in terms of application usage, you know, whatever you want to talk about, I'd be glad to take any questions and uh we can go from there. Thank you dr varma doctor Lassie and dr geography. Just as a reminder, you can ask the question by clicking the ask a question button below the Webcast screen. If you are in full screen, you will need to leave full screen to see it and remember. If your question is not answered this evening, you will receive a response from cooper surgical. After tonight's events, we will start the question and answer session. Created by
