Fetal Pillow®: For Full-Dilation Cesarean Section

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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 forty five minutes for the presentations. Our presenters will participate in a question and answer session upon conclusion of the presentations.

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I am very pleased to introduce our presenters.

Doctor Rajeev Varma, consultant gynecologist from Nuffield Health, Brentwood Hospital, and the inventor of the fetal pillow, doctor Sarah Lassie from Brigham and Women’s Hospital and Harvard Medical School, and finally, doctor Joseph Chiaffe, director of hospitalist division and hospitalist fellowship program at NYU Langone Hospital, Long Island.

Tonight, we will begin with doctor Varma. Good evening, doctor Varma.

Thank you, Jim, for the introduction. My name is, Rajeev Varma. I’m a practicing OBGYN 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 a patient who is memorable for all wrong reasons.

This is a 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 suture.

She bled, and we and we had to transfuse her about, ten units of blood. She ended up in intense intensive care, but fortunately made a complete recovery. Sadly, the baby didn’t do so well, and twelve 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 sec at 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 two hundred and four hundred and forty patients.

And, they asked the question from the physicians who were carrying out these emergency cesarean sections to grade the difficulty in delivery from one to ten, and they found that, sixty three percent of full dilution in sections had some difficulty, at delivery.

The other two studies are randomized trials of fetal pillow. And as you can see that around forty percent 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.

These patients don’t have too many complications, possibly some uterine 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.

So full dilation cesarean section seems to vary from country to country, even hospital to hospital, due to practices, being different and the local populations.

There are a few studies which we have here, which have shown the incidence of full dilation cesarean sections in various countries. The first study is from UK. This study was, done in two thousand and one, so almost twenty years ago. The most recent study is from Lopez from US, which interestingly had fifteen percent full dilation ciliary 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 dilations there in section.

So what happens, in these patients? The, the head is deeply engaged. Often, there is extensive molding and caput. The lower segment is very thin and overstretched.

Because of prolonged labor, sometimes the LICA volume is very reduced.

And often, there is extensive manipulation required to deliver the fetal head.

This is the study from the Norwegian birth registry of seventeen thousand 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 intraoperative complications, which increases the total complication rates. And one can safely assume that all this is due to a difficult delivery of the fetal head.

There is a lot of data around this now, and we know that these patients have higher rate of uterine extensions.

They have increased intraoperative blood loss and higher rate of blood transfusions.

These operations are complex and often would take a 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 two thousand and four, this was ten thousand births. Out of those, two hundred and nine 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 uterine incision, 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 gonna 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 will often damage lower segment and can occasionally risk cause injury to the fetal skull. And after trying for some time, 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 OR 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 it in my opinion, it gives a false impression that it’s an easy procedure to perform.

Anyone who’s done this will realize that there is 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 impaction and an awkward, direction of pushing.

This is not an oftenly used technique, and most people don’t know how to do this.

I think it is almost like a rotational forceps, which has gone out of fashion. There are not many people doing it, which means there are not many people out there to teach anyone.

But I do believe that most both these techniques, using hand from below or reverse breech have high fetal injury rates, and they are rescue methods, which are delivering a baby, which physician has found impossible to deliver using the normal method. And and I do not think they have any place in modern day obstetrics.

So the two thousand and five 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 till the baby was delivered. And this is how the concept of fetal pillow came about.

Fetal pillow is a simple device, which is inflating in only one direction. As you can see, it’s a very small device. It’s, very soft and easy to insert. It comes in a sterile package with a sixty milliliter 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 Perinatology in two thousand and ten.

And I contact contacted professor Seale, who was the 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 we’re very interested, and we would like like to do a pilot study. And if if we like using it, we would definitely be interested to do a randomized trial.

So we send them fifty devices, and they use those fifty devices as a pilot, which got which was published, in two thousand and fourteen. They compared this pilot cases to the previous study, and and showed that using fetal pillow reduced complications.

They then proceeded to do a randomized trial.

This trial was published in the International Journal, and this was a study of two hundred and forty patients in two hospitals.

So there were two hundred and forty patients in the study, hundred and forty patients in the fetal pillow arm, and the other one twenty patients, used the surgeon’s preferred method of delivery if there was difficulty.

The primary endpoint of this study was uterine extensions, and the secondary endpoints were postpartum hemorrhage, blood transfusions, length of hospital stay, time taken for cesarean section, uterine incision to delivery interval.

And neonatal complications like admission to neonatal intensive care, trauma, or death are also important secondary endpoints.

So this is a slide showing the maternal outcomes. And you can see that the uterine extensions in the fetal pillow arm were five percent compared to thirty two point five percent in the controls.

Operating time was significantly lower in the fetal pillow arm, almost twenty one minutes. This is the total operating time. And uterine incision to delivery interval was also lower.

These patients lost less blood, four point two percent losing more than thousand mils compared to twenty two percent.

And, obviously, these patients needed less blood transfusions, three point three compared to eighteen point three, and spent, on an average, one day less in the hospital.

Fetal outcomes, the numbers were too small to reach statistical significance, but these outcomes, do do show a trend towards better, fetal outcomes.

This to me is is probably the most important slide, which shows the ease of delivery. And and you can see quite clearly that in the fetal pillow arm, the delivery was made significantly easier compared to the non fetal pillow arm where forty percent, 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, in Brisbane.

They had had two 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 was 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, hundred and sixty patients. Ninety one of these were fetal pillow group and sixty nine hand push.

And in this study, they 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 and show you how to use it.

As you can see, this this is the device. It is very small. It’s, very soft. It’s made of silicone, 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 posteriorly as possible, almost like placing a posterior vacuum cup. And once the device is placed posteriorly, 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 the 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 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 fetal head quicker, easier, and less traumatic.

It reduces 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, doctor Varma. Our next presenter will be doctor 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 twenty percent of labors and are a common indication for cesarean delivery.

Arrested descent 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 injuries such as skull fracture.

And as you just heard from doctor Varma, the fetal pillow is a balloon cephalic elevation device designed to elevate a deeply impacted fetal head atraumatically out of the pelvis during cesarean delivery.

When the fetal pillow has been evaluated before, it was associated with a reduced risk of major hysterotomy extension.

Prior studies have found a fifteen percent risk of extension with a hand from below compared with only four percent of the fetal pillow and a randomized controlled trial showed a reduction from thirty two point five percent to five percent in hysterotomy extension.

Our study was a double blinded randomized controlled trial at a single academic tertiary care center, and our objective was to evaluate whether the fetal pillow decreased the time of delivery from hystereotomy to delivery as well as the uterine hystereotomy extension rate.

We decided to include women aged eighteen to fifty who were with term pregnancies, which we defined as thirty seven to forty one and six seventh weeks with singleton pregnancies in a cephalic presentation.

We included only nulliparous women, and we excluded anyone with a contraindication 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 cephalic elevation device inflated group or the not inflated group. At the time of delivery, the fetal pillow was inserted vaginally by the obstetrician after Foley 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 a hundred and eighty cc’s of saline or not as the surgical team was scrubbing.

Following delivery, the circulating nurse accessed the device and either deflated the fetal pillow or carried out a mock deflation, and the fetal pillow was then removed by the delivering provider at the end of the procedure.

Our primary outcome was time in seconds from hysterotomy to delivery of the fetal head, and we used 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.

Watch. We assessed a variety of secondary outcomes including the 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, DIC, ICU admission, and length of stay, a composite neonatal morbidity score including birth weight, one and 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 HAP was considered clinically meaningful, and for a Type I error of zero point zero five and eighty percent power, assuming equal sized groups and a two sided p value, we found that we needed thirty 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, four thirty nine women, malibarous women, were consented during the first stage of labor who presented with term vertex singletons.

Many of these women, three seventy nine, 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 or patient or provider preference and declined being in the study.

Sixty of those women who underwent a cesarean delivery in the second stage were then included, and thirty were randomized to the fetal pillow inflated group and thirty 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, BMI 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 historotomy 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 zero point zero five.

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 noninflated group.

Otherwise, there were no differences in our other secondary outcomes including blood loss, change in hematocrit, 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 controlled trial on our labor and delivery, therefore minimizing confounding.

We also were able to establish 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 generalizability given the fact that we included only women at a tertiary academic care center who were nulliparous.

So in summary, we think use of the fetal pillow decreases time to delivery as well as decreases the uterine hystereotomy extension rate. Thank you.

Thank you, doctor Lassie. Our final presenter will be doctor Chiaffe. Doctor Chiaffe?

Good evening, everybody.

I’m doctor Joseph Chiaffe. I’m an associate, clinical professor of OB GYN at, NYU Langone Hospital Long Island.

I’m also the, division director for the hospitalist division, for OBGYN, 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.

I was introduced to the fetal pillow approximately four years ago, the end of two thousand seventeen, where doctor Nish doctor, Varmin and 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.

They brought us a fetal pillow.

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, the discussion and, the questions and the answers, I said, we were pretty much on board with giving it a trial. It made a lot of sense.

Doctor Varma gave us his background on how he came to develop this this, fetal pillow, which was unfortunate, but some real good came out of, what he had done.

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 will be a new addition to the hospital because it did involve purchasing, you know, more equipment, and there had to be some justification for its use.

And the thing that sold the fetal pillow was doctor Varma’s 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.

They unanimously agreed that we could purchase this and stock it and start to use it, and we went from there.

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, we’ve used approximately and I looked at the purchase orders, but I didn’t look at, individual usage and patient’s charts and things like that for a lot of different reasons, HIPAA being the number one reason. Plus, it’s hard to pull that 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.

To date, we’ve used approximately over three years approximately three hundred fetal pillows.

We do about fifty five hundred deliveries a year, so we’re using basically two a week.

And it comes in very handy. I mean, at a volume of two a week, we’re definitely sure what we’re doing with this fetal polo and what the significance is in the clinical setting.

The simplicity of the design is what really attracted me.

To be honest with you, I was a little upset that I didn’t think about this, before doctor Varma, but it was a great design. It’s very simple. You don’t need a computer. You don’t need 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 insufflate it, and you’re good to go. I mean, an in service what we basically did was, when we got the fetal pillow, we did an in service with everybody involved that would be involved, other attending physicians that were available at the time, the residents 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 ORs at our our facility.

You know, we’ve all been there where we’ve had a patient there we’re inducing or claims in and labor has a long labor, a long protracted day. You’re into the evening or the night, gets to fully dilated, and now she’s pushing. So that continues on, continues on, and now she’s pushing for two, three, four 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, that 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 this today prior to fetal pillow, you’d go back to the OR. 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 doctor Varma maybe talked to you about his his history with that and how this came to be that he developed the fetal pillow. That’s not optimal. It’s not an opt it’s what we had, but it really wasn’t optimal. And now this fetal pillow takes that and and definitely just puts it on 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. And you know there’s no room in there and you know the width of your hand, and the proportions are are gonna 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 and 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 and let’s step back a little bit. You take the patient to the OR, you lay her on the table after her anesthesia is taken care of, you frog leg the patient, and you basically you insert it like you would insert a pessary for a GYN patient for incontinence or a a diaphragm fit for a a patient who needs contraceptive, 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 insufflate. You’ll you’ll you won’t get what you want in terms of the elevation and and the application.

Once the patient’s back in the dorsal spine position, you strap her in like you normally would for a c section, you insufflate with a hundred and eighty cc’s of norm of, sterile saline, and you really you don’t wanna go less than that. I mean, you don’t wanna do sixty, you don’t wanna do one twenty, you wanna 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 incisions so that you don’t have to get down there and dig it out or cause any trauma that you’re gonna regret.

You insufflate it. You 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 with your case. It’s simple. I 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 wanna, 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 year 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.

And it really requires there’s no trauma. There requires no other instruments. And once it’s in, you’re good to go.

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 problem whatsoever in terms of the the insertion or they’re not sure, there’s always one of the hospitals around. They’re gonna 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 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, this 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, a pelvic exam and an insertion and an insufflation. And the insufflation 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 scrub, 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. We’re up to three hundred 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 three hundred 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 attraction.

It’s not just the physician that thinks about it. It’s sort of on the checklist.

What about the fetal pillow? I’m gonna pull it out. We 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 our OR, 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.

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 causing some trauma to the baby. You know? You’ve gotta get in there.

You gotta flex the head. You gotta pull it up. The if this instrument gets you halfway there so that you’re doing almost a routine, you know, scheduled c section, life is good. Life is easy.

Any questions, I’ll be glad to answer anything you have in terms of application usage, you know, whatever you wanna talk about. I’d be glad to take any questions, and, we can go from there.

Thank you, doctor Varma, doctor Lassie, and doctor Chiafi.

Just as a reminder, you can ask a 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.

The first question that we have, will be directed to doctor Lassie and doctor Chiafi.

With your experience in your institutions, with the fetal pillow, what was the process that you had to work through to have the device trialed and approved? Who was involved? And how was this accomplished? I’ll start off with doctor Chiaffe.

Basically, to get any sort of new equipment into the hospital, you would have to present it at some sort of committee that controls your durable goods and your purchases of of new equipment, sutures, things like that.

We have what’s called the value analysis committee that I had to present, the fetal pillow to in order to get it into the hospital for us to use. And we were trialed on this, which was fine, and we’re given some samples, which was fine. And once we were convinced that this was something that we wanted to use and that we wanted on formulary, I basically had to present this to the committee to, to get their approval. And the easiest way to do that is you don’t go to your nurse manager on labor and delivery or, you know, anybody you know, your OR person that that buys supplies and things like that.

You’d have to formally go to the committee and you have to present your argument. And the easiest way to do that is is to be convinced that this is what you want and to buy into it. I mean, when I presented this this whole fetal pillow and why we wanted it and what the benefit was and and what the usage would be, etcetera, etcetera, you have to present a little bit of what you want it for and what the benefit is to the hospital in terms of, you know, reducing maternal morbidity, decrease in, in malpractice exposure, etcetera, and cost analysis that it’s gonna be worth it for them to invest and give you this product so that you can do a better job on their labor and delivery unit.

And that’s basically where we went with this. And to be honest with you, go in there with a pitch. Don’t just go in and say, hey. I want this thing.

It’s really great. I saw it at a at a at a Zoom conference, and I’d really like to try this. That’s not gonna work. You have to go in there and be convinced that this is what you want.

And to be honest with you, I plagiarized doctor Varma’s, case that motivated him to produce this thing. And when I got done presenting that case his experience as to why he developed this, there was no question that this was gonna be approved. There was dead silence, and they just asked us, you know, when we wanted it. I mean, they were that convinced that this was a good option for our hospital in terms of their liability, patient safety, baby safety, and our being able to do our job with less complications in terms of maternal morbidity.

It’s almost like being on Shark Tank. You’re going in there and asking for something. You gotta convince them that they wanna buy into this, that you need this, and this is a good product.

Very good. Well, thank you, doctor Chiafi. Doctor Lassie, what was your experience at the Brigham?

Our experience was a little bit similar and also a little bit different, given the fact that a trial had been ongoing, for, you know, about a year and a half. Many providers had had exposure and as well as the residents had had exposure to the fetal pillow. And so we continued to use them after the trial was done mostly with schools and things like that. And then we recently submitted a similar process to doc to that that doctor Chiaffe mentioned, so that they continue to be stocked on our labor and delivery. I think one of the things that we’ve done to try and encourage people to continue to use them is education with the residents, as well as with the private practice attendings at our institution so that people feel comfortable still asking for them and making them readily available if people, would like to use them during the second stage arrest cesarean section.

K. Very good. Thank you, doctor Lassie. And and doctor Chiaffe, if you can just follow-up doctor Lassie’s, point. Once approved in your in at at NYU, Langone, what were the key steps to training and rolling out to your staff? What were the key, aspects of what you did to be able to roll out and have your staff use it?

Basically, you know who’s gonna use it. I mean, the practitioners are gonna use it. Nursing needs to be on board, and the resident or whatever staff you have that’s gonna be assisting you in the OR needs to to know how to use it. And we basically gave in services to the private attendings, the community physicians.

We did in services for the nurses, and we did in services for the residents. And we did it more than once only because it was a new item. And there are always some questions after you go to a service and, you know, you say, well, jeez. I should’ve asked this or I should’ve asked that.

So we did it a couple of times, and it became a part of our checklist for for cesarean section. I mean, when we were going back for a case that patient patient had been pushing for three or four hours and fully dilated and you think you’re gonna have an issue with extraction, it was a no brainer. It it was more than one person who was saying this, this, this in the fetal pillow. And so we had a checklist situation where it was on it, and it wasn’t missed because if I didn’t think of it right away, my resident would think of it.

If the resident think of it, the nurse would think of it. So everybody had a checklist that they were looking at or going through or an algorithm, and it was avail readily available to us.

And we probably used, you know, we use probably a hundred a year at least, which is probably two a week, which is fair representation to say that this is something that we bought into and something that, you know, we like.

Okay. Very good, doctor Tiaffe. I have another question from the audience. They’re coming in right now.

And I’ll start with doctor Varma on this, and this can cross over to the all all all the doctors.

Who places the fetal pillow? Is it placed by the MD or the RN?

And, doctor Varma, if you wanna give your experience in your in your experience, and then also I’ll move to doctor Lassie and doctor Chiafi.

Thank you, Jim. Most of the devices are placed by the doctors.

And this is in in England, the device has been used now for over ten years.

Some of the hospitals we talk to, they say, well, they we I think the practice in UK is a bit different because we have midwives delivering all the normal deliveries. So the midwives some of the midwives who are very experienced will occasionally place the device, but most of the devices are placed by the physicians or the residents.

And I don’t know how it’s probably very similar in US.

And doctor Lassie, what what’s your experience with who places the actual device?

So it’s the same as it was during the trial. So the MD in the room, whether it be the attending physician or the resident, does the, vaginal prep with Betadine and then places the fetal pillow.

And then it can be, deflated by the RN, and then it’s removed at the end of the case by the attending or by the doctor in the room.

Okay. Very good. Doctor Chiaffi?

Yeah. We basically do the same procedure as doctor Lassie. I mean, we have residency training program, so it’s either the attending physician the attending physician or it’s the resident.

And then for the extraction, it can be the nurse or the resident or the attending, whoever’s available, but we basically follow the same format.

Okay. Very good. I have a question, that came in, from the audience here about are there and and maybe I’ll start with doctor Varma. Are there any contraindications for use or restrictions for gestational age? And then a follow-up, do you use vaginal prep before placing the fetal pillow? If you wanted to start doctor Varma and then doctor Lassie, doctor Jaffe.

I think in terms of the gestational age, all the clinical data we have, which we which was presented to the FDA was in term pregnancies, chephalid presentation. Right. So I think, the device is indicated to be used after thirty seven weeks. Right. We we don’t have any experience using it in premature births, and, so it’s only indicated in term pregnancies.

Okay.

Very good. And doctor Lassie?

Our study, was limited to just term gestation, so after thirty seven weeks as well. And that’s typically what we use it for since the study was done.

Okay. And then I have another question. I’ll start with doctor Varma, maybe just doctor Varma. Can the device be inserted after the hysterotomy if a difficult extraction is unexpectedly encountered?

I think the simple answer is, probably no. All the clinical data we have or all the user data we have is that the device elevates the head before you make the incision.

I I personally believe that once you’ve made the incision and all the fluid has come out, it probably gets harder to elevate the head. But we just don’t have any data. So I’m not convinced the device will work. But, I don’t know whether anyone else has had that experience.

Doctor Lassie or doctor Chiaffe?

No. We haven’t had that experience. I mean, I I think it’d be a very difficult placement because you’ll basically have to break down your your surgical setup if, you know, to position the patient differently, to insert it, etcetera. I don’t think it it it’s an option, to be honest with you.

Okay. So I have, I have a question just more directed to doctor Chiafi. As director of the hospitalist division and hospitalist fellowship program at your institution, can you provide some insight to the role of the hospitalist in the decision making process and the adoption of the fetal pillow in your institution?

Sure. Base you know, as a hospitalist, we staff the hospital twenty four seven with a hospitalist or two hospitals depending on what, you know, the need is. We’re basically there all day, no place to go except to stay on labor and delivery and monitor what’s going on. So, basically, we’re the people who have the information on anything like the fill your pillow or anything new that comes out because we’re the people they approach, you know, to to get this into the hospital.

We do in services for everybody. We are available, you know, for placement, you know, or preoperative consultation or suggestions, you know, as we’re going down this road and clinicians start to think about, you know, I’m gonna, you know, do this section. I’m gonna possibly get into this and possibly get into that. And we educate.

We train everybody. We train the residents. We train the fellow, and we train the attendings until they get comfortable doing it. And if they’re uncomfortable doing it or they haven’t had much experience or they don’t wanna chance it on this particular patient, we will insert, the device and and, you know, that will be it.

I mean, and the hospitals, for example, it’s a it’s a person that’s there twenty four seven who just takes care of complications or issues that arrive that are are a little out of the ordinary or may need a second opinion or may need a suggestion, etcetera, etcetera. The clinician record will do the case, but this makes it so much easier for them, and they feel so much more relieved in a situation like this where they’re not gonna get into a a situation where they’re gonna get an extension or have an extensive surgery.

Very good. I have a question actually, from Hong Kong, from our, our attendees from Hong Kong.

Question directed to doctor Varma. Some doctors in Hong Kong just use suction to pull out the baby. Is there any study to compare fetal pillow and suction method?

I don’t understand what they mean by suction methods. Are they talking about using a vacuum device?

I would probably think so. But that if you wanna just explain then how, as far as the the the indications for the device just to reconfirm those.

There is but there is no study which compares it with suction. That’s the first thing.

And I I really just don’t understand what they mean by suction.

Right.

Works, very predictably. I I had no idea and no experience about suction.

Okay. And we we can follow-up with that doctor individually. I’ll I’ll start this question, the next question with doctor Lassie. There are some different initiatives in the United States to reduce unnecessary c sections and lower the c section rates, and, they’re varied depending upon the different organizations in different parts of the country. What is your perspective on these initiatives and the impact on the future of difficult c sections potentially involving the fetal pillow?

I think these initiatives are wonderful, and they’re trying to decrease the c section rate and increase the, spontaneous vaginal delivery rate across the United States. I think, however, we’ve seen that as people are allowed to labor longer and have a longer second stage, these second stage arrests, cesarean deliveries become more and more complicated.

Historically, I think talking to mentors and, other attendings is that this is a somewhat of a new problem in obstetrics, that this isn’t something that they’ve seen over the course of their career, but that these difficult, to deliver fetal head cesarean deliveries have really increased recently. And I think that many times, we now have, opportunity and to insert a device that improves maternal morbidity and fetal morbidity. And so that’s why I think it’s a perfect venue for a fetal pillow and why one of the reasons we did our study at our institution. Okay.

Very good. Thank you, doctor Lassie. We just have time for one more question, unfortunately.

Doctor Varma, this question will be directed to you. As you discussed in your presentation, you discussed aspects of maternal morbidity is presented more frequently than fetal injury. If you could comment on that regarding awareness of fetal injury in conjunction with this situation on, difficult c sections?

Yeah. I mean, most of the data on on fetal and maternal injuries, in full dilations there in section is actually quite old data. So So when you look at the papers, they are at least two decades old.

But there is data from from UK, which comes from the UK, what we call the the NHS resolution, which is a body which indemnifies all the NHS, all the obstetrics.

And and they started collecting data to look at the, the the brain damaged babies in in UK, which will eventually go to litigation.

And they found that nine percent of these babies, the brain damage was caused by difficult delivery at c section. So we’re talking about, you know, out of eight hundred and fifty babies a year, which we see which who have brain damage.

So we have definite data which shows that this is a problem which does cause significant fetal morbidity, particularly the cost. Cost of these babies is very, very expensive to the health care system. And I’m I’m sure US has similar problems, except that you don’t have a authority like the the NHS Litigation Authority, which has the numbers, because it’s probably fragmented, how the indemnification is done in US.

But I think these numbers are are are significant.

Right.

Okay. Well, thank you, doctor Varma. And, unfortunately, we’re we’re out of time, right now. So, I do also want to, reconfirm that, any question that has not been answered during the session here will be answered by Cooper Surgical, so you’ll receive an email with an answer to your question.

This will conclude our event for this evening. I wanna thank again, doctor Varma, doctor Lassie, and doctor Chiafi. Thank you very much for all your support and your presentations. It was a very good experience working with you. And for everyone, please take a few minutes to complete a brief survey about tonight’s program by clicking the post program survey button or utilizing the QR code provided. Thank you, everyone, and have a very good evening.

Thank you. Bye.