Bakri Shortened In-Utero Time: An RCT (July 2026)

Summary

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Episode Overview

Title: Bakri Shortened In-Utero Time: An RCT (July 2026)
Host: Dr. Chapa’s Clinical Pearls
Guest: Morgan, rising M2 with interest in obstetrics
Date: July 15, 2026

This episode provides a lively, evidence-based discussion on the optimal duration for Bakri balloon use in the management of postpartum hemorrhage (PPH). Dr. Chapa and guest Morgan review a groundbreaking July 2026 Green Journal RCT that compares 6 versus 18 hours of intrauterine Bakri balloon tamponade, exploring what the findings mean for clinical practice.

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Key Discussion Points & Insights

1. Background and Rationale for Bakri Balloon

• Understanding PPH Danger:

  • “There’s about 500mls that goes to the uterus at term. So if you combine that with uterine atony and exposed open vasculature, a patient can get into danger very, very quickly.” [00:11]

• Origin of the Bakri Balloon:

  • Dr. Yannis Bakri’s innovation in 1999: “Hey, if it's bleeding, let’s stick a balloon in there and see if it works.” [00:43]
  • FDA approval followed in 2002.

• Manufacturer’s Instructions:

  • Maximum duration is 24 hours, but there’s no stated minimum: “Once bleeding is controlled and the patient is stable, it can be removed.” [01:09]
  • The optimal minimum duration for effectiveness was previously unknown.

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2. Prior Research & Need for New Data

• Previous Evidence Lacking:
  • Earlier studies (e.g., Ironson et al. in the Gray Journal) were retrospective and small-scale. They indicated effectiveness for placements of 2 or 12 hours, but were not conclusive.
• Significance of the New Study:
  • First “pragmatic randomized, non-inferiority” trial of its kind analyzing 6 vs 18 hours. [01:42]

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3. The July 2026 RCT Explained

Study Design and Meaning

• Pragmatic RCT:

  • “Pragmatic means it happened in a real world clinical setting...Non inferiority is just saying is treatment A just as good as treatment B...Pragmatic, real world, randomized. That’s level one evidence." [05:11]

• Randomization:

  • 64 women with PPH were randomized 1:1 to 6 hours (33) or 18 hours (31, after 2 protocol violations) of Bakri balloon tamponade. [06:29]

• Time Choices Explained:

  • “They explained that they chose 18 hour duration of intrauterine balloon tamponade use as the standard... Six hours was chosen...as a significantly shorter duration of use that’s clinically relevant.” (Morgan, reading study methods) [07:12]
  • “It’s not complicated...Literally, they said 6 is shorter, 18 seems a little longer...So don’t read too much into it.” [07:29]

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Management and Protocols

• Observation & Antibiotics:

  • Patients were observed for vitals, bleeding, and urinary output; given antibiotic prophylaxis during balloon use; Foley catheter and vaginal packing stayed until balloon removal. [08:03]

• Pragmatic Approach:

  • If bleeding was “determined to be excessive...participants could be removed...and managed as deemed appropriate.” [08:44]
  • “We’re not gonna let our trial get in the way with you doing the right thing.” [08:44]

• Antibiotic Use:

  • No formal society guidelines, but recommended due to foreign body and tissue pressure. [08:44]

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4. Study Population and Blood Loss Severity

• Substantial PPH:
  • “Here’s what the mean QBL was when these patients were enrolled. What was that?”
    – “2,133 milliliters, y’all.” (Morgan) [09:35]
  • “That’s two liters. These patients needed help.” [09:38]

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5. Primary and Secondary Outcomes

• Primary Outcome:

  • Successful blood control compared between groups.

• Quantified Results:

  • Median blood loss after balloon placement:
    – 6-hour group: 110ml
    – 18-hour group: 135ml
  • “The non inferiority margin that was set...has to be within 250mls. This difference is like 20mls. So there was no difference...” [10:36]

• Secondary Outcomes:

  • No difference in additional uterotonics or transfusion needs. [10:36]

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6. Practical Pearls & Clinical Takeaway

• Shortest Effective Duration:
  • “They conclude that it may be reasonable to remove the balloon after six hours.” (Morgan) [11:42]
• Clinical Application:
  • “If your new intern says, ‘Hey, she stopped bleeding, I want to remove this at six’ — don’t say, you’ve got to leave it in for 24. 24 is the max. So there really isn’t a minimum.” [11:46]
• Context from Other Studies:
  • Other trials indicate bleeding is controlled often within two hours, so prolonged duration is usually not necessary if hemostasis is achieved. [11:46]

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Notable Quotes & Memorable Moments

• “So much blood. So much blood.” [00:07 & recurring]
  Dr. Chapa and Morgan continually punctuate the discussion with this tongue-in-cheek, Family Guy–inspired phrase, both lightening the educational tone and underscoring the urgency of PPH.
• “We’re just trying to fulfill our life calling and our mission... Welcome to Clinical Pearls.” [02:24]
• “It’s a foreign body, puts pressure on the walls of the uterus, and the uterus is denuded. So, yes, I think it’s absolutely vital to give antibiotic prophylaxis.” [08:44]
• “Just because you can leave it in for 24 doesn’t mean that you always should when there’s some effect as early as two hours. And according to this publication, non inferiority was seen at six hours.” [12:33]
• “Never forget is this: So much blood. So much blood sucks.” [12:48]

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Timestamps for Key Segments

| Timestamp | Segment/Topic | |------------|-------------------------------------------------| | 00:11 | Physiology and risk of PPH | | 00:43 | History and FDA approval of Bakri balloon | | 01:09 | Manufacturer’s guidelines (24 hr max, no min) | | 01:42 | Announcement of new RCT (Green Journal, July 2026) | | 05:11 | Definitions: pragmatic study & non-inferiority | | 06:29 | Study groups and randomization | | 07:12 | Rationale for choosing 6 vs 18 hours | | 08:03 | Management protocols and rationale | | 09:35 | High mean blood loss in enrolled patients | | 10:36 | Study results: blood loss in both arms | | 11:42 | Author’s conclusion — 6 hr removal is reasonable| | 12:33 | Clinical implications and take-home lesson |

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Conclusion

This episode delivers a clinically relevant, evidence-backed update for managing PPH with Bakri balloon tamponade. The July 2026 RCT shows that a 6-hour intrauterine time is just as effective as 18 hours for blood control, enabling earlier removal and reducing patient discomfort and risk. Dr. Chapa’s engaging style and Morgan’s adept participation make both the research and its practical implications accessible to trainees and providers alike.

Memorable Takeaway:
“So much blood. So much blood sucks. But don’t keep the Bakri balloon in any longer than you need—six hours may be enough if bleeding is controlled.” [12:48]

Transcript

[A]

So much blood.

[B]

Postpartum hemorrhage really sucks.

[A]

Yeah, postpartum hemorrhage is terrible. I mean remember this, there's about 500mls that goes to the uterus at term 500mls. So if you combine that with uterine atne and then there's exposed and open vasculature, a patient can get into danger the very, very quickly. So Morgan, if we have a patient with postpartum hemorrhage and medications haven't worked, we gotta do something, we gotta act fast. That's why back in 1999, look at that, an OBGYN physician, his name was guess, what was his name?

[B]

Bakri.

[A]

Dr. Bakkeri actually came up with this idea. Hey, if it's bleeding, let's stick a balloon in there and see if it works. He was out of Georgia. Phenomenal. So again, creativity and ingenuity and demand. May Dr. Yannis Bakkery come up with this idea. Then spring forward to 2002 and it was actually FDA approved. Now Morgan, right now the manufacturer guidelines say that for the Bakri cooked balloon it should stay in inside the uterus for a maximum of 24 hours. But here's a catch. They don't give any minimum. All it says according to the instructions is quote, it's left to the clinician so that once bleeding is controlled and the patient is stable, it can be removed. But we really don't know the optimal time that the balloon can stay in there and still be effective. Now there has been past publications like one from the Gray Journal, that's the American Journal of OB GYN by Ironson et al that had 247 women that found that hey, if we leave this in place for 2 or 12 hours then it works. But it was a small number, it was retrospective. And two hours wasn't really an endpoint. It was just something that some people did. So it kind of had some study limitations. But now Morgan, there's a brand new RCT from the Green Journal. This has authors from Denver and Vermont that's coming out this month in July of 2026 that gives us the first of its kind pragmatic randomized trial and it's for non inferiority. We're going to talk about that in this episode to see if six hours of bacchary is just as good as a little bit longer as 18 hours and what they found. So Morgan, what do you think? You think six hours is going to be enough or is it too short?

[B]

I hope it'll be enough, yeah.

[A]

Because the truth is, having a big balloon inside the uterus is not comfortable. It can lead to infection. There's voiding issues. So in this episode, we're going to tackle the July 2026 new publication from the Green Journal that asked this question. Is 6 hours just enough as 18 hours? Because PPH sucks so much blood. So much blood. So we got to get ahead of it. I think I've said it up enough. Me and Morgan will be right back. We're just trying to fulfill our life calling and our mission. This is Dr. Chapa's OBGYN no Spin podcast. Sorry I have to do that again. I just like that. So much blood. If you all don't recognize that, I'm glad you don't, because it's appropriately stupid. That's from Family Guy. And that's the talking little dog. I forgot his name. I don't remember. But anyway, Stewie's a little baby. So much blood, and the dog is talking to him. That has nothing to do with obstetrics. Just threw that out there. Our guest for this episode is an M2. They just transitioned over because we're doing this in July, the same month that this new study is coming out. And that is Morgan. Morgan is phenomenal. She's spent a lot of time with us in labor and delivery and is interested in the best discipline out there, which is obstetrics. Morgan, say hello.

[B]

Hi.

[A]

So, of course, we're talking about the Bakri. Now, there's a lot of different ways and toys that we have to try to control bleeding. Once uterotonics fail, we got Bakri. There's something called the EB balloon. Some people call it ebb. Depends on where you are in the country. Whatever the ebb. EBB balloon. It's another tamponade balloon. And of course, we've got the complete opposite way. Instead of dilating the uterus out, collapse it down with the Jada. That's a vacuum device. And then, of course, we've also covered a buddy of mine who's an MFM fellow who published as a fellow, just putting a Foley inside the uterus, connecting that to wall suction, and then letting the uterus contract down as a DIY Jada. Basically, it's do it yourself vacuum. And it does work. So there's all these different ways to do it. However, this new July 2026 publication from the Green Journal is focused on the Bakri. Now, Morgan, let's get into this a little bit because I want this to be relatively quick. We're Trying to figure out if six hours is as good as 18 hours. And do you remember what's the maximum length of time that it can stay in?

[B]

I'm not sure.

[A]

Well, the length of time according to the manufacturer is 24 hours. Right. So it can stay in for as long as 24. But it risks infection, it's uncomfortable. The patient is connected to this tether. So we're trying to see if shorter times work. This was actually the first non inferiority RCT trial that was considered pragmatic. All right, Morgan, I'm going to throw this out. You're an M2. Welcome to Clinical practice. What does a pragmatic study actually mean?

[B]

I actually have no idea. Dr. Chapa, what does a pragmatic study mean?

[A]

Well, and that's why we got to know what these words mean, because I'm not making this up. Authors actually say this is a pragmatic randomized non inferiority trial. So let's break this down real quick. Pragmatic means it happened in a real world clinical setting, not so much in a stroke structured, very black and white clinical trial environment. This happened on a real world in labor and delivery. Non inferiority is just saying is treatment A just as good as treatment B without really having any predetermined notion of what that is. In other words, are they too comparable to each other with one being the standard and then the other being the competitor to see if they are non inferior. So that's pragmatic, real world, randomized. Everybody gets what that is. That's. That's level one evidence comparing six hours versus 18 hours. All right, guys, so here's where we're going to go. In total, 64 women with PPH said, hey, I'm going to partake in this study. Let's go. So this is how this worked. Hey, you're at the bedside. Oh, my goodness. You qualify for PPH as a diagnosis. Let's randomize you in a one to one fashion between six hours or having it in for 18 hours. So in total, there was 33 in the six hour group and 31 patients in the 18 hour group. So more Morgan, is that weird? It's one to one. How are we missing two in the 18 hour group?

[B]

Two were excluded for protocol violations.

[A]

Yeah, so that's the catch. So there was one to one. So that's why there's a little disconnect there. The total number is 64, but it ended up being 33 in the six hour. 31 in the 18 hour because two protocol violations got in the way, so you got to kick them out. But nonetheless, it's still pretty equal. Right. So basically, 30 in one camp, 30 in the other to see if this pragmatic, randomized, non inferiority trial worked. All right, Morgan, here's where we're gonna go next. It seems a little random. Six hours, not four hours and 18 hours, as opposed to like 22 or 24. It is totally random. Why did they pick those hours, Morgan?

[B]

Well, they explained that they chose 18 hour duration of intrauterine balloon tamponade use as the standard for comparison of non inferiority. 6 hours was chosen for comparison because this is a significantly shorter duration of use that is clinically relevant for the comparison of our primary and secondary outcomes.

[A]

Yeah, so she read that directly from the study, y'. All. So it's not complicated. Literally, they said 6 is shorter, 18 seems a little longer. So we're just going to choose that to see if those two make sense. There's no science there. They very well could have chosen four and the traditional 24. So that's just what they chose. So don't read too much into it. Six hours. Fine, 18 hours. Great. So basically, it was their choice. Now, they also get into the specifics of how these patients were treated, which gets into things like antibiotics and what this actually looks like. Morgan, tell us about this.

[B]

Yeah. After intrauterine balloon tamponade placement, participants were observed on labor and delivery or the intensive care unit as appropriate. During that time, vital signs, urine output, bleeding output from the balloon tamponade and vaginal bleeding via sanitary pad weights were recorded. Antibiotic prophylaxis was administered routinely during intrauterine balloon tamponade use. Per institutional protocol, Foley catheter and vaginal packing remained in place until the intrauterine balloon tamponade was removed. As a safety measure, if any participant's intrauterine balloon tamponade, catheter output or bleeding at six hours was determined to be excessive by the treating physician, the participants could be removed from the study and managed as deemed appropriate by the physician.

[A]

All right, y', all, did you get that? That's the definition of a pragmatic study. In other words, we're not gonna let our trial get in the way with you doing the right thing. If you think she's hosing and you gotta get either the balloon stay in or take it out and do something else. Now, Morgan, there's something in there that's super important that you covered. These patients got antibiotics. There's no formal society guideline that says that. However, it definitely can be Considered, I think we had an episode in the past on the show, and that's something that we do. It's a foreign body. It puts pressure on the walls of the uterus, and the uterus is denuded. So, yes, I think it's absolutely vital to give antibiotic prophylaxis. All right, fine. So these patients had block randomization at time of their PPH diagnosis. And Morgan, it's right here in the publication. These patients had real pph. Here's what the mean QBL was when these patients were enrolled. What was that?

[B]

2,133 milliliters, y'. All.

[A]

That's two liters. That's on PPH, right? So this isn't like 500. Sometimes you read publications, Morgan, on postpartum hemorrhage, and they use the old cutoff of 500. Even though it's 1,000. These patients were bleeding. So the mean QBL, nothing. Like, why would you wait until they're 2,000? Because you're doing stuff and this can get out of hand very quickly. So the mean blood loss on these patients. Think about that. Two liters. I mean, these patients needed help. Fine. So they had 2000 blood loss. Boom. Block randomization. You go into the six hours, you go into the 18 hours. The primary outcome, super easy, was the amount of blood control. Blood loss control, the same in each group. So let's take a look at the median QBL once you put in the balloon at the end of the trial period, six hours or 18. And super easy, in the six hour group, the amount of blood that was lost was 110mls. Not bad. That's pretty small. And how manymls of blood loss was it in the 18 hour group, Morgan?

[B]

135ml.

[A]

All right, did y' all get that, guys? So the non inferiority margin that was set, in other words, what they calculated as it's not a significant difference, has to be within 250 MLS. Well, this difference is like 20 MLS. So there was no difference in keeping that balloon in for 18 hours or six hours because it didn't meet what they considered would be too much of a difference. That's called a non inferiority mark. There was also no change in secondary outcomes, by the way. There was no need for additional uterotonics, one compared to the other, or transfusion. So it worked. So the short answer, guys, in this very directed podcast episode, because we're actually at work. Morgan, where are we right now?

[B]

We are in the student lounge at the hospital.

[A]

Yep. As always, you know we're multitasking. We got patients going on, but everything is calm, everything is good. We broke away a little bit to do this because as always, we want to let you know it's hot and press. And this just came out in the Green Journal. Plus we talked about postpartum hemorrhage with our new interns. So I thought, let's get this out. So, in brief, Morgan, what are the conclusions from these authors on this pragmatic, non inferiority RCT comparing 6 hours to 18 hours of BACRI?

[B]

Yeah. They conclude that it may be reasonable to remove the balloon after six hours.

[A]

Yeah. So, guys, the whole point is if your new intern says, hey, she stopped bleeding, I want to remove this in six, don't say, you've got to leave it in for 24. 24 is the max. So there really isn't a minimum. There has been other studies that have looked at this. We talked about the two hour one. There was also a French trial that looked at seven hours less than that or more than that. And short of it is it worked. And here's why this matters. You probably get good bleeding control, guys, within the first two hours. I mean, if you're still bleeding after that, something else is going on, so you don't necessarily have to have it in for the entire duration. The take home message guys here as we get ready to wrap this up is based on this brand new rct, which, guys, this is a big deal because most of the other evidence is observational and or retrospective. You probably don't need to leave it in that long. Just because you can leave it in for 24 doesn't mean that you always should when there's some effect as early as two hours. And according to this publication, non inferiority was seen at six hours. Morgan, thank you for doing this.

[B]

Thank you for having me.

[A]

And always don't forget the key lesson, guys. Never forget is this. So much blood. So much blood sucks. All right, podcast family, as always, we're thankful for you. We'll see you on the next episode of the no Spin podcast. This is Dr. Chapma's obgyn no spin podcast.