Laurence Shields, MD, compares postpartum hemorrhage control devices

A late-breaking study presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting found that intrauterine balloon tamponade and vacuum-induced hemorrhage-control devices perform similarly in managing postpartum hemorrhage (PPH) when used as part of a standardized response algorithm. The study also found that earlier device placement—before blood loss exceeds 1,500 mL—reduces failure rates and the need for transfusion.

Laurence Shields, MD, is System Physician Vice President at the Women and Infants Clinical Institute with CommonSpirit Health in Santa Maria, California.

The study, led by Laurence E. Shields, MD, and colleagues, analyzed outcomes from 66 hospitals within CommonSpirit Health between August 2022 and February 2024. During this period, there were 123,292 deliveries, with 5,931 cases (4.8%) of postpartum hemorrhage. A hemorrhage-control device was used in 666 of these cases: 300 (45%) with an intrauterine balloon tamponade (Bakri balloon) and 366 (55%) with a vacuum-induced device (JADA system).

Device performance was similar overall

The primary outcomes included blood loss after device placement, red blood cell transfusion rates, and device failure. The median blood loss after device placement was comparable between groups: 194 mL (interquartile range [IQR] 67–440 mL) for balloon tamponade and 240 mL (IQR 113–528 mL) for the vacuum-induced device (P=0.40). Transfusion rates were not significantly different between the devices, with 59.7% of patients in the balloon group and 50.0% in the vacuum group receiving packed red blood cells (P=0.08). Similarly, transfusion of 3 or more units occurred in 27.0% vs 24.9% of cases, respectively (P=0.53).

Device failure, defined as needing a second device, interventional radiology, or hysterectomy, was also similar: 7.7% for balloon tamponade and 8.5% for vacuum-induced (P=0.70).

Earlier placement improves outcomes

The data showed that timing of device placement significantly impacted outcomes. When either device was used after a quantitative blood loss (QBL) between 1,000 and 1,499 mL—aligned with stage 2 of the system's hemorrhage response protocol—transfusion rates and failure rates were significantly lower than when devices were placed at QBL ≥1,500 mL. For example, device failure occurred in only 3.4% of cases with earlier placement compared to 12.9% with later placement (P<.001).

“Your failure rate goes up [and] your rate of transfusion goes up” as blood loss increases before device use, said Dr. Shields. “If you can reduce the probability of transfusion by putting this in early, it's going to offset the cost of the device, regardless of which one you use”.

Training in both devices recommended

Despite the similar efficacy, Shields emphasized the importance of being familiar with both devices. In one-third of device failure cases, success was achieved after switching to the alternative device. “Just because you fail with one device doesn't mean you need to move to hysterectomy. Try the other device and see if that'll work for you,” he said. “They should have JADA devices on board, and the providers need to know how to use both of them”.

While both devices had similar outcomes, the balloon tamponade is considerably less expensive. Shields noted that the cost difference initially prompted the evaluation. “Should we be paying 6 times more for one device versus the other?” he said. “If one of the devices worked better and it cost a little bit more, that might be worth it. If they don't, then I think it's a little bit harder to justify the cost”.

Conclusion

The findings support the use of either balloon tamponade or vacuum-induced devices within a standardized hemorrhage protocol. However, earlier placement, before blood loss exceeds 1,500 mL, improves outcomes. Given the similar performance, cost, and the possibility of secondary success after initial failure, clinicians should be trained in the use of both devices and consider early intervention to optimize care.

Reference:

Shields LE, Klein C, Torti J, Foster M, Cook C. Effectiveness of the Intrauterine Balloon Tamponade Compared With an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device for Postpartum Hemorrhage. Obstet Gynecol. 2025;145(1):65-71. doi:10.1097/AOG.0000000000005770

Disclosure:

Shields reports no relevant disclosures.