By Alexandra Morell, MD
Synopsis: This multicenter, prospective, observational study comparing intrauterine balloon tamponade vs. vacuum-induced devices for postpartum hemorrhage demonstrated no difference in blood loss after device placement (median quantitative blood loss, 194 mL balloon vs. 240 mL vacuum; P = 0.40), need for blood transfusion (59.7% balloon vs. 50.0% vacuum; P = 0.08), need for more than three units of packed red blood cells (27.0% balloon vs. 24.9% vacuum; P = 0.53), or device failure (7.7% balloon vs. 8.5% vacuum; P = 0.70).
Source: Shields LE, Klein C, Torti J, et al. 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.
Postpartum hemorrhage is the leading cause of maternal morbidity and mortality worldwide.1 The most recent definition for postpartum hemorrhage is blood loss greater than 1,000 mL or blood loss with symptoms of hypovolemia within 24 hours of delivery regardless of delivery type (vaginal or cesarean). Postpartum hemorrhage is divided into primary or secondary hemorrhage based on time to development of symptoms.
Primary hemorrhage occurs within the first 24 hours after delivery. Common causes include uterine atony, vaginal or cervical lacerations, and retained placenta. Secondary hemorrhage occurs after the first 24 hours and up to 12 weeks post-delivery. Typical causes include subinvolution of the placental site and infection.
Management of postpartum hemorrhage differs depending on the underlying etiology. Uterine atony is the most common cause of postpartum hemorrhage, accounting for approximately 80% of cases.2 Management of uterine atony can employ a combination of uterotonic medications, hemorrhage-control devices, or surgical procedures if less-invasive options are not successful. Until recently, the only hemorrhage-control devices available were uterine tamponade balloons, such as the Bakri balloon. In the last few years, intrauterine vacuum-induced hemorrhage devices, such as the Jada device, have become available as alternatives.
This multicenter, prospective, observational study conducted as part of a quality improvement initiative aimed to compare outcomes between balloon tamponade vs. vacuum-induced hemorrhage-control devices in the management of postpartum hemorrhage. All 65 included centers had standardized postpartum hemorrhage algorithms, which included the option for a hemorrhage-control device for stage 2 (ongoing bleeding with quantitative blood loss between 1,000 mL and 1,500 mL after use of oxytocin and two additional uterotonic medications) and stage 3 (more than 1,500 mL blood loss after use of oxytocin and two additional uterotonic medications, abnormal labs suggestive of disseminated intravascular coagulation, or vital sign abnormalities) postpartum hemorrhage.
The centers were required to perform audits of cases in which a hemorrhage-control device was used. The device used was based on provider choice. Data were collected from these audits between August 2022 and February 2024, focusing on demographic variables and clinical information relevant to hemorrhage. The study had four primary outcomes, including quantitative blood loss (QBL) after device placement, rate of blood transfusion, use of more than three units of packed red blood cells at the time of transfusion, and device failure. The study defined device failure as needing to use a different hemorrhage-control device, needing to consult interventional radiology for assistance, or hysterectomy because of ongoing hemorrhage. Data were analyzed based on the first hemorrhage-control device the clinician used and included t tests for continuous variables, log-transformed data for discrete variables, z ratios for proportions, and Fisher exact tests.
Of the 5,931 postpartum hemorrhage occurrences during the study period, 666 cases used a hemorrhage-control device. Forty-five percent (n = 300) used intrauterine balloon tamponade and 55% (n = 366) used vacuum devices. There was no difference in maternal age, race and ethnicity, insurance, admission hemorrhage risk assessment, and compliance with the standard hemorrhage algorithm between the two groups.
In the balloon tamponade group, 63.7% (n = 191) had a vaginal delivery and 36.3% (n = 103) had a cesarean delivery. In the vacuum control group, 70.5% (n = 257) had a vaginal delivery and 29.5% (n = 108) had a cesarean delivery. Median QBL at the time of device placement was higher in the balloon tamponade group (1,741 mL vs. 1,500 mL; P < 0.01). Regarding the primary outcomes, there was no difference in QBL after device placement (194 mL balloon vs. 240 mL vacuum; P = 0.40), need for blood transfusion (59.7% balloon vs. 50.0% vacuum; P = 0.08), need for more than three units of packed red blood cells (27.0% balloon vs. 24.9% vacuum; P = 0.53), or device failure (7.7% balloon vs. 8.5% vacuum; P = 0.70).
Total time of placement was significantly less for the vacuum device after both vaginal (6 hours vs. 17 hours; P < 0.01) and cesarean (7.4 hours vs. 20 hours; P < 0.01) deliveries. In addition, earlier placement of a device (balloon or vacuum) at a QBL of 1,000 mL to 1,499 mL compared to more than 1,500 mL was significantly associated with a reduced need for any red blood cell transfusion (39.1% vs. 70.3%, respectively; P < 0.001) and need for more than three units of packed red blood cells (13.4% vs. 38.1%, respectively; P < 0.001). The average length of hospital stay was the same for both devices (P = 0.35).
Commentary
The initial management of postpartum hemorrhage typically is focused on identifying the underlying cause and stabilizing the patient.2 This involves placement of at least two large-bore intravenous lines, fluid resuscitation, close monitoring of vital signs, and assessment of uterine tone. Bimanual massage and administration of uterotonics typically are the first steps in management of postpartum hemorrhage. If there is ongoing bleeding and other potential causes have been ruled out (cervical/vaginal lacerations, retained placental tissue, coagulopathy), hemorrhage-control devices can be a useful intervention.
The key takeaway from this study by Shields and colleagues is that both hemorrhage-control devices (intrauterine balloon tamponade and vacuum-induced devices) demonstrated equivalent outcomes in terms of post-placement blood loss, transfusion rates, and overall device failure. Uterine tamponade balloons historically have been an important component of postpartum hemorrhage algorithms.
In a prior systematic review and meta-analysis by Suarez et al, the overall pooled success rate of balloon tamponade devices in the management of postpartum hemorrhage was 85.9%, and slightly higher at 87.1% when used for an indication of uterine atony.3 Vacuum-induced hemorrhage-control devices were Food and Drug Administration-approved in the United States for the management of postpartum hemorrhage in August 2020.4 There has been limited research comparing these devices. This study demonstrates that these devices likely can be used interchangeably when employed within standardized care algorithms. The decision about which device to use can be left to provider discretion and based on device availability, staff familiarity, ease of placement, and cost. The shorter indwelling time of the vacuum device may be an advantage of the vacuum device over a balloon tamponade device in certain scenarios.
Of particular interest is the finding that earlier device placement (placement prior to a QBL of 1,500 mL) is significantly associated with lower rates of transfusion in general and lower rates of needing more units of blood (more than three units of packed red blood cells). In postpartum patients, symptoms (such as tachycardia and hypotension) typically do not present until considerable blood loss occurs (often more than 25% of blood volume), and vital and other clinical signs do not reliably correlate with the amount of blood loss.1,5 Therefore, it is important for care teams to be vigilant about calculating QBLs and following standardized hemorrhage protocols and be proactive about intervening early if necessary.
Alexandra Morell, MD, is Adjunct Instructor, Department of Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, NY.
References
1. Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum hemorrhage. Obstet Gynecol. 2017;130(4):e168-e186.
2. Giouleka S, Tsakiridis I, Kalogiannidis I, et al. Postpartum hemorrhage: A comprehensive review of guidelines. Obstet Gynecol Surv. 2022;77(11);665-682.
3. Suarez S, Conde-Agudelo A, Borovac-Pinheiro A, et al. Uterine balloon tamponade for the treatment of postpartum hemorrhage: A systematic review and meta-analysis. Am J Obstet Gynecol. 2020;222(4):293.e1-293.e52.
4. Clark M, MacDougall D. Vacuum-Induced Uterine Tamponade for Postpartum Hemorrhage: CADTH Horizon Scan. Canadian Agency for Drugs and Technologies in Health; 2022 Mar. https://www.ncbi.nlm.nih.gov/books/NBK596675/
5. Andrikopoulou M, D’Alton ME. Postpartum hemorrhage: Early identification challenges. Semin Perinatol. 2019;43(1):11-17.
