Traditional uterine tamponade and vacuum-induced uterine tamponade devices in obstetrical hemorrhage management

Phillips, Jaclyn; Eppes, Catherine; Rodríguez, María I.; Sakamoto, Sara

doi:10.1016/j.ajogmf.2022.100739

Cited by 10 publications

(11 citation statements)

References 26 publications

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“…Early recognition of abnormal postpartum bleeding and timely intervention are crucial in managing the condition and preventing SMM associated with excessive blood loss. Whether PPH is defined as 1,000 mL or more of blood loss regardless of delivery route or 500–999 mL of blood loss in the setting of vaginal births and more than 1,000 mL in the setting of cesarean births, 14,21 most cases in this study exceeded those thresholds before device insertion. The blood loss volumes before the insertion of the device, together with the elapsed time from placenta delivery to device insertion, suggests either a delay in the recognition of obstetric hemorrhage or a delay in implementation of effective treatment measures.…”

Section: Discussionmentioning

confidence: 91%

“…9–12 Once bleeding is refractory to medical management, intrauterine balloon tamponade devices are commonly used to manage PPH. 13–15 In August 2020, an intrauterine vacuum-induced hemorrhage-control device (Jada System) was U.S. Food and Drug Administration (FDA)–cleared for the management of abnormal postpartum uterine bleeding or PPH. 16 The device has an elliptical silicone loop that is placed in the uterus and facilitates uterine contraction when connected to low-level vacuum and was specifically designed to control obstetric hemorrhage.…”

mentioning

confidence: 99%

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Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device

Goffman,

Rood,

Bianco

et al. 2023

Obstetrics &Amp; Gynecology

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OBJECTIVE: To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)–cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management. METHODS: Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success, defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red blood cell, intensive care unit admission, and hysterectomy) were evaluated by blood loss before insertion. To assess safety, serious adverse events (SAEs) and adverse device effects were collected. All outcomes were summarized by mode of delivery; treatment success was summarized by bleeding cause (all causes, any atony, isolated atony, nonatony). RESULTS: In total, 800 individuals (530 vaginal births, 270 cesarean births) were treated with the device; 94.3% had uterine atony (alone or in combination with other causes). Median total blood loss at device insertion was 1,050 mL in vaginal births and 1,600 mL in cesarean births. Across all bleeding causes, the treatment success rate was 92.5% for vaginal births and was 83.7% for cesarean births (95.8% [n=307] and 88.2% [n=220], respectively, in isolated atony). Median indwelling time was 3.1 hours and 4.6 hours, respectively. In vaginal births, 14 SAEs were reported among 13 individuals (2.5%). In cesarean births, 22 SAEs were reported among 21 individuals (7.8%). Three (0.4%) SAEs were deemed possibly related to the device or procedure. No uterine perforations or deaths were reported. CONCLUSION: For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04995887.

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Section: Discussionmentioning

confidence: 91%

mentioning

confidence: 99%

Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device

Goffman,

Rood,

Bianco

et al. 2023

Obstetrics &Amp; Gynecology

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“…10 Monitoring circulatory blood volume using SI is useful for fluid and blood transfusion‐centered life‐saving protocols for massive bleeding. 11 To prevent cardiac arrest due to decreased circulatory blood volume, it is crucial not only to understand the circulatory dynamics using SI but also to have a rapid high‐level facility transportation system through early administration of substitute plasma and emphasis on blood products focusing on coagulation, in collaboration with medical control. Smooth medical control activation can achieve rapid transport to high‐level facilities leading to better outcomes.…”

Section: Features Of Obstetric Crisis Bleeding Guidelines and Require...mentioning

confidence: 99%

Significance of perioperative inter‐departmental collaboration for obstetric emergency response: A mini‐review

Komasawa

2024

Acute Medicine & Surgery

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This review underscores the crucial role of interdisciplinary collaboration in managing obstetric emergencies such as crisis bleeding. Prompt clinical judgment and coordinated interventions involving various departments are emphasized for the well‐being of both the mother and newborn. The review explores the importance of emergency response infrastructure in obstetric facilities and delves into the 2022 Obstetric Crisis Bleeding Guidelines, emphasizing the relevance of a DIC score for severity assessment. The collaborative efforts within the operating room, involving different healthcare professionals, are detailed, stressing meticulous coordination during emergencies like massive bleeding. The necessity of interprofessional collaboration for building a responsive perioperative management team is discussed, with a focus on leadership, followership, and effective communication. The abstract also proposes simulation‐based education for inter‐departmental training, emphasizing a modified non‐technical skill evaluation tool tailored to the unique characteristics of obstetric crisis management in the operating room. Continuous formative assessment of these factors is deemed essential for effective training in various obstetric emergency situations.

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“…Importantly, 90% of condom catheter patients were given prophylactic antibiotics in the immediate postpartum period; the low rate of postpartum endometritis in the condom catheter patients could very well be explained by the high rate of prophylactic antibiotic administration 53 . As the intrauterine vacuum-induced hemorrhage-control balloons are new to the market, there are no studies exploring infectious risk 54 …”

Section: Exploration and Instrumentation Of The Postpartum Uterusmentioning

confidence: 99%

“…53 As the intrauterine vacuum-induced hemorrhage-control balloons are new to the market, there are no studies exploring infectious risk. 54 Various studies have analyzed the impact of antibiotics on decreasing the risk of endometritis following intrauterine balloon tamponade. In the Japanese retrospective cohort mentioned previously, researchers found that a single dose of prophylactic ampicillin 2 g IV or cefazolin 1 g IV in vaginal deliveries requiring Bakri balloon placement was associated with a decreased risk of endometritis.…”

Section: Intrauterine Tamponade Balloonmentioning

confidence: 99%

Antibiotic Recommendations After Postpartum Uterine Exploration or Instrumentation

Lambert

Honart

Hughes

et al. 2023

Obstetrical &Amp; Gynecological Survey

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Importance Multiple postpartum scenarios require uterine exploration or instrumentation. These may introduce bacteria into the uterus, increasing the risk of endometritis. Data on the use of antibiotics in these scenarios is limited, resulting in few guidelines and divergent care. Objective To describe postpartum scenarios requiring uterine exploration and/or instrumentation, review data on antibiotic prophylaxis, and delineate antibiotic recommendations for each scenario. Evidence Acquisition Original articles were obtained from literature search in PubMed, MEDLINE, and OVID; pertinent articles were reviewed. Results These recommendations are based on published evidence and professional society guidelines. Antibiotic prophylaxis following manual placenta removal should include 1-time combination of ampicillin 2 g intravenously (IV) or cefazolin 1 g IV, plus metronidazole 500 mg IV. Antibiotic prophylaxis before postpartum dilation and curettage, manual vacuum aspiration, and intrauterine balloon tamponade should include 1-time combination of ampicillin 2 g IV plus metronidazole 500 mg IV. If the patient in any of the above scenarios has received group B Streptococcus prophylaxis, then only metronidazole is recommended. Further randomized clinical trials are needed to optimize these regimens. Conclusions Uterine exploration or instrumentation increases the risk of postpartum endometritis and requires antibiotic prophylaxis. For manual placenta removal, we recommend 1-time combination of ampicillin 2 g IV or cefazolin 1 g IV, plus metronidazole 500 mg IV. For dilation and curettage, manual vacuum aspiration, and intrauterine balloon tamponade, we recommend 1-time combination of ampicillin 2 g IV plus metronidazole 500 mg IV. For patients who already received antibiotic prophylaxis for group B Streptococcus, we recommend 1-time dose of metronidazole 500 mg IV. Relevance Providers can utilize our guidelines to prevent postpartum endometritis in these scenarios requiring postpartum uterine exploration and/or instrumentation. Target Audience Obstetricians and gynecologists, family physicians Learning Objectives After reading this article, the provider should be better able to discuss diagnosis and management of endometritis; describe antibiotic regimens recommended in the setting of uterine exploration postpartum; and identify antibiotic regimens recommended in the setting of postpartum uterine instrumentation.

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Traditional uterine tamponade and vacuum-induced uterine tamponade devices in obstetrical hemorrhage management

Cited by 10 publications

References 26 publications

Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device

Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device

Significance of perioperative inter‐departmental collaboration for obstetric emergency response: A mini‐review

Antibiotic Recommendations After Postpartum Uterine Exploration or Instrumentation

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