Vacuum-assisted hemorrhage control device versus uterine balloon tamponade for refractory atonic postpartum hemorrhage in a protocol-driven care pathway-A retrospective cohort study.

INTRODUCTION: Globally, 1 in 5 maternal deaths are attributable to major postpartum hemorrhage (PPH), despite widespread uterotonic use. Intrauterine tamponade is recommended as second-line therapy for refractory atonic PPH. Uterine balloon tamponade (UBT) achieves hemostasis through intrauterine pressure. Conversely, the vacuum-assisted hemorrhage-control device (VHD) promotes uterine contraction through negative pressure. Limited data compare these modalities. We compared the clinical effectiveness of UBT and VHD in refractory atonic PPH. MATERIAL AND METHODS: This retrospective cohort study was conducted at the National University Hospital in Singapore and included all women treated for primary PPH with either the UBT or VHD between January 2020 and September 2025, during which ROTEM-guided transfusion and E-MOTIVE-aligned practices were implemented. The composite morbidity endpoint, comprising transfusion of ≥4 units of packed red blood cells (PRBC), plasma or cryoprecipitate administration, examination under anesthesia, high dependency or intensive care unit admission, or device failure was compared between groups with logistic regression adjusted for placenta previa major and cesarean delivery. RESULTS: Fifty-three women met inclusion criteria (33 UBT, 20 VHD). The composite morbidity outcome occurred less frequently with VHD than UBT (45.0% versus 75.8%; unadjusted OR 0.26, 95% CI 0.08-0.86, p = 0.03); after adjusting for placenta previa major and cesarean delivery, this difference was no longer statistically significant (adjusted OR 0.38, 95% CI 0.10-1.41, p = 0.15). Baseline characteristics were similar except for higher rates of placenta previa (45.5% versus 5.0%) and cesarean delivery (78.8% versus 50.0%) in the UBT group. Median estimated blood loss at device insertion was comparable (1500 mL). Among secondary outcomes, VHD was associated with lower median PRBC transfusion (1 vs. 2 units, p = 0.009), fewer women receiving ≥4 PRBC units (5.0% versus 36.4%, p = 0.02), fewer plasma transfusions (5.0% versus 36.4%, p = 0.02), shorter device indwelling duration (10.1 versus 24.3 h, p < 0.001), shorter hospital stay (54 versus 72 h, p = 0.007), and fewer high-dependency admissions (45.0% versus 72.7%, p = 0.04). CONCLUSIONS: The VHD demonstrated outcomes comparable to balloon tamponade in managing refractory atonic PPH, with lower transfusion requirements and shorter hospitalization. VHD may be a useful component of standardized PPH protocols incorporating the E-MOTIVE bundle and ROTEM-guided transfusion, warranting further evaluation in broader clinical settings.