(68) Prospective multicenter trial comparing balloon versus suction hemorrhage control devices for postpartum hemorrhage

Objective: Postpartum hemorrhage (PPH) is the leading cause of severe maternal morbidity. Two devices, balloon (Bakri) and suction (Jada), are available for treatment of PPH, but there is limited data directly comparing their efficacy against each other. The purpose of this study was to prospectively compare these two devices within a large multi-center hospital system using a standardized 3 stage PPH response algorithm.

Study

Design: PPH and use of hemorrhage control devices was assessed at 65 facilities through detailed case audits. Use of PPH control devices is recommended for stages 2 and 3 of the algorithm. Case audits included all cases of stage 3 PPH, if a PPH device was used, or there was transfusion. The primary outcomes were: 1) need for any transfusion; 2) use of ³ 3 units of red blood cells (pRBC); and 3) quantitative blood loss (QBL) after device placement. Other variables assessed were length of stay (LOS), mode of delivery, admission Hct, abnormal DIC labs (INR, platelets, and fibrinogen), use of tranexamic acid (TXA), and discharge Hct. Data was analyzed using t-test and z-ratios.


Results: During the 11-month observation period there was 80,049 deliveries and PHH occurred in 3,894 (4.9%). PPH control devices (Bakri, n=183 and Jada, n=195) were used in 378 cases (10.3%). The Bakri group had a higher rate of cesarean delivery (36.1% v. 25.1%, p=0.02), rate of abnormal DIC panel (29.2% v. 16.8%, p< 0.01), and a higher QBL at time of device placement (1729 v 1538 ml, p=0.01). There was no difference between devices for Hct at admission, use of TXA, QBL after device placement, rate of transfusion, the number requiring ³ 3 units of pRBC, or discharge Hct, Table 1.


Conclusion: Despite higher QBL at placement, abnormal DIC labs, and the rate of cesarean section in the Bakri group both devices were equally effective with regards to mitigating transfusion requirements and blood loss after device placement. With similar efficacy when used as part of a standardized PPH response other factors, such as cost of the device, availability and ease of use, will need to be considered.