Requiring a second-line uterotonic treatment with sulprostone (E1 prostaglandin)
Sulprostone infusion combined with within 15 minutes of randomization
Uterotonic then balloon tamponade
Sulprostone infusion alone within 15 minutes of randomization
If bleeding persisted ≥30 minutes, balloon tamponade performed
Ebb double balloon system: Fill capacity of up to 750 mL
If the bleeding persisted ≥30 minutes after the balloon insertion, an emergency radiological or surgical invasive procedure was performed
Transfusion of ≥3 units of packed red blood cells or
Calculated peripartum blood loss >1000 mL
Calculated blood loss of ≥1500 mL
An invasive procedure
Transfer to the intensive care unit
Concurrent: 199 women | Uterotonic then balloon: 193 women
Baseline characteristics were similar for both groups
There was no difference in the primary outcome between the groups
Concurrent: 67.2% | Uterotonic then balloon: 74.3%
Risk ratio: RR 0.90 (95% CI, 0.79 to 1.03)
The groups did not differ for the following rates
Peripartum blood loss ≥1500 mL | Any transfusion | Invasive procedure | Admission to ICU
There was a trend towards increased rates of endometritis in the concurrent group (underpowered)
Concurrent: 2.7% | Uterotonic then balloon: 0%
There was no difference in severe postpartum hemorrhage events when balloon tamponade was initiated with second-line uterotonics vs standard care where balloon tamponade is follows failure of second-line uterotonics
The authors state that use of balloon tamponade
… immediately after the failure of second-line uterotonic treatment seems to be the best minimally invasive option for controlling hemorrhage
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