Persistent PPH after vaginal delivery requiring a switch from oxytocin to prostaglandins
3 g fibrinogen concentrate within 30 min after introduction of prostaglandins
Sample size analysis
Power: 90% at the 2-sided significance level of 0.05
Assumptions: Expected failure rates of 42% in placebo group and 27% in fibrinogen group (15% absolute difference)
434 participants required (assumed 5% drop out rate | Study stopped early as drop out rate was only 1.55% in an interim analysis
Treatment Failure: At least 4 g/dL of hemoglobin decrease and/or transfusion of at least 2 units of packed red blood cells within 48 hours following intervention
Need for hemostatic procedures
Maternal morbidity-mortality within 6±2 weeks after delivery
Fibrinogen: 224 patients | Placebo: 213
At inclusion, blood loss (877 mL) and plasma fibrinogen levels (4.1 g/L) were similar between both groups
Primary outcome: After adjustment for center and baseline plasma fibrinogen, there was no significant difference in failure rates between the fibrinogen vs placebo groups
OR 0.99 (95% CI, 0.66 to 1.47; P = 0.96)
No significant differences in secondary efficacy outcomes were observed
Mean plasma fibrinogen decreased in the placebo group and was unchanged in the fibrinogen group
Placebo: -0.56 g/L
Thromboembolic or other adverse effects
Placebo: 2 events
Early, systematic administration of fibrinogen to treat PPH did not result in a significant difference in blood loss, transfusion, and postpartum anemia vs placebo
Fibrinogen administration did prevent plasma fibrinogen decrease without any subsequent adverse events
The authors conclude that
As judged by the findings of the present study and in line with those of previous placebo-controlled studies, the use of fibrinogen concentrate in a routine blind and systematic setting for PPH cannot be recommended
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