Primary outcome |
Failure, N (%) |
88 (40.0%) |
89 (42.4%) |
0.99 [0.66; 1.47] |
0.96* |
Secondary outcomes |
RBC Transfusion ≥ 2 Units from H0 to D2, N
(%) |
51 (23.4%) |
52 (25.0%) |
1.00 [0.63; 1.60] |
0.98* |
|
RBC Transfusion ≥ 4 Units from H0 to D2, N (%) |
6 (2.7%) |
5
(2.4%) |
|
0.87#
|
|
Number of RBC units per transfused patient from H0 to D2, mean ±SD |
2.7 ± 1.2 |
3.1 ± 2.5 |
|
0.99£
|
|
Hb loss ≥ 4 g/dL from reference level to D2, N (%) |
42 (19.1%) |
41
(19.5%) |
1.02 [0.62;1.67] |
0.95* |
|
Hb loss ≥ 3 g/dL from reference level to D2, N (%) |
102 (46.4%) |
98 (46.9%) |
|
0.91#
|
|
Hb loss ≥ 4 g/dL from H0 to D2, N (%) |
16 (7.3%) |
17 (8.3%) |
|
0.69#
|
|
Hb level < 9 g/dL from reference level to D2, N (%) |
112
(50.9%) |
117 (56.0%) |
|
0.29#
|
|
Total blood loss (from baseline to D2), mean ± SD, mL |
1555 ± 849 |
1723 ± 1193 |
|
0.21£
|
|
Additional blood loss (from H0 to D2), mean ± SD, mL |
304.7 ± 386.2 |
319.7 ± 417.1 |
|
0.33£
|
|
Intrauterine balloon, N (%) |
63 (28.6%) |
61 (29.0%) |
|
0.93#
|
|
At least one rescue procedure, N (%) |
65 (29.5%) |
64 (30.5%) |
|
0.83#
|
|
At least one invasive hemostatic procedure, N (%), including: |
8
(3.6%) |
10 (4.8%) |
|
0.56#
|
|
Arterial embolization |
6 (2.7%) |
10 (4.8%) |
|
0.27#
|
|
Arterial ligation |
0 (0%) |
0 (0%) |
|
- |
|
Hysterectomy |
0 (0%) |
1 (0.5%) |
|
0.49$ |
|
Intensive care or resuscitation, N (%) |
62 (28.2%) |
54 (25.7%) |
|
0.56#
|
|
Length of stay in intensive care or resuscitation unit, mean ± SD, day |
0.7 ± 0.6 |
0.7 ± 0.9 |
|
0.84£
|
|
SOFA score of patients admitted to intensive care or resuscitation
unit, median [min; max] |
0 [0;4] |
0 [0;6] |
|
0.32£
|
|
Death, N (%) |
0 (0%) |
0 (0%) |
|
- |