Characteristics
Fibrinogen N=224 Placebo N=213
Age, mean ± SD, years 30.5 ± 5.6 30.3 ± 5.4
Weight before pregnancy, mean ± SD, kg 65.2 ± 13.9 65.5 ± 14.8
Weight (last known), mean ± SD, kg 77.6 ± 13.6 77.8 ± 13.7
Height, mean ± SD, cm 165.8 ± 5.8 165.8 ± 6.5
Parity, N (%)
Primiparous
113 (50.4%)
96 (45.1%)
Multiparous
111 (49.6%)
117 (54.9%)
Multiple pregnancy, N (%) 25 (11.2%) 24 (11.3%)
Term, mean ± SD, weeks 39.2 ± 1.9 38.9 ± 2.3
Prepartum Hb level, mean ± SD, g/dL 11.8 ± 1.0 11.9 ± 0.9
Induction of labor, N (%) 88 (39.3%) 65 (30.5%)
Instrumental vaginal delivery, N (%) 54 (24.1%) 43 (20.2%)
Cause of PPH, N (%)
Atony
179 (79.9%)
182 (85.4%)
Placenta retention
67 (29.9%)
52 (24.4%)
Lower genital tract wound
19 (8.5%)
19 (8.9%)
Other
8 (3.6%)
1 (0.5%)
Time from…, mean ± SD, min
Delivery to start of bleeding
41.2 ± 57.4
38.5 ± 58.4
Delivery to start of sulprostone administration
73.8 ± 70.5
74.7 ± 116.5
Delivery to start of study drug infusion
92.0 ± 70.8
85.2 ± 65.9
Prior Tranexamic Acid
N (%) 107 (47.8%) 102 (47.9%)
Mean ± SD, g 1.1 ± 0.3 1.1 ± 0.3
Estimated blood loss at the start of prostaglandin infusion, mean (SD), mL 896 ± 373 857 ± 315
Plasma Fibrinogen level at inclusion, mean ± SD, g/L 4.2 ± 0.9 4.0 ± 1.0
N (%)
≤ 2 g/L
2 (1.0%)
3 (1.5%)
]2; 3] g/L
19 (9.1%)
21 (10.8%)
]3-4] g/L
62 (29.7%)
75 (38.5%)
> 4 g/L
126 (60.3%)
96 (49.2%)