Table 1.
Baseline characteristics of participants before randomisation
| Tranexamic acid group (n=10 051) | Placebo group (n=10 009) | |
|---|---|---|
| Age at randomisation (years) | ||
| <16 | 1 (<1%) | 3 (<1%) |
| 16–25 | 3445 (34%) | 3407 (34%) |
| 26–33 | 4580 (46%) | 4608 (46%) |
| ≥34 | 2022 (20%) | 1987 (20%) |
| Unknown | 3 (<1%) | 4 (<1%) |
| Baby delivered in the randomising hospital | ||
| Yes | 8869 (88%) | 8756 (88%) |
| No | 1181 (12%) | 1251 (13%) |
| Unknown | 1 (<1%) | 2 (<1%) |
| Type of delivery | ||
| Vaginal | 7093 (71%) | 7126 (71%) |
| Caesarean section | 2957 (29%) | 2879 (29%) |
| Unknown | 1 (<1%) | 4 (<1%) |
| Time between delivery and randomisation (h) | ||
| ≤1 | 4852 (48%) | 4733 (47%) |
| >1 to ≤3 | 2678 (27%) | 2691 (27%) |
| >3 | 2517 (25%) | 2574 (26%) |
| Unknown | 4 (<1%) | 11 (<1%) |
| Placenta fully delivered | ||
| Yes | 9089 (90%) | 9016 (90%) |
| No | 962 (10%) | 990 (10%) |
| Primary cause of haemorrhage | ||
| Uterine atony | 6437 (64%) | 6347 (63%) |
| Placenta praevia or accreta | 943 (9%) | 935 (9%) |
| Surgical trauma or tears | 1834 (18%) | 1857 (19%) |
| Other | 720 (7%) | 737 (7%) |
| Unknown | 117 (1%) | 133 (1%) |
| Systolic blood pressure (mm Hg) | ||
| ≥90 | 8138 (81%) | 8065 (81%) |
| <90 | 1908 (19%) | 1929 (19%) |
| Unknown | 5 (<1%) | 15 (<1%) |
| Estimated volume of blood lost (mL) | ||
| ≤500 | 295 (3%) | 313 (3%) |
| >500 to ≤1000 | 4949 (49%) | 4861 (49%) |
| >1000 to ≤1500 | 2832 (28%) | 2882 (29%) |
| >1500 | 1973 (20%) | 1953 (20%) |
| Unknown | 2 (<1%) | 0 |
| Uterotonic prophylaxis given | ||
| Yes | 9687 (96%) | 9618 (96%) |
| No | 131 (1%) | 139 (1%) |
| Unknown | 233 (2%) | 252 (3%) |
| Clinical signs of haemodynamic instability | ||
| Yes | 5961 (59%) | 5898 (59%) |
| No | 4090 (41%) | 4110 (41%) |