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Table 1 Baseline characteristics of participants prior to randomisation

From: The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial

  Tranexamic acid Placebo
(n = 10,000) (n = 10,000)
Age at randomisation (years):   
 < 16 N (X %) N (X %)
 16–25 N NNN (X %) N NNN (X %)
 26–33 N NNN (X %) N NNN (X %)
 34+ N NNN (X %) N NNN (X %)
 Baby delivered in this hospital N NNN (X %) N NNN (X %)
Type of delivery:   
 Vaginal N NNN (X %) N NNN (X %)
 Caesarean section N NNN (X %) N NNN (X %)
Time between delivery and randomisation (hours):   
 ≤ 1 N NNN (X %) N NNN (X %)
 > 1 to ≤ 3 N NNN (X %) N NNN (X %)
 > 3a N NNN (X %) N NNN (X %)
Placenta fully delivered:   
 Yes N NNN (X %) N NNN (X %)
 No NNN (X %) NNN (X %)
Primary cause of haemorrhage:   
 Uterine atony N NNN (X %) N NNN (X %)
 Placenta praevia/accreta N NNN (X %) N NNN (X %)
 Surgical trauma/tears N NNN (X %) N NNN (X %)
 Other N NNN (X %) N NNN (X %)
 Unknown N NNN (X %) N NNN (X %)
Systolic BP (mmHg):   
 ≥ 90 N NNN (X %) N NNN (X %)
 < 90 N NNN (X %) N NNN (X %)
Estimated volume of blood lost (mL):   
 ≤ 500 N NNN (X %) N NNN (X %)
 > 500 to ≤ 1000 N NNN (X %) N NNN (X %)
 > 1000 N NNN (X %) N NNN (X %)
Uterotonic prophylaxis given:   
 Yes N NNN (X %) N NNN (X %)
 No N NNN (X %) N NNN (X %)
 Not known N NNN (X %) N NNN (X %)
Clinical signs of haemodynamic instability:   
 Yes N NNN (X %) N NNN (X %)
 No N NNN (X %) N NNN (X %)
  1. aIncludes X patients randomly assigned more than 24 h after delivery