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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