Abstract
Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. The WOMAN trial showed that tranexamic acid (TXA) reduces death due to bleeding in women with PPH. We evaluated the effect of TXA on fibrinolysis and coagulation in a sample of WOMAN trial participants. Methods: Adult women with a clinical diagnosis of PPH were randomised to receive 1 g TXA or matching placebo in the WOMAN trial. Participants in the WOMAN trial at University College Hospital (Ibadan, Nigeria) also had venous blood taken just before administration of the first dose of trial treatment and again 30 (±15) min after the first dose (the ETAC study). We aimed to determine the effects of TXA on fibrinolysis (D-dimer and rotational thromboelastometry maximum clot lysis (ML)) and coagulation (international normalized ratio and clot amplitude at 5 min). We compared outcomes in women receiving TXA and placebo using linear regression, adjusting for baseline measurements. Results: Women (n=167) were randomised to receive TXA (n=83) or matching placebo (n=84). Due to missing data, seven women were excluded from analysis. The mean (SD) D-dimer concentration was 7.1 (7.0) mg/l in TXA-treated women and 9.6 (8.6) mg/l in placebo-treated women (p=0.09). After adjusting for baseline, the D-dimer concentration was 2.16 mg/l lower in TXA-treated women (-2.16, 95% CI -4.31 to 0.00, p=0.05). There was no significant difference in ML between TXA- and placebo-treated women (12.3% (18.4) and 10.7% (12.6), respectively; p=0.52) and no significant difference after adjusting for baseline ML (1.02, 95% CI -3.72 to 5.77, p=0.67). There were no significant effects of TXA on any other parameters. Conclusion: TXA treatment was associated with reduced D-dimer levels but had no apparent effects on thromboelastometry parameters or coagulation tests. Registration: ISRCTN76912190 (initially registered 10/12/2008, WOMAN-ETAC included on 22/03/2012) and NCT00872469 (initially registered 31/03/2009, WOMAN-ETAC included on 22/03/2012).
Highlights
Primary postpartum haemorrhage (PPH) is the leading cause of maternal death worldwide, responsible for an estimated 100,000 deaths each year[1,2,3]
tranexamic acid (TXA) treatment was associated with reduced D-dimer levels but had no apparent effects on thromboelastometry parameters or coagulation tests
The WOMAN trial showed that TXA reduces death due to bleeding in women with PPH by about one-fifth
Summary
Primary postpartum haemorrhage (PPH) is the leading cause of maternal death worldwide, responsible for an estimated 100,000 deaths each year[1,2,3]. The WOMAN trial showed that TXA reduces death due to bleeding in women with PPH by about one-fifth. When given within 3 hours of giving birth it reduces maternal death due to bleeding by around one-third[7]. Within an hour of giving birth, there is a doubling of the plasma concentration of tissue plasminogen activator[10]. While it is true that coagulation parameters are affected after childbirth, as described, the wrong citation is provided for the statement 'within an hour of giving birth, there is a doubling of the plasma concentration of tissue plasminogen activator'. The WOMAN trial showed that tranexamic acid (TXA) reduces death due to bleeding in women with PPH. Methods: Adult women with a clinical diagnosis of PPH were randomised to receive 1 g TXA or matching placebo in the WOMAN trial.
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