Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Aug 15:3:100.
doi: 10.12688/wellcomeopenres.14722.1. eCollection 2018.

Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial

Haleema Shakur-Still  1 , Ian Roberts  1 , Bukola Fawole  2 , Modupe Kuti  3 , Oladapo O Olayemi  4 , Adenike Bello  4 , Sumaya Huque  1 , Olayinka Ogunbode  4 , Taiwo Kotila  5 , Chris Aimakhu  4 , Olujide A Okunade  2 , Tolulase Olutogun  5 , Cecilia O Adetayo  2 , Kastriot Dallaku  6   7 , Ulrich Mansmann  7 , Beverley J Hunt  8 , Tracey Pepple  1 , Eni Balogun  1
Affiliations

Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial

Haleema Shakur-Still et al. Wellcome Open Res. .

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).

Keywords: Coagulation; Fibrinolysis; Postpartum Haemorrhage; Randomised Controlled Trial; Thromboelastogram; Tranexamic Acid.

PubMed Disclaimer

Conflict of interest statement

No competing interests were disclosed.

Figures

Figure 1.
Figure 1.. Consort diagram.
Figure 2.
Figure 2.. Forest plot of the effect of tranexamic acid (TXA) on D-dimer values in women with postpartum haemorrhage.
See this image and copyright information in PMC

References

    1. World Health Organisation: WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. WHO. Geneva.2012. Reference Source - PubMed
    1. Carroli G, Cuesta C, Abalos E, et al. : Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol. 2008;22(6):999–1012. 10.1016/j.bpobgyn.2008.08.004 - DOI - PubMed
    1. WHO, UNFPA and The World Bank: Trends in maternal mortality: 1990 to 2010 - WHO, UNICEF, UNFPA and The World Bank estimates.2012. Reference Source
    1. Ronsmans C, Graham WJ, Lancet Maternal Survival Series steering group: Maternal mortality: who, when, where, and why. Lancet. 2006;368(9542):1189–200. 10.1016/S0140-6736(06)69380-X - DOI - PubMed
    1. Say L, Chou D, Gemmill A, et al. : Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):e323–33. 10.1016/S2214-109X(14)70227-X - DOI - PubMed

LinkOut - more resources