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. 2018 Dec 29;19(1):712.
doi: 10.1186/s13063-018-3081-x.

Tranexamic acid for the prevention of postpartum bleeding in women with anaemia: study protocol for an international, randomised, double-blind, placebo-controlled trial

Katharine Ker  1 , Ian Roberts  1 , Rizwana Chaudhri  2 , Bukola Fawole  3 , Danielle Beaumont  1 , Eni Balogun  1 , Danielle Prowse  1 , Tracey Pepple  1 , Kiran Javaid  4 , Aasia Kayani  4 , Sabaratnam Arulkumaran  5 , Imelda Bates  6 , Haleema Shakur-Still  7 ; WOMAN-2 trial collaborators
Affiliations

Tranexamic acid for the prevention of postpartum bleeding in women with anaemia: study protocol for an international, randomised, double-blind, placebo-controlled trial

Katharine Ker et al. Trials. .

Abstract

Background: Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year, most of which occur in low- and middle-income countries. Tranexamic acid (TXA) reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. TXA decreases blood loss in surgery and reduces death due to bleeding after trauma. When given within 3 h of birth, TXA reduces deaths due to bleeding in women with PPH. However, for many women, treatment of PPH is too late to prevent death. Over one third of pregnant women in the world are anaemic and many are severely anaemic. These women have an increased risk of PPH and suffer more severe outcomes if PPH occurs. There is an urgent need to identify a safe and effective way to reduce postpartum bleeding in anaemic women.

Methods/design: The WOMAN-2 trial is an international, multicentre, randomised, double-blind, placebo-controlled trial to quantify the effects of TXA on postpartum bleeding in women with moderate or severe anaemia. Ten thousand women with moderate or severe anaemia who have given birth vaginally will be randomised to receive 1 g of TXA or matching placebo by intravenous injection immediately (within 15 min) after the umbilical cord is cut or clamped. The primary outcome is the proportion of women with a clinical diagnosis of primary PPH. The cause of PPH will be described. Data on maternal health and wellbeing, maternal blood loss and its consequences, and other health outcomes will be collected as secondary outcomes. The main analyses will be on an 'intention-to-treat' basis, irrespective of whether the allocated treatment was received. Results will be presented as appropriate effect estimates with a measure of precision (95% confidence intervals). Subgroup analyses will be based on the severity of anaemia (moderate versus severe) and type of labour (induced or augmented versus spontaneous). A study with 10,000 patients will have over 90% power to detect a 25% relative reduction from 10 to 7.5% in PPH. The trial will be conducted in hospitals in Africa and Asia.

Discussion: The WOMAN-2 trial should provide reliable evidence for the effects of TXA for preventing postpartum bleeding in women with anaemia.

Trial registration: ISRCTN, ISRCTN62396133 . Registered on 7 December 2017; ClincalTrials.gov, ID: NCT03475342 . Registered on 23 March 2018.

Keywords: Antifibrinolytic; Clinical trial; Maternal anaemia; Postpartum haemorrhage; Tranexamic acid.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics approval obtained from the London School of Hygiene and Tropical Medicine (ref: 15194).

Consent for publication

Not applicable – this manuscript does not contain any individual patient data.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Trial overview
Fig. 2
Fig. 2
Schedule of procedures, events and assessments
See this image and copyright information in PMC

References

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