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
. 2023 May 12:7:3.
doi: 10.12688/gatesopenres.13747.2. eCollection 2023.

Tranexamic acid for the prevention of postpartum bleeding: Protocol for a systematic review and individual patient data meta-analysis

Anti-fibrinolytics Trialists Collaborators – Obstetric Trialists Group; Katharine Ker  1 , Haleema Shakur-Still  1 , Loïc Sentilhes  2 , Luis D Pacheco  3 , George Saade  4 , Catherine Deneux-Tharaux  5 , Amy Brenner  1 , Raoul Mansukhani  1 , François-Xavier Ageron  6 , Danielle Prowse  1 , Rizwana Chaudhri  7 , Oladapo Olayemi  8 , Ian Roberts  1
Affiliations

Tranexamic acid for the prevention of postpartum bleeding: Protocol for a systematic review and individual patient data meta-analysis

Anti-fibrinolytics Trialists Collaborators – Obstetric Trialists Group et al. Gates Open Res. .

Abstract

Tranexamic acid (TXA) reduces the risk of death and is recommended as a treatment for women with severe postpartum bleeding. There is hope that giving TXA shortly before or immediately after birth could prevent postpartum bleeding. Extending the use of TXA to prevent harmful postpartum bleeding could improve outcomes for millions of women; however we must carefully consider the balance of benefits and potential harms. This article describes the protocol for a systematic review and individual patient data (IPD) meta-analysis to assess the effectiveness and safety of TXA for preventing postpartum bleeding in all women giving birth, and to explore how the effects vary by underlying risk and other patient characteristics. Methods: We will search for prospectively registered, randomised controlled trials involving 500 patients or more assessing the effects of TXA in women giving birth. Two authors will extract data and assess risk of bias. IPD data will be sought from eligible trials. Primary outcomes will be life-threatening bleeding and thromboembolic events. We will use a one-stage model to analyse the data. Subgroup analyses will be conducted to explore whether the effectiveness and safety of TXA varies by underlying risk, type birth, maternal haemoglobin (Hb), and timing of TXA. This protocol is registered on PROSPERO (CRD42022345775). Conclusions: This systematic review and IPD meta-analysis will address important clinical questions about the effectiveness and safety of the use of TXA for the prevention of postpartum bleeding that cannot be answered reliably using aggregate data and will inform the decision of who to treat. PROSPERO registration: CRD42022345775 Keywords Anti-fibrinolytics; Tranexamic acid; childbirth; postpartum haemorrhage; meta-analysis.

Keywords: Anti-fibrinolytics; Tranexamic acid; childbirth; meta-analysis; postpartum haemorrhage.

PubMed Disclaimer

Conflict of interest statement

Competing interests: LS reports receiving lecture and consulting fees from Ferring. No competing interests were disclosed for any other author.

Figures

Figure 1.
Figure 1.. How the potential benefit and harm of a treatment varies by baseline risk.
Adapted from Glasziou and Irwig .
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Say L, Chou D, Gemmill A, et al. : Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):e323–333. 10.1016/S2214-109X(14)70227-X - DOI - PubMed
    1. Say L, Pattinson R, Gülmezoglu A: WHO systematic review of maternal morbidity and mortality: the prevalence of severe acute maternal morbidity (near miss). Reprod Health. BioMed Central,2004;1(1):3. 10.1186/1742-4755-1-3 - DOI - PMC - PubMed
    1. Knight M, Bunch K, Tuffnell D, et al. : Saving Lives, Improving Mothers’ Care. Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2017-19.Oxford: National Perinatal Epidemiology Unit, University of Oxford,2021. Reference Source
    1. Woman Trial Collaborators: Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017;389(10084):2105–2116. 10.1016/S0140-6736(17)30638-4 - DOI - PMC - PubMed
    1. Thompson JF, Heal LJ, Roberts CL, et al. : Women's breastfeeding experiences following a significant primary postpartum haemorrhage: A multicentre cohort study. Int Breastfeed J. 2010;5:5. 10.1186/1746-4358-5-5 - DOI - PMC - PubMed

LinkOut - more resources