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01.12.2016 | Update | Ausgabe 1/2016 Open Access

Trials 1/2016

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

Zeitschrift:
Trials > Ausgabe 1/2016
Autoren:
Haleema Shakur, Ian Roberts, Philip Edwards, Diana Elbourne, Zarko Alfirevic, Carine Ronsmans
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-016-1332-2) contains supplementary material, which is available to authorized users.
This reply refers to the comment available at: http://​dx.​doi.​org/​10.​1186/​1745-6215-11-40.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

The WOMAN Trial was conceived by IR and HS, and all authors contributed to its design. This manuscript detailing the statistical plan was drafted by HS, IR and PE. DE. ZA and CR reviewed and commented on it. All authors reviewed and agreed on the final manuscript.

Abstract

Background

Severe haemorrhage is a leading cause of maternal death worldwide. Most haemorrhage deaths occur soon after childbirth. Severe post-partum bleeding is sometimes managed by the surgical removal of the uterus (hysterectomy). Death and hysterectomy are important health consequences of post-partum haemorrhage, and clinical trials of interventions aimed at preventing these outcomes are needed.

Methods

The World Maternal Antifibrinolytic trial aims to determine the effect of tranexamic acid on death, hysterectomy and other health outcomes in women with post-partum haemorrhage. It is an international, multicentre, randomised trial. Approximately 20,000 women with post-partum haemorrhage will be randomly allocated to receive an intravenous injection of either tranexamic acid or matching placebo in addition to usual care. The primary outcome measure is a composite of death in hospital or hysterectomy within 42 days of delivery. The cause of death will be described. Secondary outcomes include death, death due to bleeding, hysterectomy, thromboembolic events, blood transfusion, surgical and radiological interventions, complications, adverse events and quality of life. The health status and occurrence of thromboembolic events in breastfed babies will also be reported. We will conduct subgroup analyses for the primary outcome by time to treatment, type of delivery and cause of haemorrhage. We will conduct an analysis of treatment effect adjusted for baseline risk.

Discussion

The World Maternal Antifibrinolytic trial should provide reliable evidence for the efficacy of tranexamic acid in the prevention of death, hysterectomy and other outcomes that are important to patients. We present a protocol update and the statistical analysis plan for the trial.

Trial registration

Current Controlled Trials ISRCTN76912190 (Registration date 08 December 2008), Clinicaltrials.gov NCT00872469 (Registration date 30 March 2009) and Pan African Clinical Trials Registry: PACTR20100700019​2283 (Registration date 02 September 2010).
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