Abstract | BACKGROUND: In severe post-partum haemorrhage, death can occur within hours of bleeding onset so interventions to control the bleeding must be given immediately. In clinical trials of treatments for life-threatening bleeding, established treatments are given priority and the trial treatment is usually given last. However, enrolling patients in whom severe maternal morbidity or death is imminent or inevitable at the time of randomisation may dilute the effects of a trial treatment. METHODS: We conducted an exploratory analysis of data from the WOMAN trial, an international, randomised placebo-controlled trial of the effects of tranexamic acid on death and surgical intervention in 20,060 women with post-partum haemorrhage. We assessed the impact of early maternal death or hysterectomy due to exsanguination on the effect of tranexamic acid on each of these respective outcomes. We conducted repeated analyses excluding patients with these outcomes at increasing intervals from the time of randomisation. We quantified treatment effects using risk ratios (RR) and 99% confidence intervals (CI) and prepared cumulative failure plots. RESULTS: CONCLUSIONS: TRIAL REGISTRATION: ISRCTN trial registration number ISRCTN76912190, 8 Dec 2008; ClinicalTrials.gov number NCT00872469, 30 March 2009; PACTR number PACTR201007000192283, 9 Feb 2010; EudraCT number 2008-008441-38, 8 Dec 2010 (retrospectively registered).
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Authors | Amy Brenner, Haleema Shakur-Still, Rizwana Chaudhri, Bukola Fawole, Sabaratnam Arulkumaran, Ian Roberts, WOMAN Trial Collaborators |
Journal | BMC pregnancy and childbirth
(BMC Pregnancy Childbirth)
Vol. 18
Issue 1
Pg. 215
(Jun 07 2018)
ISSN: 1471-2393 [Electronic] England |
PMID | 29879947
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antifibrinolytic Agents
- Tranexamic Acid
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Topics |
- Adult
- Antifibrinolytic Agents
(administration & dosage)
- Female
- Humans
- Hysterectomy
(statistics & numerical data)
- Maternal Death
(prevention & control)
- Odds Ratio
- Postpartum Hemorrhage
(drug therapy, surgery)
- Pregnancy
- Time Factors
- Tranexamic Acid
(administration & dosage)
- Treatment Outcome
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