Medicine by the Numbers
A Collaboration of TheNNT.com and AFP
Tranexamic Acid for Postpartum Hemorrhage
Am Fam Physician. 2020 May 1;101(9):online.
Details for This Review
Study Population: 20,060 females 16 years and older with clinical diagnosis of postpartum hemorrhage after vaginal birth or cesarean delivery
Efficacy End Points: Reduction in deaths from all causes, death from bleeding, or hysterectomy
Harm End Points: Thromboembolic events and organ failure
Narrative: Postpartum hemorrhage (PPH) is the most common cause of maternal death worldwide. Tranexamic acid (Cyklokapron) is an antifibrinolytic agent that has been shown to decrease bleeding in surgical patients and all-cause death in trauma patients.1,2 In 2012, tranexamic acid was incorporated into the World Health Organization (WHO) guidelines for refractory or trauma-related PPH.3
The WOMAN trial was a single randomized, double-blind, placebo-controlled, multicenter international study consisting of 20,060 females 16 years and older with a diagnosis of PPH after vaginal birth or cesarean delivery.4 It investigated whether early administration of tranexamic acid reduced the rates of death and hysterectomy in patients with PPH compared with placebo. Outcomes were measured at hospital discharge or on day 42 if the patient was still hospitalized.
Administration of tranexamic acid did not reduce all-cause mortality. However, tranexamic acid showed a reduction in the risk of death due to bleeding (relative risk [RR] = 0.81; 95% CI, 0.62 to 0.98; 0.4% absolute risk difference [ARD]; number needed to treat [NNT] = 267; very low-quality evidence). There was no difference in hysterectomy rate between the two groups.
There was no difference between tranexamic acid and placebo in the rate of thromboembolic events (deep venous thrombosis, pulmonary embolism, myocardial infarction, and stroke), organ failure (renal, cardiac, respiratory), or sepsis and use of uterotonics.
A systematic review and meta-analysis,5 which only included patients with PPH following vaginal delivery and excluded cesarean deliveries (approximately 14,000
Referencesshow all references
1. Ker K, Prieto-Merino D, Roberts I. Systematic review, meta-analysis and meta-regression of the effect of tranexamic acid on surgical blood loss. Br J Surg. 2013;100(10):1271–1279....
2. Shakur H, Roberts I, Bautista R, et al.; CRASH-2 Trial Collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010;376(9374):23–32.
3. World Health Organization. WHO recommendations on prevention and treatment of postpartum haemorrhage and the WOMAN trial. World Health Organization, 2017. Accessed August 6, 2019. https://www.who.int/reproductivehealth/topics/maternal_perinatal/pph-woman-trial/en/
4. 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.
5. Della Corte L, Saccone G, Locci M, et al. Tranexamic acid for treatment of primary postpartum hemorrhage after vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. . 2018:1–6.
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