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The cost-effectiveness of tranexamic acid for treatment of postpartum hemorrhage: A systematic review
Aziz S, Rossiter S, Homer CSE, Wilson AN, Comrie-Thomson L, Scott N, Vogel JP
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2021
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Editor's Choice
Abstract
BACKGROUND Postpartum hemorrhage (PPH) is responsible for nearly one quarter of maternal deaths. A 2017 multicountry trial found that incorporating tranexamic acid (TXA) into the PPH management package was effective in reducing maternal death due to bleeding. OBJECTIVE To systematically review studies assessing the cost-effectiveness of tranexamic acid for PPH treatment. SEARCH STRATEGY Nine databases were searched using variations of keywords 'tranexamic acid', 'postpartum hemorrhage' and 'cost effectiveness'. SELECTION CRITERIA Eligible studies were any type of economic or effectiveness evaluation studies on tranexamic acid for treating women with PPH. DATA COLLECTION AND ANALYSIS Two reviewers independently screened citations and extracted data on cost effectiveness measures. Quality was assessed using the Consensus on Health Economic Criteria list. MAIN RESULTS Four studies were included, of which two were abstracts. Three studies concluded that early administration of TXA was cost-saving or cost-effective. One abstract reported TXA was not cost-effective in the USA unless the probability of death due to hemorrhage is higher. CONCLUSION Available evidence (four studies in three countries) suggests that this life-saving intervention may be below willingness to pay thresholds (cost-effective) or cost saving. Further studies conducted in different populations and settings are needed to inform health policy decision-making to reduce PPH-associated morbidity and mortality.
PICO Summary
Population
Women with post-partum haemorrhage (PPH), (4 studies).
Intervention
Systematic review assessing the cost-effectiveness of tranexamic acid (TXA) for PPH treatment.
Comparison
Outcome
Three studies concluded that early administration of TXA was cost-saving or cost-effective. One abstract reported TXA was not cost-effective in the USA unless the probability of death due to haemorrhage was higher.
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Effects of tranexamic acid on the amount of bleeding following vaginal delivery and its adverse effects: a double-blind placebo controlled randomized clinical trial
Kashanian M, Dadkhah F, Tabatabaei N, Sheikhansari N
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2021;:1-5
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Editor's Choice
Abstract
INTRODUCTION Postpartum hemorrhage (PPH) is the most important concern after delivery. Tranexamic acid (TXA), an anti-fibrinolytic agent, has been suggested for prevention and treatment of PPH. OBJECTIVE The purpose of the present study was to find the effects of TXA on the amount of bleeding following vaginal delivery and its adverse effects. MATERIALS AND METHODS The study was performed as a randomized double blind placebo controlled clinical trial on low risk pregnant women who delivered vaginally. The patients were randomly assigned into two groups. Women in the intervention group received 10 mg/kg infusion of TXA in 100 mL normal saline and the control group received one vial of distilled water (as placebo) in 100 mL normal saline. The primary outcome was amount of bleeding after delivery. The secondary outcomes were decreased in hemoglobin level, need for additional uterotonic agents and need for blood transfusion. All were evaluated 6 h after delivery and compared in the two groups. Participants were followed up to six weeks after delivery for any TXA side effects. RESULTS Two hundred and seven women finished the study. There were no significant differences between the two groups in terms of demographic data and risk factors for bleeding. Mean blood loss and need to misoprostol was more in the control group (p=.033 and p=.000, respectively). Hemoglobin level was higher in the TXA group 6 h after delivery. None of the subjects needed blood transfusion, uterine balloon tamponade or emergency hysterectomy. Adverse effects were higher in the TXA group, however, there were no side effects between weeks 3 and 6 in both groups. There were no thromboembolic events during six weeks after delivery. CONCLUSIONS Tranexamic acid can reduce the amount of bleeding after vaginal delivery in low risk women without having serious complications. Also, it may decrease the need for additional uterotonic agents. Trial registration number and registry website: IRCT20091023002624N22.
PICO Summary
Population
Low risk pregnant women who delivered vaginally (n= 207).
Intervention
Tranexamic acid (TXA), (n= 104).
Comparison
Placebo (n= 103).
Outcome
There were no significant differences between the two groups in terms of demographic data and risk factors for bleeding. Mean blood loss and need for misoprostol was higher in the control group. Haemoglobin level was higher in the TXA group 6 hours after delivery. None of the women needed blood transfusion, uterine balloon tamponade or emergency hysterectomy. Adverse effects were higher in the TXA group, however, there were no side effects between weeks 3 and 6 in both groups. There were no thromboembolic events during six weeks after delivery.
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Prophylactic use of tranexamic acid for decreasing the blood loss in elective cesarean section: A placebo-controlled randomized clinical trial
Naeiji Z, Delshadiyan N, Saleh S, Moridi A, Rahmati N, Fathi M
Journal of gynecology obstetrics and human reproduction. 2020;:101973
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Editor's Choice
Abstract
INTRODUCTION Tranexamic acid is used as a known treatment of post-partum hemorrhage both in natural vaginal deliveries and cesarean sections, but its use in elective cesarean as a prophylactic measure to decrease the blood loss is not so common. OBJECTIVE This clinical trial evaluates the efficacy and safety of tranexamic acid in decreasing the bleeding in women undergoing elective cesarean section. METHOD 200 term singleton pregnant women who were scheduled for elective cesarean section were randomized to 2 groups and received a bolus of 1 gm tranexamic acid if body weight was <90 kg and 1.5 g if body weight was >90 kg diluted in 15 ml of 5% dextrose intravenously, or 5 ml of distilled water in 15 ml of 5% dextrose as placebo (before skin incision). Intra-operative and post-operative blood loss and hemoglobin levels were compared. RESULTS Tranexamic acid decreased the mean blood loss by 25.3 % in our studied women. Mean volume of intra-operative blood loss was 391.1 (±67.4) ml in tranexamic acid group and 523.8 (±153.4) ml in control group which was statistically significant lesser with a 132.7 ml difference. Rate of >1000 ml and >500 ml bleeding and need to blood transfusion were also statistically significant lower in tranexamic acid group., mean hemoglobin level was statistically significant lower in placebo group than tranexamic acid group (11.77 ± 0.50 versus 11.31 ± 0.56) 6 h after cesarean section. No adverse reaction was documented. CONCLUSION Prophylactic use of intravenous tranexamic acid decreases the blood loss safely in women undergoing elective cesarean section.
PICO Summary
Population
Pregnant women scheduled for elective caesarean section (n= 200).
Intervention
Intravenous tranexamic acid diluted in dextrose (n=100).
Comparison
Placebo: intravenous distilled water diluted in dextrose (n= 100).
Outcome
Tranexamic acid decreased the mean blood loss by 25.3 %. Mean volume of intra-operative blood loss was 391.1 (±67.4) ml in tranexamic acid group and 523.8 (±153.4) ml in placebo group which was statistically significant lesser with a 132.7 ml difference. Rate of >1000 ml and >500 ml bleeding and need to blood transfusion were also statistically significant lower in tranexamic acid group., mean hemoglobin level was statistically significant lower in placebo group than tranexamic acid group (11.77 ± 0.50 versus 11.31 ± 0.56) 6 h after cesarean section. No adverse reaction was documented.
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An economic evaluation of tranexamic acid to prevent postpartum hemorrhage in women with vaginal delivery : the randomized controlled TRAAP trial
Durand-Zaleski I, Deneux-Tharaux C, Seco A, Malki M, Frenkiel J, Sentilhes L
BJOG : an international journal of obstetrics and gynaecology. 2020
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Editor's Choice
Abstract
OBJECTIVE To estimate the cost effectiveness of tranexamic acid (TXA) use to prevent postpartum hemorrhage. DESIGN A trial-based economic evaluation. SETTING 15 French university maternity hospitals. POPULATION women enrolled in the TRAAP randomized controlled trial comparing TXA versus placebo in women with vaginal delivery. TRAAP failed to show a reduction in postpartum hemorrhage of at least 500 ml in the intervention arm but evidenced significant lower rates of secondary outcomes related to blood loss METHODS & MAIN OUTCOME MEASURES We estimated direct medical costs from within-trial hospital resources collected prospectively from the study report form. All resources were costed at their value to the hospital. We estimated incremental cost per incremental hemorrhage averted. RESULTS Among the 4,079 women in the TRAAP trial, data necessary to calculate costs were available for 3,836 (94.0%). The average total costs in the TXA and control groups were €2,278 ±388 and €2,288 ±409 per woman respectively (p= 0.79). In women with postpartum hemorrhage of at least 500 ml (trial primary endpoint), costs were €2,359±354 and €2,409±525 (p=0.14); for provider-assessed clinically significant postpartum hemorrhage and postpartum hemorrhage of at least 1000 ml, costs were respectively €2,316±347 versus €2,381±521 (p=0.22) and €2,321±318versus €2,411±590 (p=0.35) in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% % probability of being cost saving and outcome improving. CONCLUSIONS Our findings support the use of TXA as both bleeding events and cost may be reduced 3 out of 4 times.
PICO Summary
Population
Women enrolled in the Tranexamic Acid for Preventing Postpartum Hemorrhage Following a Vaginal Delivery (TRAAP) trial (n= 3836).
Intervention
Tranexamic acid (TXA), (n= 1918).
Comparison
Placebo (n= 1918).
Outcome
The average total costs in the TXA and control groups were €2,278 ±388 and €2,288 ±409 per woman respectively. In women with postpartum hemorrhage of at least 500 ml (trial primary endpoint), costs were €2,359±354 and €2,409±525); for provider-assessed clinically significant postpartum hemorrhage and postpartum hemorrhage of at least 1000 ml, costs were respectively €2,316±347 vs. €2,381±521 and €2,321±318 vs. €2,411±590 in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% % probability of being cost saving and outcome improving.
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Tranexamic acid for treatment of primary postpartum hemorrhage after vaginal delivery: a systematic review and meta-analysis of randomized controlled trials
Della Corte L, Saccone G, Locci M, Carbone L, Raffone A, Giampaolino P, Ciardulli A, Berghella V, Zullo F
The Journal of Maternal-Fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians. 2018;:1-11.
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Editor's Choice
Abstract
BACKGROUND Postpartum hemorrhage (PPH) is responsible for about 25% of maternal deaths worldwide. Antifibrinolytic agents, mainly tranexamic acid, have been demonstrated to reduce blood loss in patients with established PPH Objective: The aim of this meta-analysis of randomized controlled trials (RCTs) was to evaluate the effectiveness of tranexamic acid administration in women with established primary PPH after vaginal delivery. DATA SOURCES The search was conducted using electronic databases from inception of each database through February 2018. Review of articles also included the abstracts of all references retrieved from the search. No restrictions for language or geographic location were applied. STUDY DESIGN Selection criteria included RCTs comparing the use of tranexamic acid in women with established primary PPH after vaginal delivery with control (either placebo or no treatment). Trials in women undergoing cesarean delivery and trials in prevention of PPH were excluded. The primary outcome was the incidence of hysterectomy. The summary measures were reported as summary relative risk (RR) with 95% of confidence interval (CI) using the random effects model of DerSimonian and Laird. TABULATION, INTEGRATION, AND RESULTS Two trials including 14 363 women with established primary PPH after vaginal delivery were analyzed. Women who received tranexamic acid soon after the diagnosis of PPH had a significantly lower incidence of hysterectomy (0.5 versus 0.8%; RR 0.63, 95% CI 0.42-0.94), compared to those who did not. The risk of thrombotic events was not increased in the tranexamic acid group. CONCLUSION In women with established PPH after vaginal delivery, use of tranexamic acid reduces the risk of hysterectomy and does not increase the risk of thrombotic events. We recommend 1 g plus a second dose of 1 g if bleeding continues after 30 min.
PICO Summary
Population
Women with primary postpartum haemorrhage (PPH) after vaginal delivery (2 studies, n= 14,363).
Intervention
Tranexamic acid (TXA), (n= 7,165).
Comparison
Placebo or no treatment (n= 7,198).
Outcome
Women who received TXA soon after the diagnosis of PPH had a significantly lower incidence of hysterectomy (0.5% vs 0.8%; RR 0.63, 95% CI 0.42-0.94), compared to those who did not. The risk of thrombotic events was not increased in the TXA group.