Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery

Background:To assess the efficacy and safety of tranexamic acid (TA) in reducing blood loss and lowering transfusion needs for patients undergoing caesarean section (CS) or vaginal delivery (VD).Methods:An electronic literature search of PubMed, EMBASE, OVID, Cochrane library, Scopus, Central, and Clinical trials.gov was performed to identify studies that evaluating the usage of TA in CS or VD. The methodological quality of included trials was assessed and data extraction was performed.Results:Finally, 25 articles with 4747 participants were included. Our findings indicated TA resulted in a reduced intra-, postoperative, and total blood loss by a mean volume of 141.25 mL (95% confidence interval [CI] −186.72 to −95.79, P < 0.00001), 36.42 mL (95% CI −46.50 to −26.34, P < 0.00001), and 154.25 mL (95% CI −182.04 to −126.47, P < 0.00001) in CS. TA administration in VD was associated with a reduced intra-, postoperative, and total blood loss by a mean volume of 22.88 mL (95% CI −50.54 to 4.77, P = 0.10), 41.24 mL (95% CI −55.50 to −26.98, P < 0.00001), and 84.79 mL (95% CI −109.93 to −59.65, P < 0.00001). In addition, TA could lower the occurrence rate of postpartum hemorrhage (PPH) and severe PPH, and reduce the risk of blood transfusions. No increased risk of deep vein thrombosis (DVT) after CS or VD was associated with TA usage, while the minor side effects were more common.Conclusions:Our findings indicated that intravenous TA for patients undergoing CS was effective and safe. Although prophylactic TA administration is associated with reduced PPH, current existing data are insufficient to draw definitive recommendations about its clinical significance due to the poor to moderate quality of the included literatures. Thus, high-quality randomized controlled trials with larger samples are needed to validate our findings.

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“…The outcome measure of severe PPH was available in 4 trials [14,17,29,30] in CS and 2 trials [33,34] for VD (Fig. 4B).…”

Section: Resultsmentioning

confidence: 99%

“…The outcome measure of transfusion needs was available in 8 trials [14,18,19,22,24,28,30,31] in CS and 1 trial [33] in VD (Fig. 4C).…”

Section: Resultsmentioning

confidence: 99%

Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention?

Gong

Dong

et al. 2017

Medicine

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“…Seven trial registrations without sufficient data for analysis were also excluded. Finally, 21 studies (19 research papers and 2 conference abstracts) with 3852 patients were eligible for our analysis. Figure shows the details of study selection and inclusion.…”

Section: Resultsmentioning

confidence: 99%

“…Two studies had an unclear bias due to incomplete outcome data. The study by Sujata et al . was described with unclear risk of other bias, because a patient in control group with postoperative hemoglobin level of 69 g/L refused the blood transfusion and a patient in control group received TXA on the first postoperative day due to continuous bleeding.…”

Section: Resultsmentioning

confidence: 99%

“…However, there is still a controversy about the prophylactic application of TXA to patients undergoing CS. Thus, we identified all available randomized controlled trials (RCT), totally 21, to evaluate whether preoperative administration of TXA has potential effects on reducing blood loss as well as transfusion requirements for patients undergoing CS. Moreover, we also investigated the impact of TXA on other factors associated with bleeding, including hemoglobin and hematocrit drops, additional uterotonic agent use (oxytocin and methylergometrine) and massive hemorrhage rate.…”

Section: Introductionmentioning

confidence: 99%

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Prophylactic use of tranexamic acid reduces blood loss and transfusion requirements in patients undergoing cesarean section: A meta‐analysis

Wang

Liu

2019

J of Obstet and Gynaecol

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Aim: Tranexamic acid (TXA) has been used to treat peripartum hemorrhage, while preoperative use of TXA in cesarean section (CS) remains controversial. To assess the effectiveness and safety of prophylactic application of TXA, a meta-analysis was performed. Methods: Electronic databases (MEDLINE [PubMed], Cochrane central register of controlled trials and Embase) were searched up to November 2018. The relevant data and quality of included trail were analyzed by RevMan 5.3. The study was registered at PROSPERO (CRD42018111165).Results: Twenty-one randomized controlled trials with a total of 3852 patients were included. Only one research reported thromboembolic events. Compared with control groups, the intra-operative blood loss (mean difference [MD] −155.23 mL, 95% confidence interval [CI] −195.64 − 114.81; P<0.01), postoperative blood loss (MD −26.67 mL, 95% CI −32.98 to −20.36; P<0.01), total blood loss (MD −184.88 mL, 95% CI −218.83 to −150.94; P<0.01), transfusion requirements (relative risk [RR] 0.29, 95% CI 0.18−0.49, P<0.01), massive hemorrhage (RR 0.39, 95% CI 0.30 to 0.51; P<0.01) and additional uterotonic agents use (RR 0.40, 95% CI 0.30−0.55, P<0.01) were markedly reduced in TXA-treated patients. Besides, TXA yielded a significant reduction in hemoglobin drop (MD −0.80 g/dL, 95% CI −1.07 to −0.53; P<0.01) and hematocrit drop (MD −2.05, 95% CI −3.09 to −1.01; P<0.01) compared with control groups. Conclusion: Prophylactic application of TXA can decrease perioperative blood loss and transfusion requirements in patients undergoing CS. More high-quality researches are needed to determine optimal dose of the drug.

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Evaluation and Treatment of Postpartum Hemorrhage

Bromberek

Smereck

2017

Emergency Department Management of Obstetric Complications

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Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery

Abstract: Intravenous tranexamic acid, administered before skin incision, significantly reduced the requirement for additional uterotonics among women at increased risk for postpartum hemorrhage. Clinical Trials Registry India: CTRI/2015/05/005752.

Cited by 29 publications

References 17 publications

Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention?

Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention?

Prophylactic use of tranexamic acid reduces blood loss and transfusion requirements in patients undergoing cesarean section: A meta‐analysis

Evaluation and Treatment of Postpartum Hemorrhage

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