Novikova N8484 Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015:CD007872.
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Healthy women with low risk of bleeding by caesarean section or childbirth |
Evaluates 12 RCT. |
N: 3285 |
To determine the effectiveness and safety of TXA in preventing PPH compared to placebo, no treatment, or uterotonics |
Decrease incidence of bleeding greater than 400-500 mL in vaginal delivery. |
Nausea and vomiting were more frequent in TXA group. |
Using the GRADE criteria, the risk of bias was assessed as moderate |
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(2015) |
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9: Efficacy of pre incisional TXA in caesarean sections |
Caesarea’s: 2453 |
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Decrease bleeding more than 1000 mL in caesarean sections. |
Serious adverse effects could not be assessed by sample size |
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Meta-analysis and Systematic review |
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3: Efficacy of TXA after vaginal delivery. |
Deliveries: 832 |
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Decrease bleeding, blood transfusion, and additional medical interventions. |
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In all RCTs, TXA was associated with uterotonics and compared with placebo or no treatment. |
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Mirghafourvand M8686 Mirghafourvand M, Mohammad-Alizadeh S, Abbasalizadeh F, et al. The effect of prophylactic intravenous tranexamic acid on blood loss after vaginal delivery in women at low risk of postpartum haemorrhage: a double-blind randomised controlled trial. Aust N Z J Obstet Gynaecol. 2015;55:53-8.
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Pregnant women with a single foetus at low risk of PPH |
TXA group: 1 g of after delivery |
N: 120 |
To assess the effect of TXA on postpartum vaginal bleeding in low risk of postpartum haemorrhage women |
Bleeding as measured was significantly less in the TXA group. |
2 cases had nausea and vomiting in TXA group and none in the control group, but the study is not powerful to assess adverse effects. |
The size of the study is one of its biggest biases. |
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(2015) |
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Control: Placebo |
TXA: 60 |
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No thrombotic events. |
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RCT double-blind |
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Control: 60 |
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Sujata N8787 Sujata N, Tobin R, Kaur R, et al. Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery. Int J Gynaecol Obstet. 2016;133:312-5.
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Women undergoing elective or urgent caesarean section with high risk of PPH |
TXA group: 10 mg.kg-1
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N: 60 |
To assess the effect of TXA in patients undergoing caesarean section with a high risk of PPH |
TXA group required significantly less additional uterotonics. |
TXA was safe for both and was not associated with a greater number of thrombogenic events, but the power of the study was insufficient to analyse the adverse effects. |
The risk of bias is high because the study was not double-blind. |
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(2016) |
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Control: Saline Serum |
TXA: 30 |
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RCT |
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Both administered 10 minutes before the incision. |
Control: 30 |
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WOMAN55 Shakur H, Roberts I, Fawole B, et al. 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;389:2105-16.
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Women > 16 years old with clinical diagnosis of PPH after caesarean section or vaginal delivery |
TXA group: 1 g, and a possible second dose after 30 minutes if bleeding was ongoing. |
N: 20.021 |
To determine the effects of TXA on mortality, hysterectomy, and other complications in women with PPH |
TXA did not decrease mortality from any cause or the incidence of hysterectomy. |
There were no significant differences regarding the incidence of thromboembolic events, organ failure, or sepsis. |
Regarding hysterectomy, in many cases the decision to perform a hysterectomy was already made before administering the drug. |
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(2017) |
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Control: Placebo. |
TXA: 10,036 |
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TXA decreased mortality from bleeding in patients who were administered in the first 3 hours postpartum. |
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Regarding mortality, in some cases it was so early after randomization that it should not be associated with AT use. |
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RCT multicentre, double blind |
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Control: 9,985 |
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The TXA also significantly reduced the incidence of laparotomies to control bleeding. |
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Brenner A (Brenner et al., 2018) |
WOMAN’s study patients randomized in the first 3 hours postpartum. |
TXA group: 1 g and a possible second dose after 30 minutes if bleeding was ongoing. |
N: 14,923 |
To determine the effects of TXA on mortality and hysterectomy in women with PPH |
TXA showed a significant decrease in death from bleeding, but not from hysterectomy. |
No evaluated |
This sub-analysis tries to avoid the biases discussed in the WOMAN study, but it has important statistical limitations. |
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WOMAN sub- analysis |
Excluding hysterectomies and early deaths |
Control: Placebo. |
TXA: 7,518 |
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Control: 7,405 |
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Sentilhes L8888 Sentilhes L, Winer N, Azria E, et al. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018;379:731-42.
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Women in labour with vaginal delivery of a single expected child without increased risk of bleeding or thrombosis |
TXA group: 1 g of TXA after delivery |
N: 3,891 |
To know if the administration of prophylactically TXA in addition to oxytocin after delivery reduces the incidence of PPH |
TXA decreased bleeding ≥ 500 mL, but not significantly (p= 0,07) |
TXA was associated with an increased incidence of nausea and vomiting, but not increase the incidence of thromboembolic events at 3 months. |
The importance of the difference between ≥ 500 mL and > 500 mL remains to be defined. |
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(2018) |
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Control: Placebo |
TXA: 1,945 |
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TXA decreased significantly bleeding > 500 mL, clinically significant PPH, and the use of additional uterotonics. |
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RCT multicentre, double blind |
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Control: 1,946 |
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