Comparative evaluation of two doses of tranexamic acid used prophylactically in anemic parturients for lower segment cesarean section: A double-blind randomized case control prospective trial

Upasana Goswami, Sushmita Sarangi, Sunali Gupta, Savita Babbar, Upasana Goswami, Sushmita Sarangi, Sunali Gupta, Savita Babbar

Abstract

Background: Postpartum hemorrhage (PPH) and anemia thereafter can be a life threatening condition in parturients undergoing lower segment cesarean section (LSCS), especially when anemia is present.

Aim: The objective of this study was to assess two doses of Tranexamic acid (TXA) in reducing intra operative blood loss and incidence of PPH, in terms of both efficacy and safety profiles, when used prophylactically.

Methods: A monocenter prospective case control double blind randomized study was carried out on a consecutive series of 90 anemic patients undergoing LSCS, with hemoglobin between 7-10 g percent. Three random groups were formed. Group T1 (n=30) received 10mg/kg TXA in 20 ml of 5% dextrose intravenously, while T2 group (n=30) received 15mg/kg. Group C (n=30) received a placebo. Drug was administered prophylactically 20 min before skin incision. Blood loss was measured from placental delivery up to 24 hours by method of weight and volume.

Staistical analysis: To compare quantitative data between two groups, t-test, and for more than two groups ANOVA was used. To compare the mean for non- parametric data between two groups Mann - Whitney test was used, while in case of more than two groups Kruskal - Wallis test was employed. Probability (p) value was considered significant when it was 0.05 or less.

Results: TXA significantly reduced blood loss in both the study groups. Mean total blood loss was 527.17±88.666 ml, 376.83±31.961ml and 261.17±56.777 ml in group C, T1, and T2 respectively. While reduction of blood loss in T1 group compared to control group was 146.34±56.32ml, it was 262±31.51ml in T2 group. Difference between T1 and T2 was 115.66±24.81ml, which was statistically significant (P<0.05). Postoperative blood loss was insignificant in all three groups. Pre- and post-operative hemoglobin levels differed significantly when compared to control group. Blood transfusion was needed in two patients in the control group, whereas no patient in groups T1 and T2 needed transfusion (P=0.02). No significant adverse effect was seen in all the three groups.

Conclusion: Hence, TXA was found to be effective in reducing blood loss and transfusion in anemic parturients undergoing LSCS. 15mg/kg dose of TXA was more efficacious than the 10mg/kg dose and without any undue increase in adverse events. Postpartum anemia is a public health problem worldwide and TXA could prove to be a very useful drug to prevent blood loss and transfusions in patients undergoing LSCS, especially in the anemic subgroup.

Keywords: Anemia; blood sparing; lower segment cesarean section; postpartum haemorrhage; tranexamic acid.

Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
% Change in Hemoglobin from pre- to post-operative period. Gr-C – Group C, Gr-T1 – Group T1, Gr-T2 – Group T2

References

    1. Kambo I, Bedi N, Dhillon BS, Saxena NC. A critical appraisal of cesarean section rates at teaching hospitals in India. Int J Gynaecol Obstet. 2002;79:151–8.
    1. Abou Zahr C. 1st ed. Ch 4. Vol. 4. Boston (United States of America), Geneva, (Switzerland): Harvard School of Public Health on behalf of the World Health Organization and the World Bank; 1998. Antepartum and Postpartum Hemorrhage.
    1. Gohel M, Patel P, Gupta A, Desai P. Efficacy of tranexamic acid in decreasing blood loss during and after caesarean section: A randomized case controlled prospective study. Obstet Gynaecol India. 2007;57(3):227–30.
    1. Kodkany BS, Derman RJ, Goudar SS, Geller SE, Edlavitch SA, Naik VA, et al. Initiating a novel therapy in preventing postpartum hemorrhage in rural India: A joint collaboration between the United States and India. Int J Fertil Womens Med. 2004;49:91–6.
    1. Kalaivani K. Prevalence and consequences of anaemia in pregnancy. Available from: .
    1. Ekeroma AJ, Ansari A, Stirrat GM. Blood transfusion in obstetrics and gynaecology. Br J Obstet Gynaecol. 1997;104:278–84.
    1. Healy TEJ, Knight PR. 7th edition. Churchill-Davidson; 2003. Obstetric Anaesthesia. Wylie and Churchill-Davidson's A Practice of Anaesthesia; p. 934.
    1. Gai MY, Wu LF, Su QF, Tatsumoto K. A clinical observation of blood loss reduced by tranexamic acid during and after caesarean section: A multi-central trial, randomized trial. Eur J Obstet Gynecol Reprod Biol. 2004;112:154–7.
    1. Charbit B, Mandelbrot L, Samain E, Baron G, Haddaoui B, Keita H, et al. The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost. 2007;5:266–73.
    1. Lynn M, Jeroukhimov I, Klein Y, Martinowitz U. Updates in the management of severe coagulopathy in trauma patients. Intensive Care Med. 2002;28:S241–7.
    1. Thorsen S, Clemmensen I, Sottrup-Jensen L, Magnusson S. Adsorption to fibrin of native fragments of known primary structure from human plasminogen. Biochim Biophys Acta. 1981;668:377–87.
    1. Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, et al. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15:R117.
    1. Sekhavat L, Tabatabaii A, Dalili M, Farajkhoda T, Tafti AD. Efficacy of tranexamic acid in reducing blood loss after cesarean section. J Matern Fetal Neonatal Med. 2009;22:72–5.
    1. Gungorduk K, Yıldırım G, Asıcıoğlu O, Gungorduk OC, Sudolmus S, Ark C. Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: A prospective, randomized, double-blind, placebo-controlled study. Am J Perinatol. 2011;28:233–40.
    1. Movafegh A, Eslamian L, Dorabadi A. Effect of intravenous tranexamic acid administration on blood loss during and after cesarean delivery. Int J Gynaecol Obstet. 2011;115:224–6.
    1. Hiippala ST, Strid LJ, Wennerstrand MI, Arvela JV, Niemelä HM, Mäntylä SK, et al. Tranexamic acid radically decreases blood loss and transfusions associated with total knee arthroplasty. Anesth Analg. 1997;84:839–44.
    1. Karski JM, Teasdale SJ, Norman P, Carroll J, VanKessel K, Wong P, et al. Prevention of bleeding after cardiopulmonary bypass with high-dose tranexamic acid. Double-blind, randomized clinical trial. J Thorac Cardiovasc Surg. 1995;110:835–42.
    1. Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010;7:CD007872.
    1. Horrow JC, Van Riper DF, Strong MD, Grunewald KE, Parmet JL. The dose-response relationship of tranexamic acid. Anesthesiology. 1995;82:383–92.
    1. Peitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011;12:503–16.

Source: PubMed

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