Abstract
Purpose
To assess the efficacy and safety of an intravenous formulation of tranexamic acid to reduce intrapartum and postpartum bleeding in patients giving birth by cesarean section.
Methods
Healthy women with normal pregnancies, at any gestational age, that we performed ceaserean section. Two hundred and twenty-three patients with cesarean section, were enrolled in a double-blind, placebo-controlled study. Tranexamic acid of 20 cc and a 20 cc 5 % dextrose solution was intravenously injected to the patients; both the study group (n = 101) and the control group (n = 122) 10 min before the start of cesarean section. We measured volume of blood loss in postoperative periods, decrease in hemoglobin and hematocrit levels after cesarean section. The mean follow up was 2 weeks after the operation.
Results
Tranexamic acid reduced intraoperative and postoperative blood loss. We did not observe any complications caused by TA such as venous thromboembolism, gastrointestinal problems and hypersensitivity.
Conclusions
This study confirms that tranexamic acid is effective in reducing intrapartum and postpartum bleeding in patients giving birth by cesarean section. Although some obstetricians are still worried about its thrombosis risk, our study shows that it can be used safely in aforementioned patients.
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References
Gungorduk K, Yıldırım G (2011) Efficacy of Intravenous Tranexamic acid in reducing blood loss after elective caesarean section: a prospective, randomized, double-blindplacebo-Controlled Study. Am J Perinatol 28(3):233–240
Magann EF, Evans S, Hutchinson M, Collins R, Lanneau G, Morrison JC (2005) Postpartum hemorrhage after caesarean delivery: an analysis of risk factors. South Med J 98(7):681–685
Hogan MC, Foreman KJ, Naghavi M, Ahn SY, Wang M, Makela SM, Lopez AD, Lozano R, Murray CJ (2010) Maternal mortality for 181 countries, 1980–2008: a systematic analysis of progress towards millennium development goal 5. Lancet 375(9726):1609–1623
Ronsmans C, Graham WJ (2006) Maternal mortality: who, when, where, and why. Lancet 368(9542):1189–1200
AbouZahr C (2003) Global burden of maternal death and disability. Br Med Bull 67:1–11
Munn MB, Owen J, Vincent R, Wakefield M, Chestnut DH, Hauth JC (2001) Comparison of two oxytocin regimens to prevent uterine atony at caesarean delivery: a randomized controlled trial. Obstet Gynecol 98(3):386–390
Sekhavat L, Tabatabaii A, Dalili M, Farajkhoda T, Tafti AD (2009) Efficacy of tranexamic acid in reducing blood loss after caesarean section. J Matern Fetal Neonatal Med 22(1):72–75
Shakur H, Elbourne D, Gülmezoglu M, Alfirevic Z, Ronsmans C, Allen E, Roberts I (2010) The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. Trials 16(11):40
Peitsidis P, Kadir RA (2011) Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother 12(4):503–516
Gleeson NC, Buggy F, Sheppard BL, Bonnar J (1994) The effect of tranexamic acid on measured menstrual loss and endometrial fibrinolytic enzymes in dysfunctional uterine bleeding. Acta Obstet Gynecol Scand 73(3):274–277
Rath W, Hackethal A, Bohlmann MK (2012) Second-line treatment of postpartum haemorrhage. Arch Gynecol Obstet 286(3):549–561
Gai MY, Wu LF, Su QF, Tatsumoto K (2004) Clinical observation of blood loss reduced by tranexamic acid during and after caesarian section: a multi-center, randomized trial. Eur J Obstet Gynecol Reprod Biol 112(2):154–157
Cook L, Roberts I, WOMAN Trial Collaborators (2010) Post-partum haemorrhage and the WOMAN trial. Int J Epidemiol 39(4):949–950
Stafford I, Dildy GA, Clark SL, Belfort MA (2008) Visually estimated and calculated blood loss in vaginal and caesarean delivery. Am J Obstet Gynecol 199(5):519
Gohel M, Patel P, Gupta A, Desai P (2007) Efficacy of tranexamic acid in decreasing blood loss during and after caesarean section: a randomized case controlled prospective study. J Obstet Gynecol India 57:227–230
Gherman RB, Goodwin TM, Leung B, Byrne JD, Montoro M (1998) Incidence, clinical characteristics, and timing of objectively diagnosed venous thromboembolism during pregnancy. Prim Care Update Ob Gyns 5(4):155–156
Toglia MR, Weg JG (1996) Venous thromboembolism during pregnancy. N Engl J Med 335(2):108–114
Shakur H, Roberts I et al (2010) 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 376(9734):23–32
Caglar GS, Tasci Y, Kayikcioglu F, Haberal A (2008) Intravenous tranexamic acid use in myomectomy: a prospective randomized double-blind placebo controlled study. Eur J Obstet Gynecol Reprod Biol 137(2):227–231
Sundström A, Seaman H, Kieler H, Alfredsson L (2009) The risk of venous thromboembolism associated with the use of tranexamic acid and other drugs used to treat menorrhagia: a case-control study using the General Practice Research Database. BJOG 116(1):91–97
Taparia M, Cordingley FT, Leahy MF (2002) Pulmonary embolism associated with tranexamic acid in severe acquired haemophilia. Eur J Haematol 68(5):307–309
Imbesi S, Nettis E, Minciullo PL, Di Leo E, Saija A, Vacca A, Gangemi S (2010) Hypersensitivity to tranexamic acid: a wide spectrum of adverse reactions. Pharm World Sci 32(4):416–419
Schulz KF, Altman DG, Moher D (2010) CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials BMJ 340:332
Molenaar IQ, Warnaar N, Groen H, Tenvergert EM, Slooff MJ, Porte RJ (2007) Efficacy and safety of antifibrinolytic drugs in liver transplantation: a systematic review and meta-analysis. Am J Transplant 7(1):185–194
Acknowledgments
The study method was approved by the ethics committee and a written approval from every patient involved in the study was received in advance. Ministry of Health paid the cost of drugs.
Conflict of interest
None of the authors have conflict of interest.
Ethical Standard
The procedures of the study received ethics approval from the institutional ethics committee that is responsible for human experimentation.
Funding
Ministry of Health paid the cost of drugs. I want to say special thanks to the nurses of operation room, anesthesia technicians and anesthesiologist Dr. Taşkın BUDAKÇI and worker of Batman Women Health And Children’s Hospital.
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Sentürk, M.B., Cakmak, Y., Yildiz, G. et al. Tranexamic acid for cesarean section: a double-blind, placebo-controlled, randomized clinical trial. Arch Gynecol Obstet 287, 641–645 (2013). https://doi.org/10.1007/s00404-012-2624-8
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DOI: https://doi.org/10.1007/s00404-012-2624-8