Does prophylactic tranexamic acid reduce blood loss in Indian women following vaginal delivery?
DOI:
https://doi.org/10.18203/2320-1770.ijrcog20200057Keywords:
Postpartum hemorrhage, Anemia, Uterotonics, Tranexamic acidAbstract
Background: Postpartum hemorrhage (PPH) accounts for 25% to 33% of obstetric deaths every year. Anemia is a cause and consequence of PPH. Despite intense efforts to prevent anemia, many Indian women labour with low hemoglobin levels. Tranexamic acid (TXA), an antifibrinolytic, have been demonstrated to reduce blood loss and transfusion requirements in various surgeries including cesarean section. Objectives were to study the efficacy of TXA in effectively reducing blood loss in Indian women following vaginal delivery.
Methods: This randomized, double-blind, placebo-controlled study was conducted on 200 patients scheduled for vaginal delivery. In addition to oxytocin 10 units, group T received TXA 15 mg/kg and group P received normal saline administered over 5 minutes. Estimated blood loss, Hemoglobin deficit, need for additional uterotonics, need for blood transfusion, incidence of PPH and adverse events were noted.
Results: The fall in hemoglobin was significantly higher in group P (p<0.00001). Estimated 24 hour blood loss was significantly higher by a mean blood volume of 86.99 ml in group P compared to group T (p<0.00001). The incidence of PPH was lower in group T (2.8% versus 11.3%). There were no significant difference in the need for supplementary uterotonics (9.9% versus 15.5%) and the incidence of blood transfusion (2.8% versus 8.5%). No adverse maternal and fetal outcomes were noted.
Conclusions: To reduce blood loss following vaginal delivery, TXA may be safely recommended as standard adjunct to Oxytocin for regular management of third stage of labour, especially in developing countries like India.
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References
Say L, Chou D, Gemmill A, Tunçalp O, Moller AB, Daniels J et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014;2(6):323-33.
Nair M, Choudhry MK, Choudhry SS, Kakoty SD, Sarma UC, Webster P, et al. on behalf of the IndOSS-Assam Steering Committee. Association between maternal anaemia and pregnancy outcomes: a cohort study in Assam, India. BMJ Global Health. 2016;1:000026.
National Family Health Survey (NFHS-III), 2005-2006. Available at: http://www.nfhsindia.org/pdf/India.pdf. Accessed on: 04 February 2014.
Ekeroma AJ, Ansari A, Stirrat GM. Blood transfusion in obstetrics and gynaecology. Br J Obstet Gynaecol. 1997;104(3):278-84.
Thompson JF, Heal LJ, Roberts CL, Ellwood DA. Women’s breastfeeding experiences following a significant primary postpartum haemorrhage: a multicentre cohort study. Int Breastfeed J. 2010;5:5.
American College of Obstetricians and Gynecologists. Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006;108:1039-47.
Deneux-Tharaux C, Sentilhes L, Maillard F, Closset E, Vardon D, Lepercq J, et al. Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR). BMJ. 2013;346:1541.
Sentilhes L, Merlot B, Madar H, Sztark F, Brun S, Deneux-Tharaux C. Postpartum haemorrhage: prevention and treatment. Expert Rev Hematol. 2016;9:1043-61.
Yang H, Zheng S, Shi C. Clinical study on the efficiency of tranexamic acid in reducing postpartum blood loss—a randomized multicentre trial. Zhonghua Fu Chan Zazhi. 2001;36(10):590-2.
Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003;29:125-30.
Peitsidis P, Kadir RA. Tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011;12(4):503-16.
Cortet M, Deneux-Tharaux C, Dupont C, Colin C, Rudigoz RC, Bouvier-Colle MH, et al. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth. 2012;108:984-9.
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 Lond Engl. 2011;15:117.
Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010;(7):CD007872.
Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012;344:3054.
Myles PS, Smith JA, Forbes A, et al. Tranexamic acid in patients undergoing coronary-artery surgery. N Engl J Med. 2017;376:136-48.
CRASH-2 trial collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, et al. 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. 2010;376:23-32.
Matteson KA, Rahn DD, Wheeler 2nd TL, Casiano E, Siddiqui NY, Harvie HS, et al. Nonsurgical management of heavy menstrual bleeding: a systematic review. Obstet Gynecol. 2013;121:632-43.
Li C, Gong Y, Dong L. Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention? A systematic review and meta-analysis. Medicine. 2017;96:5653.
Gungorduk K, Asicioglu O, Yildirim G. Can intravenous injection of tranexamic acid be used in routine practice with active management of the third stage of labor in vaginal delivery? A randomized controlled study. Am J Perinatol. 2013;30:407-13.
Sentilhes L, Winer N, Azria E. Tranexamic acid for the prevention of blood loss after vaginal delivery. N Engl J Med. 2018;379:731-42.
Ferrer P, Roberts I, Sydenham E. Anti-fibrinolytic agents in post partum haemorrhage: a systematic review. BMC Pregnancy Childbirth. 2009;9:29.
WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebocontrolled trial. Lancet. 2017;389:2105-16.
Galambosi PJ, Gissler M, Kaaja RJ, Ulander VM. Incidence and risk factors of venous thromboembolism during postpartum period: a population-based cohort-study. Acta Obstet Gynecol Scand. 2017;96:852-61.
Gilad O, Merlob P, Stahl B, Klinger G. Outcome following tranexamic acid exposure during breastfeeding. Breastfeed Med. 2014;9:407-10.
Summary of Product Characteristics for Cyklokapron. Available at: http://www. medicines.org.uk/ emc/medicine/16512/SPC/Cyklokapron+Tablets/. Accessed on: 31 March 2017.
Saccone G, Corte L D, D’Alessandro P, Ardino B, Carbone L, Raffone A. Prophylactic use of tranexamic acid after vaginal delivery reduces the risk of primary postpartum hemorrhage. J Matern Fetal Neonatal Med. 2020;33(19):3368-76.
Kozek-Langenecker SA, Afshari A, Albaladejo P, Santullano CA, De Robertis E, et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2013;30:270-382.
World Health Organization (WHO). Updated WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Haemorrhage. Geneva, Switzerland: WHO. 2017. Available at: https://www.who.int/reproductivehealth/publications/tranexamic-acid-pph-treatment/en/. Accessed on: 27 September 2020.
Toteja G, Singh P. Report of an ICMR Task Force Study-District Nutrition Project. 2001;1.
Shakur-Still H, Roberts I, Fawole B, Kuti M, Olayemi OO, Bello A. Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial. Welcome Open Res. 2018;3(100).
Ismail AM, Abbas AM, Shahat MA, Ali MK. Evaluation of Subendometrial and Intramyometrial Blood Flow after Intravenous Tranexamic Acid for Prevention of Postpartum Hemorrhage in Vaginal Delivery: A Randomized Controlled Study. J Gynecol Res Obstet. 2017;3(2):46-50.
Ker K, Prieto-Merino D, Roberts I. Systematic review, meta-analysis and meta-regression of the effect of tranexamic acid on surgical blood loss. Br J Surg. 2013;100:1271-9.
Sentilhes L, Daniel V, Darsonval A, Deruelle P, Vardon D, Perrotin F, et al. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial. BMC Pregnancy Childbirth. 2015;15:135.
Goswami U, Sarangi S, Gupta S. 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. Saudi J Anaesth. 2013;7:427.
Lundin ES, Johansson T, Zachrisson H, Leandersson U, Backman F, Falknas L, et al. Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study. Acta Obstet Gynecol Scand. 2014;93(4):335-44.
Gayet-Ageron A, Prieto-Merino D, Ker K, Shakur H, Ageron FX, Roberts I. Effect of treatment delay on the effectiveness and safety of antifibrinolytics in acute severe haemorrhage: a meta-analysis of individual patient-level data from 40138 bleeding patients. Lancet. 2017;391:125-32.
Roy P, Sujatha MS, Bhandiwad A, Biswas B. Role of Tranexamic Acid in Reducing Blood Loss in Vaginal Delivery. J Obstet Gynecol India. 2016;66(1):246-50.
Esmail El-Garhy, Mohamed A H, Elshahat A, et al. Tranexamic acid for prevention of postpartum hemorrhage after vaginal delivery. Egypt J Hospital Med. 2018;73(2):6157-64.
Mirghafourvand M, Alizadeh SM, Abasalizadeh F, Shirdel M, et al. The effect of intravenous tranexamic acid on hemoglobin and hematocrit levels after vaginal delivery: a randomized controlled trial. Iranian J Obstet Gynecol Infertil. 2013;16:1-8.
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