Efficacy of Tranexamic Acid in Reducing Blood Loss Following Vaginal Delivery: A Double-Blind Randomized Controlled Trial

Main Article Content

Dr. Kusum Saini
Dr. Pushpa Nagar
Dr. Neha

Abstract

Background: Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide. This study aimed to evaluate the efficacy of tranexamic acid (TXA) in reducing blood loss following vaginal delivery in an Indian setting.


Method: A double-blind, randomized controlled trial was conducted at SMS Medical College, Jaipur, from April 2023 to October 2023. A total of 130 women undergoing vaginal delivery were randomly assigned to receive either 1g of TXA (Group A) or placebo (Group B) intravenously within 2 minutes of delivery. Blood loss was measured using graduated drapes and weighed swabs. Secondary outcomes included estimation of change in hemoglobin and hematocrit levels, need for additional uterotonics, and blood transfusions. Statistical analysis was performed using IBM SPSS version 23.0.0.


Results: The TXA group demonstrated a significant reduction in mean blood loss (347.23 ± 96.92 ml) compared to the placebo group (399.07 ± 98.08 ml, p = 0.003). Hemoglobin and hematocrit levels were significantly higher in the TXA group post-delivery (hemoglobin: 9.97 ± 0.80 gm%, p < 0.001; hematocrit: 37.47 ± 1.55%, p = 0.001). Additionally, fewer patients in the TXA group required additional uterotonics (7.6% vs. 21.53%, p = 0.025) and blood transfusions (3.07% vs. 12.30%, p = 0.048). Hospital stay was shorter for the TXA group (p = 0.048).


Conclusion: Prophylactic administration of TXA significantly reduces blood loss following vaginal delivery, decreases the need for additional uterotonics, and shortens hospital stay. These findings suggest that TXA can be a valuable tool in the prevention of PPH, particularly in resource-limited settings.

Article Details

How to Cite
Dr. Kusum Saini, Dr. Pushpa Nagar, & Dr. Neha. (2024). Efficacy of Tranexamic Acid in Reducing Blood Loss Following Vaginal Delivery: A Double-Blind Randomized Controlled Trial. International Journal of Medical Science and Clinical Research Studies, 4(9), 1675–1685. https://doi.org/10.47191/ijmscrs/v4-i09-15
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References

I. Khan KS, Wojdyla D, Say L, Gülmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):106674.

II. Say L, Chou D, Gemmill A, Tunçalp Ö, Moller AB, Daniels J, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6).

III. WHO Postpartum Haemorrhage Summit. Postpartum haemorrhage (PPH): a global public health concern. March 7-10, 2023.

IV. Calvert C, Thomas SL, Ronsmans C, Wagner KS, Adler AJ, Filippi V. Identifying regional variation in the prevalence of postpartum haemorrhage: a systematic review and meta-analysis. PLoS One. 2012 Jul 23;7(7).

V. Ministry of Health and Family Welfare. WHO: A roadmap to combat postpartum haemorrhage between 2023 and 2030. 2022 Nov 30.

VI. Dutta DC. Textbook of Obstetrics. 7th ed. New Delhi: Jaypee Brothers Medical Publishers; 2013. p. 410.

VII. Royal College of Obstetricians and Gynaecologists. Prevention and Management of Postpartum Haemorrhage Green-top Guideline No. 52. 2016 Dec 16.

VIII. Mousa HA, Blum J, Abou El Senoun G, Shakur H, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database Syst Rev. 2014;(2).

IX. Alexander J, Thomas P, Sanghera J. Treatments for secondary postpartum haemorrhage. Cochrane Database Syst Rev. 2002;(1).

X. Thornburg KL, Jacobson SL, Giraud GD, Morton MJ. Hemodynamic changes in pregnancy. Semin Perinatol. 2000 Feb;24(1):11-4.

XI. Escobar MF, Hidalgo AM, Fonseca C, et al. FIGO recommendations on the management of postpartum haemorrhage. Int J Gynaecol Obstet. 2022 Sep;159(Suppl 1):1-48.

XII. Anderson JM, Etches D. Prevention and management of postpartum haemorrhage. Am Fam Physician. 2007 Mar 15;75(6):875-82.

XIII. Oyelese Y, Ananth CV. Postpartum haemorrhage: epidemiology, risk factors, and causes. Clin Obstet Gynecol. 2010 Mar;53(1):147-56.

XIV. ACOG Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum haemorrhage. Obstet Gynecol. 2006;108(4):1039-47.

XV. Westhoff G, Cotter AM, Tolosa JE. Prophylactic oxytocin for the third stage of labor to prevent postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Oct 1;(10).

XVI. Andersen HF, Hopkins MP. Postpartum Haemorrhage. Glob Libr Women’s Med [Internet]. 2008 [cited 2024 Jul 15]; Available from: https://www.glowm.com/sectionview/heading/Postpartum%20Haemorrhage/item/10138.

XVII. Fissahaye B, Dheresa M, Assefa N, et al. Active management of the third stage of labor and associated factors among maternity care providers in public health facilities in Eastern Ethiopia: a multi-center study. BMC Pregnancy Childbirth. 2023 Sep 28;23(1):701.

XVIII. Marshall JE, Raynor MD. Myles Textbook for Midwives. 15th ed. Edinburgh: Churchill Livingstone Elsevier; 2014.

XIX. Elbourne D, Prendiville W, Carroli G, Wood J, McDonald S. Prophylactic use of oxytocin in the third stage of labor. Cochrane Database Syst Rev. 2001;(4).

XX. WHO. WHO recommendations for the prevention and treatment of postpartum haemorrhage. 2012 Jan 1.

XXI. Thornton P, Douglas J. Coagulation in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2010 Jun;24(3):339-52.

XXII. Kongnyuy EJ, Hofman JJ, van den Broek N. Ensuring effective essential obstetric care in resource-poor settings. Trop Doct. 2009 Sep;39(3):163-6.

XXIII. Peitsidis P, Kadir RA. Tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011 Mar;12(4):503-16.

XXIV. Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Fergusson DA, et al.Anti-fibrinolytic use for minimizing perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011 Jan 19;(1).

XXV. Shakur H, Elbourne D, Gülmezoglu M, Alfirevic Z, Ronsmans C, Allen E, et al. The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomized, double-blind placebo-controlled trial. Trials. 2010 Apr 16;11:40.

XXVI. Ducloy-Bouthors AS, Jude B, Duhamel A, et al. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011 Apr 15;15(2).

XXVII. Sentilhes L, Winer N, Azria E, Sénat MV, Le Ray C, Vardon D, et al. Tranexamic acid for the prevention of blood loss after vaginal delivery. N Engl J Med. 2018 Aug 23;379(8):731-42.

XXVIII. Igboke FN, Obi VO, Dimejesi BI, et al. Tranexamic acid for reducing blood loss following vaginal delivery: a double-blind randomized controlled trial. BMC Pregnancy Childbirth. 2022 Mar 18;22(1):178.

XXIX. Mirghafourvand M, Mohammad-Alizadeh S, Abbasali-Zadeh F, Shirdel M. The effect of prophylactic intravenous tranexamic acid on blood loss after vaginal delivery in women at low risk of postpartum haemorrhage: a double-blind randomized controlled trial. Aust N Z J Obstet Gynaecol. 2015 Feb;55(1):53-8.

XXX. Charan J, Biswas T. How to calculate sample size for different study designs in medical research. Indian J Psychol Med. 2013 Apr;35(2):121-6.

XXXI. Yang H, Zheng S, Shi C. Clinical study on the efficacy of tranexamic acid in reducing postpartum blood loss: a randomized comparative, multicenter trial. Chung-Hua Fu Chan Ko Tsa Chih. 2001 Oct;36(10):590-2.

XXXII. Bibi S, Danish N, Fawad A, Jamil M. An audit of primary postpartum haemorrhage. J Ayub Med Coll Abbottabad. 2007 Oct-Dec;19(4):102-6.

XXXIII. Devi VC, Sangeetha V, Ashwini Devi K. Role of tranexamic acid in reducing blood loss in normal labor. Int J Acad Med Pharm. 2023;5(4):306-12.

XXXIV. Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010 Jul 7;(7).

XXXV. Neumann BG, Metgud MC, Hoffman MK, et al. Tranexamic acid to reduce blood loss in women at high risk of postpartum haemorrhage undergoing cesarean delivery-a randomized controlled trial. AJOG Glob Rep. 2024 Jan 22;4(1):100316.

XXXVI. Roy P, Sujatha MS, Bhandiwad A, Biswas B. Role of tranexamic acid in reducing blood loss in vaginal delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):246-50.

XXXVII. Gungorduk K, Asıcıoğlu O, Yıldırım G, Ark C, Tekirdağ AI, Besimoglu B. 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 May;30(5):407-13.

XXXVIII. Heesen M, Böhmer J, Klöhr S, Rossaint R, van de Velde M, Dudenhausen JW, et al. Prophylactic tranexamic acid in parturients at low risk for post-partum haemorrhage: systematic review and meta-analysis. Acta Anaesthesiol Scand. 2014 Sep;58(9):10758.

XXXIX. Mirghafourvand M, Mohammad-Alizadeh S, Abbasali-Zadeh F, Shirdel M. The effect of prophylactic intravenous tranexamic acid on blood loss after vaginal delivery in women at low risk of postpartum haemorrhage: a double-blind randomized controlled trial. Aust N Z J Obstet Gynaecol. 2015 Feb;55(1):53-8.