A clinical trial to assess the blood loss in women predisposed to postpartum hemorrhage with the use of prophylactic intravenous tranexamic acid

Authors

  • K. Satyasri Department of Obstetrics and Gynecology, Vydehi Institute of Medical Sciences and Research Centre, Bangalore, Karnataka, India
  • Chandana C. Department of Obstetrics and Gynecology, Oxford Medical College Hospital and Research Centre Bangalore, Karnataka, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20230538

Keywords:

Indirect method of quantification of blood loss, Postpartum hemorrhage, Tranexamic acid

Abstract

Background: Postpartum hemorrhage (PPH), a complication encountered during third stage of labour, contributes to 25% of maternal death worldwide. Despite various measures for prevention and management of PPH, burden of PPH still looms.

Methods: Prospective randomized controlled clinical trial (RCT) was conducted in Vydehi Institute of Medical Sciences, among 128 patients predisposed to PPH, over 18 months. After meeting the inclusion and exclusion criteria, participants were randomized to receive tranexamic acid (TXA) intravenously 10 mg/kg along with 10 IU of oxytocin following the delivery. Patients were analysed for, blood loss, need for medical or surgical interventions.

Results: Parameters like age, mean gestational age at haemoglobin estimation, and at delivery were similar among groups. The need or parenteral iron, blood transfusions, uterine artery ligation and compression suture were higher in controls group, but not statistically significant. Among the cesarean section (CS) group, most significant pre-disposing factors for PPH were previous CS (p value=0.012) and anaemia (p value =0.01). Incidence of PPH 0.69% (p value =0.031) and use of additional uterotonics were statistically significant (p value <0.05). Among the vaginal delivery (VD) group, most significant pre-disposing factors were anaemia (p value =0.002), thrombocytopenia (p value =0.045), and fetal-macrosomia (p value =0.020). Incidence of PPH 0.25% (p value <0.001) and use of additional uterotonics and hospital stay were statistically significant.

Conclusions: We conclude that, anemic patients were at higher risk of PPH irrespective of the mode of delivery. Prophylactic TXA lowers incidence of PPH, blood loss, use of additional uterotonics and hospital stay even in the presence of pre-disposing factors. Quantification of blood loss is better estimated by drop in haemoglobin after 24 hours.

References

de Guzman R, Polykratis IA, Sondeen JL, Darlington DN, Cap AP, Dubick MA. Stability of TXA after 12-week storage at temperatures from -20°C to 50°C. Prehosp Emerg Care. 2013;17(3):394-400.

World Health Organization. WHO recommendations for the prevention and treatment of postpartum haemorrhage. Geneva: WHO; 2012.

Durmaz A, Komurcu N. Relationship between maternal characteristics and postpartum hemorrhage: a meta-analysis study. J Nurs Res. 2018;26(5):362-72.

World Health Organisation (WHO), the International Confederation of Midwives (ICM) and the International Federation of Gynaecology and Obstetrics (FIGO). Making pregnancy safer: the critical role of the skilled attendant. World Health Organ. 2007;4:1-8.

Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, et al. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of TXA on death, vascular occlusive events, and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013;17(10):1-79.

WHO, UNICEF, UNFPA, The World Bank Group and the United Nations Population Division, Trends in Maternal Mortality:2000 to 2022, WHO, Geneva; 2023.

Schack SM, Elyas A, Brew G, Pettersson KO. Experiencing challenges when implementing active management of third stage of labor (AMTSL): a qualitative study with midwives in Accra, Ghana. BMC Pregnan Childbirth. 2014;14(1):1-10.

Sexual and Reproductive Health and Research, Human Reproduction Programme (HRP). WHO Postpartum Hemorrhage (PPH) Summit. HRP Project Brief 29th September 2022. Available from: https://www.who.int/publications/m/item/who-postpartum-haemorrhage-(pph)-summit. Accessed on 2 March 2022.

Theunissen F, Cleps I, Goudar S, Qureshi Z, Owa OO, Mugerwa K, et al. Cost of hospital care of women with postpartum haemorrhage in India, Kenya, Nigeria and Uganda: a financial case for improved prevention. Reprod Health. 2021;18:1-8.

Watts G. Utako Okamoto. Lancet. 2016;387(10035):2286.

Kaur A, Bhalla M, Sarkar R. Tranexamic acid in melasma: a review. Pigment Int. 2020;7(1):12.

Pabinger I, Fries D, Schöchl H, Streif W, Toller W. Tranexamic acid for treatment and prophylaxis of bleeding and hyperfibrinolysis. Wiener Klinische Wochenschrift. 2017;129:303-16.

Diaz V, Abalos E, Carroli G. Methods for blood loss estimation after vaginal birth. Cochrane Database Syst Rev. 2018(9).

Jaramillo S, Montane‐Muntane M, Capitan D, Aguilar F, Vilaseca A, Blasi A, et al. Agreement of surgical blood loss estimation methods. Transfusion. 2019;59(2):508-15.

Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, et al. High-dose TXA reduces blood loss in postpartum hemorrhage. Crit Care. 2011;15:117.

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(03):233-40.

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;379(8):731-42.

Gungorduk K, Asıcıoğlu O, Yıldırım G, Ark C, Tekirdağ Aİ, Besımoglu 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;30(05):407-14.

Roy P, Sujatha MS, Bhandiwad A, Biswas B. Role of tranexamic acid in reducing blood loss in vaginal delivery. J Obstet Gynecol India. 2016;66:246-50.

Pfizer. Cyklokapron (tranexamic acid injection): US prescribing information. Available from: https://labeling.pfizer.com/showlabeling.aspx?id=556. Accessed on 2 March 2022.

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Published

2023-02-27

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Section

Original Research Articles