Tranexamic acid for prevention of bleeding in cesarean delivery: An overview of systematic reviews.
cesarean section
hemorrhage
tranexamic acid
Journal
Acta anaesthesiologica Scandinavica
ISSN: 1399-6576
Titre abrégé: Acta Anaesthesiol Scand
Pays: England
ID NLM: 0370270
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
revised:
20
08
2021
received:
09
06
2021
accepted:
24
08
2021
pubmed:
14
9
2021
medline:
27
1
2022
entrez:
13
9
2021
Statut:
ppublish
Résumé
Bleeding is the leading cause of maternal mortality in the world. Tranexamic acid reduces bleeding in trauma and surgery. Several systematic reviews of randomized trials have investigated tranexamic acid in the prevention of bleeding in cesarean delivery. However, the conclusions from systematic reviews are conflicting. This overview aims to summarize the evidence and explore the reasons for conflicting conclusions across the systematic reviews. A comprehensive literature search of Medline, Embase, and Cochrane Database of Systematic Reviews was conducted from inception to April 2021. Screening, data extraction, and quality assessments were performed by two independent reviewers. A Measurement Tool to Assess Reviews 2 and the Risk of Bias Assessment Tool for Systematic Reviews were used for study appraisal. A qualitative synthesis of evidence is presented. In all, 14 systematic reviews were included in our analysis. Across these reviews, there were 32 relevant randomized trials. A modest reduction in blood transfusions and bleeding outcomes was found by most systematic reviews. Overall confidence in results varied from low to critically low. All of the included systematic reviews were at high risk of bias. Quality of evidence from randomized trials was uncertain. Systematic reviews investigating prophylactic tranexamic acid in cesarean delivery are heterogeneous in terms of methodological and reporting quality. Tranexamic acid may reduce blood transfusion and bleeding outcomes, but rigorous well-designed research is needed due to the limitations of the included studies. Data on safety and adverse effects are insufficient to draw conclusions.
Sections du résumé
BACKGROUND
Bleeding is the leading cause of maternal mortality in the world. Tranexamic acid reduces bleeding in trauma and surgery. Several systematic reviews of randomized trials have investigated tranexamic acid in the prevention of bleeding in cesarean delivery. However, the conclusions from systematic reviews are conflicting. This overview aims to summarize the evidence and explore the reasons for conflicting conclusions across the systematic reviews.
METHODS
A comprehensive literature search of Medline, Embase, and Cochrane Database of Systematic Reviews was conducted from inception to April 2021. Screening, data extraction, and quality assessments were performed by two independent reviewers. A Measurement Tool to Assess Reviews 2 and the Risk of Bias Assessment Tool for Systematic Reviews were used for study appraisal. A qualitative synthesis of evidence is presented.
RESULTS
In all, 14 systematic reviews were included in our analysis. Across these reviews, there were 32 relevant randomized trials. A modest reduction in blood transfusions and bleeding outcomes was found by most systematic reviews. Overall confidence in results varied from low to critically low. All of the included systematic reviews were at high risk of bias. Quality of evidence from randomized trials was uncertain.
CONCLUSIONS
Systematic reviews investigating prophylactic tranexamic acid in cesarean delivery are heterogeneous in terms of methodological and reporting quality. Tranexamic acid may reduce blood transfusion and bleeding outcomes, but rigorous well-designed research is needed due to the limitations of the included studies. Data on safety and adverse effects are insufficient to draw conclusions.
Substances chimiques
Antifibrinolytic Agents
0
Tranexamic Acid
6T84R30KC1
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
3-16Subventions
Organisme : The Ottawa Hospital Anesthesia Alternate Funds Association
Organisme : University of Ottawa
Organisme : The Ottawa Hospital
Organisme : University Research Chair
Informations de copyright
© 2021 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
Références
WHO. Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. 2012.
Say L, Chou D, Gemmill A, et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Heal. 2014;2(6):323-333. doi:10.1016/S2214-109X(14)70227-X
WHO, UNICEF, UNFPA TWB. Trends in Maternal Mortality: 1990 to 2015. WHO, UNICEF, UNFPA, World Bank Estim; 2015.
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(7858):1-13. doi:10.1136/bmj.e3054
Henry DA, Carless PA, Moxey AJ, et al. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011;(3):CD001886. doi:10.1002/14651858.CD001886.pub4
Vogel JP, Oladapo OT, Dowswell T, Gülmezoglu AM. Updated WHO recommendation on intravenous tranexamic acid for the treatment of post-partum haemorrhage. Lancet Glob Heal. 2018;6(1):e18-e19. doi:10.1016/S2214-109X(17)30428-X
Muñoz M, Stensballe J, Ducloy-Bouthors A-S, et al. Patient blood management in obstetrics: prevention and treatment of postpartum haemorrhage. A NATA consensus statement. Blood Transfus. 2019;17(2):112-136. doi:10.2450/2019.0245-18
Mavrides E, Allard S, Chandraharan E, et al. Prevention and management of postpartum haemorrhage. BJOG. 2017;124(5):e106-e149. doi:10.1111/1471-0528.14178
Xu J, Gao W, Ju Y. Tranexamic acid for the prevention of postpartum hemorrhage after cesarean section: a double-blind randomization trial. Arch Gynecol Obstet. 2013;287(3):463-468. doi:10.1007/s00404-012-2593-y
Sujata N, Tobin R, Kaur R, et al. Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery. Int J Gynaecol Obstet. 2016;133(3):312-315. doi:10.1016/j.ijgo.2015.09.032
Goswami U, Sarangi S, Gupta S, Babbar 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(4):427-431. doi:10.4103/1658-354X.121077
Gai M, Wu L, Su Q, Tatsumoto K. 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. 2004;112(2):154-157.
Ahmed MR, Sayed Ahmed WA, Madny EH, Arafa AM, Said MM. Efficacy of tranexamic acid in decreasing blood loss in elective caesarean delivery. J Matern Neonatal Med. 2015;28(9):1014-1018. doi:10.3109/14767058.2014.941283
Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gülmezoglu AM. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial. J Matern Neonatal Med. 2013;26(17):1705-1709. doi:10.3109/14767058.2013.794210
Shahid A, Khan A. Tranexamic acid in decreasing blood loss during and after caesarean section. J Coll Physicians Surg Pak. 2013;23(7):459-462.
Sentürk MB, Cakmak Y, Yildiz G, Yildiz P. Tranexamic acid for cesarean section: a double-blind, placebo-controlled, randomized clinical trial. Arch Gynecol Obstet. 2013;287(4):641-645. doi:10.1007/s00404-012-2624-8
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(1):72-75. doi:10.1080/14767050802353580
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(3):224-226. doi:10.1016/j.ijgo.2011.07.015
Maged AM, Helal OM, Elsherbini MM, et al. A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery. Int J Gynaecol Obstet. 2015;131(3):265-268. doi:10.1016/j.ijgo.2015.05.027
Lakshmi SD, Abraham R. Role of prophylactic tranexamic acid in reducing blood loss during elective caesarean section: a randomized controlled study. J Clin Diagn Res. 2016;10(12):17-21. doi:10.7860/JCDR/2016/21702.9050
Halder S, Samanta B, Sardar R, Chattopadhyay S. Tranexamic acid used before caesarean section reduces blood loss based on pre- and postoperative haemoglobin level: a case-control study. J Indian Med Assoc. 2013;111(3):184-186.
Gungorduk K, Yıldırım G, Asıcıoğlu O, et al. 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(3):233-240. doi:10.1055/s-0030-1268238
Ker K, Shakur H, Roberts I. Does tranexamic acid prevent postpartum haemorrhage? A systematic review of randomised controlled trials. BJOG. 2016;123(11):1745-1752. doi:10.1111/1471-0528.14267
Alam A, Choi S. Prophylactic use of tranexamic acid for postpartum bleeding outcomes: a systematic review and meta-analysis of randomized controlled trials. Transfus Med Rev. 2015;29(4):231-241. doi:10.1016/j.tmrv.2015.07.002
Li C, Gong Y, Dong L, Xie B, Dai Z. Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention? A systematic review and meta-analysis. Medicine. 2017;96(1):e5653. doi:10.1097/MD.0000000000005653
Heesen M, Böhmer J, Klöhr S, et al. Prophylactic tranexamic acid in parturients at low risk for post-partum haemorrhage: systematic review and meta-analysis. Acta Anaesthesiol Scand. 2014;58(9):1075-1085. doi:10.1111/aas.12341
Simonazzi G, Bisulli M, Saccone G, et al. Tranexamic acid for preventing postpartum blood loss after cesarean delivery: a systematic review and meta-analysis of randomized controlled trials. Acta Obstet Gynecol Scand. 2016;95(1):28-37. doi:10.1111/aogs.12798
Franchini M, Mengoli C, Cruciani M, et al. Safety and efficacy of tranexamic acid for prevention of obstetric haemorrhage: an updated systematic review and meta-analysis. Blood Transfus. 2018;16:329-337. doi:10.2450/2013.0047-13
Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015;(6). doi:10.1002/14651858.CD007872.pub3
Hunt H, Pollock A, Campbell P, Estcourt L, Brunton G. An introduction to overviews of reviews: planning a relevant research question and objective for an overview. Syst Rev. 2018;7(1):1-9. doi:10.1186/s13643-018-0695-8
Pollock M, Fernandes RM, Pieper D, et al. Preferred Reporting Items for Overviews of Reviews (PRIOR): a protocol for development of a reporting guideline for overviews of reviews of healthcare interventions. Syst Rev. 2019;8(1):335. doi:10.1186/s13643-019-1252-9
Booth A, Clarke M, Ghersi D, et al. An international registry of systematic-review protocols. Lancet. 2011;377(9760):108-109. doi:10.1016/S0140-6736(10)60903-8
Booth A, Clarke M, Dooley G, et al. The nuts and bolts of PROSPERO: an international prospective register of systematic reviews. Syst Rev. 2012;1:2. doi:10.1186/2046-4053-1-2
McGowan J, Sampson M, Salzwedel DM, et al. PRESS peer review of electronic search strategies: 2015 guideline statement. J Clin Epidemiol. 2016;75:40-46. doi:10.1016/j.jclinepi.2016.01.021
Whiting P, Savović J, Higgins JPT, et al. ROBIS: a new tool to assess risk of bias in systematic reviews was developed. J Clin Epidemiol. 2016;69:225-234. doi:10.1016/j.jclinepi.2015.06.005
Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ. 2017;j4008. doi:10.1136/bmj.j4008
Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535. doi:10.1136/BMJ.B2535
Pieper D, Antoine S-L, Mathes T, Neugebauer EAM, Eikermann M. Systematic review finds overlapping reviews were not mentioned in every other overview. J Clin Epidemiol. 2014;67(4):368-375. doi:10.1016/j.jclinepi.2013.11.007
Peitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011;12(4):503-516. doi:10.1517/14656566.2011.545818
Wang Y, Liu S, He L. Prophylactic use of tranexamic acid reduces blood loss and transfusion requirements in patients undergoing cesarean section: a meta-analysis. J Obstet Gynaecol Res. 2019;45(8):1562-1575. doi:10.1111/jog.14013
Stortroen NE, Tubog TD, Shaffer SK. Prophylactic tranexamic acid in high-risk patients undergoing cesarean delivery: a systematic review and meta-analysis of randomized controlled trials. AANA J. 2020;88(4):273-281.
Topsoee MF, Settnes A, Ottesen B, Bergholt T. A systematic review and meta-analysis of the effect of prophylactic tranexamic acid treatment in major benign uterine surgery. Int J Gynecol Obstet. 2017;136(2):120-127. doi:10.1002/ijgo.12047
Wang H-Y, Hong S-K, Duan Y, Yin H-M. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015;35(10):818-825. doi:10.1038/jp.2015.93
Breau RH, Kokolo MB, Punjani N, et al. The effects of lysine analogs during pelvic surgery: a systematic review and meta-analysis. Transfus Med Rev. 2014;28(3):145-155. doi:10.1016/j.tmrv.2014.05.002
Dahlke JD, Mendez-Figueroa H, Rouse DJ, et al. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013;209(4):294-306. doi:10.1016/j.ajog.2013.02.043
Higgins J, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Cochrane, 2019. Available from www.training.cochrane.org/handbook; 2019.
Jadad AR, McQuay HJ. Meta-analyses to evaluate analgesic interventions: a systematic qualitative review of their methodology. J Clin Epidemiol. 1996;49(2):235-243. doi:10.1016/0895-4356(95)00062-3
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995;273(5):408-412. doi:10.1097/00043764-199603000-00007
Ioannidis JPA, Greenland S, Hlatky MA, et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet. 2014;383(9912):166-175. doi:10.1016/S0140-6736(13)62227-8
Sentilhes L, Sénat MV, Le Lous M, et al. Tranexamic acid for the prevention of blood loss after cesarean delivery. N Engl J Med. 2021;384(17):1623-1634. doi:10.1056/NEJMoa2028788