drugset / Trial / NCT02350179
Efficacy of Tranexamic Acid in Reducing Blood Loss During and After Caesarean Section
RandomizedParallel-groupDouble-blindPrevention
Summary
The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is Tranexamic acid effective in reducing blood loss during and after elective Caesarean section? The Research Hypothesis The TXA could be able to reduce blood loss during and after elective Caesarean section. The null hypothesis will therefore state that: There will be no difference between TXA and placebo in reducing blood loss during and after elective Caesarean section.
Timeline
- Start
- 2014-06
- Primary completion
- 2015-04
- Completion
- 2015-05
Publications
- Background American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. doi: 10.1097/00006250-200610000-00046.
- Background As AK, Hagen P, Webb JB. Tranexamic acid in the management of postpartum haemorrhage. Br J Obstet Gynaecol. 1996 Dec;103(12):1250-1. doi: 10.1111/j.1471-0528.1996.tb09638.x. No abstract available.
- Background Astedt B. Clinical pharmacology of tranexamic acid. Scand J Gastroenterol Suppl. 1987;137:22-5.
- Background Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesth Analg. 2010 May 1;110(5):1368-73. doi: 10.1213/ANE.0b013e3181d74898. Epub 2010 Mar 17.
- Background Betran AP, Merialdi M, Lauer JA, Bing-Shun W, Thomas J, Van Look P, Wagner M. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007 Mar;21(2):98-113. doi: 10.1111/j.1365-3016.2007.00786.x.
- Background Bingham D. Obstetric hemorrhage-related maternal mortality and morbidity. J Womens Health (Larchmt). 2012 Sep;21(9):901-2. doi: 10.1089/jwh.2012.3873. No abstract available.
- Background Bick D; National Collaborating Centre for Women's and Children's Health; National Institute for Clinical Excellence. Caesarean Section. Clinical Guideline. National Collaborating Centre for Women's and Children's Health: commissioned by the National Institute for Clinical Excellence. Worldviews Evid Based Nurs. 2004;1(3):198-9. doi: 10.1111/j.1524-475X.2004.04060.x. No abstract available.
- Background Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
- Background Lu MC, Fridman M, Korst LM, Gregory KD, Reyes C, Hobel CJ, Chavez GF. Variations in the incidence of postpartum hemorrhage across hospitals in California. Matern Child Health J. 2005 Sep;9(3):297-306. doi: 10.1007/s10995-005-0009-3.
- Background Magann EF, Evans S, Hutchinson M, Collins R, Lanneau G, Morrison JC. Postpartum hemorrhage after cesarean delivery: an analysis of risk factors. South Med J. 2005 Jul;98(7):681-5. doi: 10.1097/01.SMJ.0000163309.53317.B8.
- Background Najmi RS, Rehan N. Prevalence and determinants of caesarean section in a teaching hospital of Pakistan. J Obstet Gynaecol. 2000 Sep;20(5):479-83. doi: 10.1080/014436100434640.
- Background Queenan JT. How to stop the relentless rise in cesarean deliveries. Obstet Gynecol. 2011 Aug;118(2 Pt 1):199-200. doi: 10.1097/AOG.0b013e3182266682. No abstract available.
- Background Vangen S, Bergsjo P. [Do women die from pregnancy these days?]. Tidsskr Nor Laegeforen. 2003 Dec 23;123(24):3544-5. Norwegian.
- Background Mathai M, Gulmezoglu AM, Hill S. Saving womens lives: evidence-based recommendations for the prevention of postpartum haemorrhage. Bull World Health Organ. 2007 Apr;85(4):322-3. doi: 10.2471/blt.07.041962. No abstract available.
- Background Zhang J, Liu Y, Meikle S, Zheng J, Sun W, Li Z. Cesarean delivery on maternal request in southeast China. Obstet Gynecol. 2008 May;111(5):1077-82. doi: 10.1097/AOG.0b013e31816e349e.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1 g | Intravenous |