Role Of Different Prophylactic Doses Of Intravenous Tranexamic Acid In Reducing Blood Loss At Caesarean Section

NCT02739815 | Completed Phase 4

• 1 other identifier: OG1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to define a safe prophylactic intravenous TXA dose with an advantage over others in reducing total blood loss volume at secondary uncomplicated LSCS.

Conditions

Hemorrhage of Cesarean Section and/or Perineal Wound; Postpartum Hemorrhage

Keywords

Caesarean Section; Tranexamic Acid; Postpartum Hemorrhage; Ecbolics

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss Volume

  Estimating Total Blood Loss Volume (ml) during and after Caesarean Section, up to 6 hours post-operative.

  Up to 7 hours

Secondary Outcomes (13)

• Duration of surgery

  Up to One hour

• Hemoglobin level (Hb)

  6 hours

• Maternal weight (W)

  2 hours

• Hematocrit value (Hct)

  6 hours

• Need for blood or blood products transfusion

  Up to 6 hours

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Will receive a placebo (10 ml of distilled water) in Z solution \[500 ml of normal saline containing a prophylactic Antibiotic 1 g\] (At 20 minutes preoperatively).

Drug: Normal Saline containing a prophylactic Antibiotic 1 g

T1

ACTIVE COMPARATOR

Will receive Tranexamic acid 15 mg/kg in Z solution \[500 ml of normal saline containing a prophylactic Antibiotic 1 g\] (At 20 minutes preoperatively).

Drug: Normal Saline containing a prophylactic Antibiotic 1 g; Drug: Tranexamic Acid

T2

ACTIVE COMPARATOR

Will receive Tranexamic acid 20 mg/kg in Z solution \[500 ml of normal saline containing a prophylactic Antibiotic 1 g\] (At 20 minutes preoperatively).

Drug: Normal Saline containing a prophylactic Antibiotic 1 g; Drug: Tranexamic Acid

T3

ACTIVE COMPARATOR

Will receive Tranexamic acid 25 mg/kg in Z solution \[500 ml of normal saline containing a prophylactic Antibiotic 1 g\] (At 20 minutes preoperatively).

Drug: Normal Saline containing a prophylactic Antibiotic 1 g; Drug: Tranexamic Acid

Interventions

Normal Saline containing a prophylactic Antibiotic 1 g DRUG

500 ml of normal saline containing a prophylactic Antibiotic 1 g.

Also known as: Solution of Sodium Chloride 0.9 %

Placebo; T1; T2; T3

Tranexamic Acid DRUG

Tranexamic acid

Also known as: TXA

T1; T2; T3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Maternal average age of 20-40 years.
• Singleton pregnancy at term between 38±5 days and 40 weeks.
• Elective planned or emergency secondary lower segment caesarean sections (LSCS).

You may not qualify if:

• Women with severe medical and surgical complications as any of the following will be excluded :
• Heart, liver, kidney, or brain diseases, and blood disorders.
• Abruptio placenta, and placental abnormalities or accrete syndromes.
• Polyhydramnios, macrosomia, preeclampsia, or allergy to tranexamic acid.
• History of thromboembolic disorders, or severe anemia.

Sponsors & Collaborators

• Talkha Central Hospital: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar University, Faculty of Medicine for Boys ( Cairo ), Al-Hussein University Hospital

Cairo, Cairo Governorate, Egypt

Location

Related Publications (25)

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• Yehia AH, Koleib MH, Abdelazim IA, Atik A. Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial. Asian Pacific Journal of Reproduction. 2014 Mar 31;3(1):53-6.

  BACKGROUND

• Tarabrin O, Kaminskiy V, Galich S, Tkachenko R, Gulyaev A, Shcherbakov S, Gavrychenko D. Efficacy of tranexamic acid in decreasing blood loss during cesarean section. Critical Care. 2012;16(Suppl 1):P439.

  BACKGROUND

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  BACKGROUND

• CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. 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 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

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• 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 Dec;115(3):224-6. doi: 10.1016/j.ijgo.2011.07.015. Epub 2011 Aug 27.

  PMID: 21872857 BACKGROUND

• 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 Fetal Neonatal Med. 2015 Jun;28(9):1014-8. doi: 10.3109/14767058.2014.941283. Epub 2014 Jul 28.

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• Maged AM, Helal OM, Elsherbini MM, Eid MM, Elkomy RO, Dahab S, Elsissy MH. A randomized placebo-controlled trial of preoperative tranexamic acid among women undergoing elective cesarean delivery. Int J Gynaecol Obstet. 2015 Dec;131(3):265-8. doi: 10.1016/j.ijgo.2015.05.027. Epub 2015 Aug 15.

  PMID: 26341174 BACKGROUND

• Wang HY, Hong SK, Duan Y, Yin HM. Tranexamic acid and blood loss during and after cesarean section: a meta-analysis. J Perinatol. 2015 Oct;35(10):818-25. doi: 10.1038/jp.2015.93. Epub 2015 Jul 30.

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• 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 Oct;7(4):427-31. doi: 10.4103/1658-354X.121077.

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• Gibbons L, Belizán JM, Lauer JA, Betrán AP, Merialdi M, Althabe F. The global numbers and costs of additionally needed and unnecessary caesarean sections performed per year: overuse as a barrier to universal coverage. World health report 2010, 30: 1-31.

  BACKGROUND

• WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/

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• Shahid A, Khan A. Tranexamic acid in decreasing blood loss during and after caesarean section. J Coll Physicians Surg Pak. 2013 Jul;23(7):459-62.

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• Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.

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• Topsoee MF, Bergholt T, Ravn P, Schouenborg L, Moeller C, Ottesen B, Settnes A. Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy-a double-blinded randomized placebo-controlled trial. Am J Obstet Gynecol. 2016 Jul;215(1):72.e1-8. doi: 10.1016/j.ajog.2016.01.184. Epub 2016 Jan 30.

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• Sujata N, Tobin R, Kaur R, Aneja A, Khanna M, Hanjoora VM. Randomized controlled trial of tranexamic acid among parturients at increased risk for postpartum hemorrhage undergoing cesarean delivery. Int J Gynaecol Obstet. 2016 Jun;133(3):312-5. doi: 10.1016/j.ijgo.2015.09.032. Epub 2016 Feb 16.

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• Gupta A, Dwivedi Y, Shakya V, Srivastva U, Saxena A, Agarwal AM, et al. Efficacy of Tranexamic Acid in Reducing Perioperative Blood Loss During Caesarean Section: A Placebo Controlled Double Blind Study. International Journal of Scientific Research 2016, 5(3).

  BACKGROUND

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• 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 Jan;22(1):72-5. doi: 10.1080/14767050802353580.

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MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Amro M. Hetta, MS Student

  Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN

  PRINCIPAL INVESTIGATOR

• Mahmoud E. Mohammed, Professor

  Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN

  STUDY DIRECTOR

• Yehia A. Wafa, Chairman

  Al-Azhar University, Faculty of Medicine for boys (Cairo), Departments of OBS/GYN

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Student of Obstetrics and Gynecology, Al-Azhar University

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

EG (1)