Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid

Reducing Blood Loss During Cesarean Section With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial

Tranexamic (TXA)acid is an inexpensive, antifibrinolytic drug long used to control bleeding due to surgery, menorrhagia, or trauma. Additionally, tranexamic acid has been shown to reduce bleeding during cesarean delivery as well as the need for additional uterotonic agents, albeit to a minimal degree. However, previous studies have been performed only in women with a standard risk for postpartum hemorrhage( PPH) and have not focused on assessing the effects of tranexamic acid in high-risk women. The aim of this study is to evaluate the efficacy of IV versus topical application of tranexamic acid in reducing blood loss during and after elective C.S. The Research Question Is topical application of Tranexamic acid effective in reducing blood loss during and after an 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 topical and IV TXA and placebo in reducing blood loss during and after elective Caesarean section.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Other: normal saline arm group; Drug: intravenous tranexamic acid; Drug: Topical tranexamic acid

Detailed Description

patients were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min. Throughout the operation, irrigation was done by 60 ml of (2g tranexamic acid (10 ml) diluted in 100 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.).At the end of operation, another dose of 60 ml of (1g tranexamic acid (10 ml) diluted in 50 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.) was left intraabdominal

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• all pregnant women with a single term fetus scheduled for elective cesarean section who will be at risk of postpartum hemorrhage

Exclusion Criteria:

• Patients with a cardiac, hepatic, renal or thromboembolic disease. ,
• patients with the high possibility of the morbid adherent placenta,
• known coagulopathy and
• those presented with severe antepartum hemorrhage
• refuse to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: normal saline arm group; they received 110 ml saline infusion or placebo (110 normal salines) by slow intravenous injection at an approximate rate of 1 mL per min plus Throughout the operation irrigation was done by120 ml saline	Other: normal saline arm group; 110 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the placental bed during Cesarean section; Other Names: placebo comparator
Active Comparator: intravenous tranexamic acid group; 1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus100 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the pelvic bed after Cesarean hysterectomy	Drug: intravenous tranexamic acid; 1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus110 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the pelvic bed during cesarean section; Other Names: active comparator
Experimental: Topical tranexamic acid group; 2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 100 ml normal saline applied on the placental bed after Cesarean section plus110 ml normal saline IV just before skin incision	Drug: Topical tranexamic acid; 2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 120 ml normal saline applied on the pelvic bed during cesarean section plus110 ml normal saline IV just before skin incision; Other Names: active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	measures the intraoperative blood loss by direct and gravimetric methods	during the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative blood loss	measurement the intraoperative blood loss by direct and gravimetric methods	24 hours postoperative
need of blood transfusion	number of unites of blood transfusion	24 hours postoperative
need of uterotonic	misoprostol,oxytocin etc	during operation
change in hemoglobin		Baseline and 24 hours postoperative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: cesarean section; tranexamic acid; postpartum hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: aswu/278/7/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No