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

NCT03706339 | Completed

• 1 other identifier: aswu/278/7/18
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section Complications

Keywords

cesarean section; tranexamic acid; postpartum hemorrhage

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss

  measures the intraoperative blood loss by direct and gravimetric methods

  during the operation

Secondary Outcomes (4)

• postoperative blood loss

  24 hours postoperative

• need of blood transfusion

  24 hours postoperative

• need of uterotonic

  during operation

• change in hemoglobin

  Baseline and 24 hours postoperative

Study Arms (3)

normal saline arm group

PLACEBO COMPARATOR

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

intravenous tranexamic acid group

ACTIVE COMPARATOR

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

Topical tranexamic acid group

EXPERIMENTAL

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

Interventions

normal saline arm group OTHER

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

Also known as: placebo comparator

normal saline arm group

intravenous tranexamic acid DRUG

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

Also known as: active comparator

intravenous tranexamic acid group

Topical tranexamic acid DRUG

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

Also known as: active comparator

Topical tranexamic acid group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: pregnant women with a single term fetus scheduled for an elective Cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

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

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: November 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: August 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)