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

Primary Purpose

Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
normal saline arm group
intravenous tranexamic acid
Topical tranexamic acid
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring cesarean section, tranexamic acid, postpartum hemorrhage

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aswan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

normal saline arm group

intravenous tranexamic acid group

Topical tranexamic acid group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

intraoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods

Secondary Outcome Measures

postoperative blood loss
measurement the intraoperative blood loss by direct and gravimetric methods
need of blood transfusion
number of unites of blood transfusion
need of uterotonic
misoprostol,oxytocin etc
change in hemoglobin

Full Information

First Posted
October 11, 2018
Last Updated
August 3, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03706339
Brief Title
Reducing Blood Loss During Cesarean Section by Topical Versus IV Tranexamic Acid
Official Title
Reducing Blood Loss During Cesarean Section With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
cesarean section, tranexamic acid, postpartum hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal saline arm group
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
intravenous tranexamic acid group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Topical tranexamic acid group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
normal saline arm group
Other Intervention Name(s)
placebo comparator
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
intravenous tranexamic acid
Other Intervention Name(s)
active comparator
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Topical tranexamic acid
Other Intervention Name(s)
active comparator
Intervention Description
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
Primary Outcome Measure Information:
Title
intraoperative blood loss
Description
measures the intraoperative blood loss by direct and gravimetric methods
Time Frame
during the operation
Secondary Outcome Measure Information:
Title
postoperative blood loss
Description
measurement the intraoperative blood loss by direct and gravimetric methods
Time Frame
24 hours postoperative
Title
need of blood transfusion
Description
number of unites of blood transfusion
Time Frame
24 hours postoperative
Title
need of uterotonic
Description
misoprostol,oxytocin etc
Time Frame
during operation
Title
change in hemoglobin
Time Frame
Baseline and 24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women with a single term fetus scheduled for an elective Cesarean section
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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