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Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major

Primary Purpose

Hemorrhage From Placenta Previa, With Delivery

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Tranexamic acid injection
Normal Saline 0.9%
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhage From Placenta Previa, With Delivery

Eligibility Criteria

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

Inclusion Criteria:

  • all placenta previa major pregnant women

Exclusion Criteria:

  1. Any cardiac disorder or liver disease
  2. Patient on anticoagulant therapy
  3. History of allergy to tranexamic acid
  4. Any contraindication for tranexamic acid

Sites / Locations

  • Universiti Kebangsaan Malaysia Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid group

Control group

Arm Description

Tranexamic acid group will receive 1g slow bolus of tranexamic acid over 2 minutes at least 5 minutes before skin incision (at the end of spinal/general anaesthesia)

The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid)

Outcomes

Primary Outcome Measures

To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major
Amount of blood loss in mls
To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major
changes of haemoglobin level

Secondary Outcome Measures

To evaluate the side effects of tranexamic acid
platelet count

Full Information

First Posted
April 10, 2020
Last Updated
January 9, 2021
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04350645
Brief Title
Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major
Official Title
Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 24, 2020 (Actual)
Primary Completion Date
December 23, 2021 (Anticipated)
Study Completion Date
December 23, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia
Detailed Description
Tranexamic acid is a promising agent, easy to administer, cheap, and can be added to the other routine management in hospitals deliveries. This study aims to document the efficacy of intravenous tranexamic acid in reducing blood loss during and after caesarean section in placenta praevia major patients and to assess the Hb and platelet change after its administration. General objective: To investigate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section for placenta praevia major Specific objectives: To evaluate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section up to 2 hours after Caesarean section. To evaluate the drop in Haemoglobin level postoperatively with the use of prophylactic IV tranexamic acid for Caesarean section for PP major To examine the effect of tranexamic acid on platelet level for caesarean section for PP major To observe the side effects of tranexamic acid This study will be conducted at University Kebangsaan Malaysia Medical Centre (UKMMC). Patients who meet the inclusion criteria will be invited to participate in the study. Patient will be given the information sheet regarding the study and consent will be taken if agreeable to participate. Patients' demographic data will be recorded. Patients will be classified randomly into two groups using a computer-generated randomization system (Microsoft Office Excel). The list of randomization will be concealed and numbered on sealed opaque envelopes. Each number will be given a readily prepared 10ml syringe of colourless solution, which could either contain the tranexamic acid or placebo. Each patient will be assigned a serial identification number. The data will be analysed using the Statistical Package for Social Sciences (SPSS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage From Placenta Previa, With Delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid group
Arm Type
Active Comparator
Arm Description
Tranexamic acid group will receive 1g slow bolus of tranexamic acid over 2 minutes at least 5 minutes before skin incision (at the end of spinal/general anaesthesia)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid)
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
1g slow bolus of tranexamic acid over 2 minutes
Intervention Type
Drug
Intervention Name(s)
Normal Saline 0.9%
Intervention Description
10mls normal saline 0.9% over 2 minutes
Primary Outcome Measure Information:
Title
To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major
Description
Amount of blood loss in mls
Time Frame
24 hours
Title
To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major
Description
changes of haemoglobin level
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
To evaluate the side effects of tranexamic acid
Description
platelet count
Time Frame
one week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all placenta previa major pregnant women Exclusion Criteria: Any cardiac disorder or liver disease Patient on anticoagulant therapy History of allergy to tranexamic acid Any contraindication for tranexamic acid
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kah Teik Chew
Phone
+60391455951
Ext
5951
Email
drchewkt@ukm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kah Teik Chew
Organizational Affiliation
UKM Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kah Teik Chew

12. IPD Sharing Statement

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Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major

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