Back to resultsEffectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
Primary Purpose
Bleeding
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional supportive care trial for Bleeding
Eligibility Criteria
Inclusion Criteria:
- - Women undergoing caesarean delivery for various elective indications.
- Full term primiparas / multiparas.
- Singleton pregnancy being delivered by LSCS.
Exclusion Criteria:
- - Medical problems involving the heart, liver, kidney and brain .
- Blood disorders.
- Allergy to tranexamic acid.
- History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
- Multiple pregnancy, macrosomia.
- Polyhydromnios .
- Patients requiring blood transfusion due to anemia
Sites / Locations
- Ain Shams Maternity HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
group A
group B
Arm Description
receiving tranexamic acid
does not receive tranexamic acid
Outcomes
Primary Outcome Measures
Amount of blood loss during cesarean section after placental delivery till end of the operation.
Secondary Outcome Measures
1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
composite
Adverse affect of tranexamic acid on mother and neonate .
eg:drug allergy ,drug interaction ,thrombotic manifestation and the number of participant .
24 hours post operative haemoglobin and haematocrit .
composite
Full Information
NCT ID
NCT02279186
First Posted
October 24, 2014
Last Updated
November 1, 2014
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02279186
Brief Title
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
Official Title
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.
Detailed Description
To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
receiving tranexamic acid
Arm Title
group B
Arm Type
No Intervention
Arm Description
does not receive tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
in 200 ml saline
Intervention Description
Intravenous Injection
Primary Outcome Measure Information:
Title
Amount of blood loss during cesarean section after placental delivery till end of the operation.
Time Frame
during and 2hours post cesarean section
Secondary Outcome Measure Information:
Title
1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
Description
composite
Time Frame
up to 24hours postoperative
Title
Adverse affect of tranexamic acid on mother and neonate .
Description
eg:drug allergy ,drug interaction ,thrombotic manifestation and the number of participant .
Time Frame
first 24 hours
Title
24 hours post operative haemoglobin and haematocrit .
Description
composite
Time Frame
after 24 hours.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Women undergoing caesarean delivery for various elective indications.
Full term primiparas / multiparas.
Singleton pregnancy being delivered by LSCS.
Exclusion Criteria:
- Medical problems involving the heart, liver, kidney and brain .
Blood disorders.
Allergy to tranexamic acid.
History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
Multiple pregnancy, macrosomia.
Polyhydromnios .
Patients requiring blood transfusion due to anemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Shalby, MBBCH
Phone
01121117275
Ext
202
Email
dr_mahmoud.mostafa@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Abdelaziz, M.D
Phone
01001783383
Ext
202
Email
dr_AmrAziz@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Abdelaziz, M.D
Organizational Affiliation
Ain Shams Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashwa AlSaied, M.D
Phone
01005369353
Ext
202
First Name & Middle Initial & Last Name & Degree
Amr Abdelaziz, M.D
Phone
01001783383
Ext
202
Email
dr_AmrAziz@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
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