Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa
Primary Purpose
Postpartum Haemorrage Sever Bleeding After Delivery
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Haemorrage Sever Bleeding After Delivery focused on measuring obstetric bleeding placenta previa
Eligibility Criteria
Inclusion Criteria:
- age 18 -38 Body mass index <30 , Diagnosis of placenta previa
Exclusion Criteria:
- patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy .
other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus.
type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
tranexamic acid group
placebo group
Arm Description
tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section
the control group will receive 500 cc of ringer lactate 20 minute before cesarean section
Outcomes
Primary Outcome Measures
Amount of Actual blood loss in each group
observational
Secondary Outcome Measures
Difference in haemoglobin before operation and 24 hours after operation
observational
Full Information
NCT ID
NCT02688127
First Posted
February 17, 2016
Last Updated
February 17, 2016
Sponsor
Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT02688127
Brief Title
Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa
Official Title
Efficacy of Tranexamic Acid In Reducing Blood Loss Among Pregnant Women During Cesarean Section Because Of Placenta Previa
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluate role of tranexamic acid in reducing blood loss among pregnant women undergoing cesarean section because of placenta previa .Half of participants will receive tranexamia acid drug While the other half will receive placebo.
Detailed Description
Tranexamic Acid used in the field of obstetrics to decrease blood loss during and after cesarean section .
Tranexamic Acid is an antifibrinolytic agent which cause reversible and competitive blockade of the lysine binding sites in plasminogen molecules . It is a synthetic analog of amino acid lysine and its action is to reduce blood loss
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Haemorrage Sever Bleeding After Delivery
Keywords
obstetric bleeding placenta previa
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tranexamic acid group
Arm Type
Experimental
Arm Description
tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
the control group will receive 500 cc of ringer lactate 20 minute before cesarean section
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
cyclo kapron
Intervention Description
tranexamic acid or placebo are given before cesarean section in patient with placenta previa
Primary Outcome Measure Information:
Title
Amount of Actual blood loss in each group
Description
observational
Time Frame
6hour after operation
Secondary Outcome Measure Information:
Title
Difference in haemoglobin before operation and 24 hours after operation
Description
observational
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 -38 Body mass index <30 , Diagnosis of placenta previa
Exclusion Criteria:
patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy .
other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus.
type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy of Tranexamic Acid In Reducing Blood Loss During Cesarean Section Because Of Placenta Previa
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