Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
Primary Purpose
Placenta Previa
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
About this trial
This is an interventional prevention trial for Placenta Previa focused on measuring Cesarean section, placenta previa, Tranexamic acid
Eligibility Criteria
Inclusion Criteria:
- Term pregnancy (more than 37 weeks of gestation)
- Diagnosis of placenta previa was confirmed by ultrasound
- The patient hemoglobin percentage is more than 10 mg/dl
Exclusion Criteria:
- Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
- Emergency lower segment cesarean section
- Associated medical comorbidities
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Cases
Controls
Arm Description
Tranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa
Control group will not receive Tranexamic acid
Outcomes
Primary Outcome Measures
intra operative blood loss in ml
Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss
Secondary Outcome Measures
Full Information
NCT ID
NCT03060889
First Posted
January 10, 2017
Last Updated
February 21, 2017
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03060889
Brief Title
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
Official Title
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
Detailed Description
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa to detect efficacy of Tranexamic acid in decreasing blood loss
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
Keywords
Cesarean section, placenta previa, Tranexamic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Active Comparator
Arm Description
Tranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Control group will not receive Tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
10 mg/kg body weight will be given with induction of anesthesia by intravenous infusion
Primary Outcome Measure Information:
Title
intra operative blood loss in ml
Description
Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss
Time Frame
intraoperative during cesarean section
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Term pregnancy (more than 37 weeks of gestation)
Diagnosis of placenta previa was confirmed by ultrasound
The patient hemoglobin percentage is more than 10 mg/dl
Exclusion Criteria:
Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
Emergency lower segment cesarean section
Associated medical comorbidities
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa
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