Back to resultsPrevention of Postpartum Haemorrhage
Primary Purpose
Post Partum Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid injection
Sponsored by
About this trial
This is an interventional prevention trial for Post Partum Hemorrhage focused on measuring tranexamic acid, postpartum hemorrhage, cesarean section
Eligibility Criteria
Inclusion Criteria:
- Women at high risk for postpartum hemorrhage after cesarean section
Exclusion Criteria:
- women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
Sites / Locations
- Police HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study
Control
Arm Description
Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
control group will not be given tranexamic acid
Outcomes
Primary Outcome Measures
blood loss
Estimation of blood loss
Secondary Outcome Measures
blood pressure
blood pressure
pulse
pulse
temperature
temperature
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04463966
Brief Title
Prevention of Postpartum Haemorrhage
Official Title
Tranexamic Acid for the Prevention of Postpartum Haemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial
Detailed Description
This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage
Keywords
tranexamic acid, postpartum hemorrhage, cesarean section
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Active Comparator
Arm Description
Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
Arm Title
Control
Arm Type
No Intervention
Arm Description
control group will not be given tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
Kapron, 500 mg/5ml
Intervention Description
1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
Primary Outcome Measure Information:
Title
blood loss
Description
Estimation of blood loss
Time Frame
immediately after deliver
Secondary Outcome Measure Information:
Title
blood pressure
Description
blood pressure
Time Frame
immediately after delivery
Title
pulse
Description
pulse
Time Frame
immediately after delivery
Title
temperature
Description
temperature
Time Frame
immeditely after delivery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women at high risk for postpartum hemorrhage after cesarean section
Exclusion Criteria:
women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aboubakr Elnashar, MD
Phone
00201066934749
Email
elnashar53@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
shaimaa ezzat
Phone
00201009023289
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa Ezzat
Organizational Affiliation
Police Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Police Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaimaa ezzat
Phone
00201009023289
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prevention of Postpartum Haemorrhage
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