Back to resultsTopical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section
Primary Purpose
Cesarean Section Complications
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical tranexamic acid
: normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Cesarean Section Complications
Eligibility Criteria
Inclusion Criteria:
- hypertensive women undergoing elective cesarean section
Exclusion Criteria:
- Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
- patients with the high possibility of the morbid adherent placenta,
- known coagulopathy and
- those presented with severe antepartum hemorrhage
- refuse to participate
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Topical tranexamic acid
normal saline
Arm Description
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo
temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
Outcomes
Primary Outcome Measures
intraoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods
Secondary Outcome Measures
need of blood transfusion
number of unites of blood transfusion
need of uterotonic
misoprostol, oxytocin etc
change in hemoglobin
change in hemoglobin
Full Information
NCT ID
NCT05072860
First Posted
September 29, 2021
Last Updated
September 29, 2021
Sponsor
Aswan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05072860
Brief Title
Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section
Official Title
The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Hypertensive Women Undergoing Elective Cesarean Section: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In hypertensive women having an elective cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.
Detailed Description
patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a double-blinded randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
a double-blinded randomized controlled trial
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical tranexamic acid
Arm Type
Experimental
Arm Description
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
Intervention Type
Drug
Intervention Name(s)
Topical tranexamic acid
Other Intervention Name(s)
experimental
Intervention Description
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
Intervention Type
Other
Intervention Name(s)
: normal saline
Other Intervention Name(s)
Placebo Comparator
Intervention Description
temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid
Primary Outcome Measure Information:
Title
intraoperative blood loss
Description
measures the intraoperative blood loss by direct and gravimetric methods
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
need of blood transfusion
Description
number of unites of blood transfusion
Time Frame
12 hours
Title
need of uterotonic
Description
misoprostol, oxytocin etc
Time Frame
24 hours
Title
change in hemoglobin
Description
change in hemoglobin
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
hypertensive women undergoing elective cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hypertensive women undergoing elective cesarean section
Exclusion Criteria:
Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
patients with the high possibility of the morbid adherent placenta,
known coagulopathy and
those presented with severe antepartum hemorrhage
refuse to participate
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section
We'll reach out to this number within 24 hrs