Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section
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
1 other identifier
interventional
150
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedFirst Posted
Study publicly available on registry
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedOctober 11, 2021
September 1, 2021
1.7 years
September 29, 2021
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
intraoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods
30 minutes
Secondary Outcomes (3)
need of blood transfusion
12 hours
need of uterotonic
24 hours
change in hemoglobin
24 hours
Study Arms (2)
Topical tranexamic acid
EXPERIMENTALtemporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo
normal saline
PLACEBO COMPARATORtemporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
Interventions
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid
Eligibility Criteria
You may qualify if:
- hypertensive women undergoing elective cesarean section
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- a double-blinded randomized controlled trial
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- A Professor
Study Record Dates
First Submitted
September 29, 2021
First Posted
October 11, 2021
Study Start
October 1, 2021
Primary Completion
June 30, 2023
Study Completion
September 30, 2023
Last Updated
October 11, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share