Actively Recruiting
Prophylactic Role of Tranexamic Acid to Reduce Blood Loss During Caesarean Delivery: A Prospective Study
Led by Aligarh Muslim University · Updated on 2024-10-24
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Postpartum hemorrhage is a leading cause of health complications and death among mothers worldwide, accounting for 25% of pregnancy-related deaths. It can happen unexpectedly even without known risk factors. Researchers are studying tranexamic acid, a medication that helps reduce bleeding, to see if it can decrease blood loss when given before cesarean sections alongside other medicines that help contract the uterus. The study compares two groups of women undergoing cesarean delivery. One group receives 1 gram of tranexamic acid diluted in 100 ml of normal saline through an intravenous infusion 10 minutes before the skin incision. The other group receives a placebo infusion of 100 ml normal saline at the same time. This randomized, double-blind study aims to evaluate the impact of tranexamic acid in preventing excessive bleeding during and after surgery. Participants will be monitored from the start of surgery until 24 hours after the cesarean section to measure the amount of blood lost during this period. Researchers will track and compare bleeding between the groups to assess the effectiveness of tranexamic acid. The total participation duration includes the surgery day and the immediate postoperative period for safety and outcome assessments.
CONDITIONS
Brief Title
Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women undergoing cesarean delivery (elective or emergency) during the study period
- Willing to participate after understanding the study
You will not qualify if you...
- Critically ill patients
- Not willing to give consent
- Diagnosed with ruptured uterus or undergoing cesarean hysterectomy during operation
- Male gender
- Age below 18 or above 45 years old
- Unwilling to participate in the study after explanation of the concept
- Any condition that may prevent safe participation as judged clinically (implied by critically ill status and surgical exclusions, if applicable, but only explicit criteria listed here)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From infusion before incision through 24 hours post cesarean section
Participants receive an intravenous infusion of tranexamic acid or placebo 10 minutes before the cesarean skin incision to reduce blood loss during delivery.
1 treatment visit and monitoring for 24 hours post surgery
Trial Site Locations
Total: 1 location
1
ASJSATDS Medical College
Fatehpur, Uttar Pradesh, India, 212601
Actively Recruiting
Research Team
M
MUAZZAM HASAN, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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