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Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.

NCT06604325 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-10-24

No results posted yet for this study

Summary

Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian Section.

Conditions

  • Post Partum Hemorrhage

Interventions

DRUG

Tranexamic acid injection

All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

DRUG

Placebo

All women recruited to Group B will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

Sponsors & Collaborators

  • Aligarh Muslim University

    lead OTHER

Principal Investigators

  • MUAZZAM HASAN, MD · AMU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-03-30
Completion
2025-03-30

Countries

  • India

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604325 on ClinicalTrials.gov