Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.

Not Applicable

Recruiting

• Conditions: Post Partum Hemorrhage
• Interventions: Drug: Tranexamic acid injection; Drug: Placebo

• Registration Number: NCT06604325
• Lead Sponsor: Aligarh Muslim University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. The women undergoing cesarean delivery (both elective and emergency) during the study period.
2. Willing to participate in the study after understanding the concept.

Exclusion Criteria

1. Critically ill patient.
2. Not willing to give consent to participate in the study
3. Cases diagnosed with a ruptured uterus or undergoing caesarian hysterectomy during operation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	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.
Group B	Placebo	All women recruited to Group A will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision, as placebo.

Primary Outcome Measures

Name	Time	Method
Perioperative blood loss	Amount of blood loss from starting from surgical incision till 24 hours post caesarean section.	The primary aim of the trial is to investigate the effect of tranexamic acid on peri and post- operative blood loss during caesarean section

Trial Locations

Locations (1)

ASJSATDS Medical College; 🇮🇳 Fatehpur, Uttar Pradesh, India