Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.

NCT06604325 | Recruiting

• 1 other identifier: IEC-812
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Perioperative blood loss

  The primary aim of the trial is to investigate the effect of tranexamic acid on peri and post- operative blood loss during caesarean section

  Amount of blood loss from starting from surgical incision till 24 hours post caesarean section.

Study Arms (2)

Group A

ACTIVE COMPARATOR

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: Tranexamic acid injection

Group B

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tranexamic acid injection DRUG

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 A

Placebo DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women posted for elective or emergency caesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aligarh Muslim University: lead

Study Sites (1)

ASJSATDS Medical College

Fatehpur, Uttar Pradesh, 212601, India

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• MUAZZAM HASAN, MD

  AMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUAZZAM HASAN, MD

CONTACT

9808447427; MUAZZAMSH@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)