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Recruiting

NCT Number: NCT06604325

Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ASJSATDS Medical College

Fatehpur, Uttar Pradesh, 212601, India

Location status: Recruiting

Location contact

ASJSATDS Medical College

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Perioperative blood loss

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

MUAZZAM HASAN, MD

CONTACT

[email protected]

9808447427

Sponsors and collaborators

Lead sponsor

Aligarh Muslim University

Other

Registry information

Official study title

Prophylactic Role Of Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery : A Prospective Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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