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NCT Number: NCT07278037

Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage

Postpartum hemorrhage (PPH) is the global leading cause of maternal death, with 20-30% of maternal deaths in Thailand linked to hemorrhage. The WOMAN Trial (2017) provided strong evidence that administering tranexamic acid (TXA)within three hours of bleeding onset lowered PPH-related mortality by 31%. Consequently, the World Health Organization (WHO) updated its guidelines, recommending TXA as part of the standard treatment package for all PPH cases. Following this, the use of TXA has been widely adopted globally and increased in Thailand. A recent study at a major Thai university hospital observed a significant increase in TXA administration after 2017. The current study aims to further analyze the recent growth rate of TXA use and its impact on obstetric and perinatal outcomes during cesarean deliveries with PPH.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

About this study

Postpartum hemorrhage (PPH) is the foremost global cause of maternal mortality and represents a critical public health challenge. While the frequency of PPH varies worldwide, its prevalence remains markedly higher in developing nations. For instance, in Thailand, maternal death rates were reported between 20.0 and 40.5 per 100,000 deliveries from 1990 to 2015, with PPH accounting for 20% to 30% of these fatalities. Standard care for PPH involves fluid resuscitation, vital sign monitoring, uterotonic medications, and various non-surgical or surgical procedures. Within this framework, tranexamic acid (TXA), an antifibrinolytic agent, has gained substantial clinical recognition as an effective pharmacological treatment for PPH.

The therapeutic utility of TXA was strongly validated by the pivotal World Maternal Antifibrinolytic Trial (WOMAN Trial), a large international randomized controlled trial published in 2017. This landmark study definitively showed that administering TXA within three hours of bleeding onset resulted in a statistically significant 31% reduction in mortalityspecifically related to hemorrhage in PPH cases. This compelling evidence immediately prompted the World Health Organization (WHO) to update its clinical recommendations. The revised WHO guideline now advocates for the use of TXA as soon as possible in all PPH cases, regardless of the delivery method, integrating it into the standard comprehensive treatment protocol.

In the wake of this influential global recommendation, numerous healthcare systems and clinical institutions have revised their PPH management algorithms to incorporate TXA. Consequently, the utilization of tranexamic acid has demonstrably increased across several countries, including Thailand. A recent secondary analysis conducted at a major Thai university hospital, which reviewed 649 PPH cases following cesarean deliveries (2016-2020), confirmed a statistically significant surge in TXA administration after the 2017 WHO guideline change. Although patients receiving TXA were typically those with a greater history of antepartum hemorrhage and significantly higher measured blood loss, the study noted no corresponding change in adverse maternal outcomes, such as rates of blood transfusions, massive hemorrhage, hysterectomy, or intensive care unit admissions.

The present study aims to further analyze and update the data, specifically delineating the recent temporal trend in TXA administration and thoroughly evaluating the comprehensive influence of the WHO recommendations on local obstetric hemorrhage management and associated perinatal outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Patients underwent cesarean delivery with primary postpartum hemorrhage

Exclusion criteria

  • Gestational age at less than 24 weeks
  • Absence of the anesthetic record
  • Received tranexamic acid in the antepartum period
  • Blood loss less than 1,000 ml

Treatment and study plan

Tranexamic Acid

Drug

The number of patients received tranexamic acid after postpartum hemorrhage

Other names: TXA

Primary outcomes

  1. Rate of tranexamic acid administration divided by year

    Time frame: Within 24 hours after delivery

    Number of patients received tranexamic acid after diagnosis of postpartum hemorrhage

Secondary outcomes

  1. Quantity of blood loss

    Time frame: Within 24 hours after delivery

    Quantity of blood loss recorded in patients chart

  2. Number of patients received blood transfusion

    Time frame: Within 24 hours after delivery

    Number of patients received packed red cells transfusion

  3. Number of patients received additional obstetrical interventions

    Time frame: Within 24 hours after delivery

    Number of patients received additional obstetrical interventions such as intrauterine balloon insertion, hysterectomy, uterine artery ligation, B-lynch suture

  4. Number of patients receive reoperation

    Time frame: Within 24 hours after delivery

    Reoperation within 24 hours after cesarean delivery

  5. Causes of postpartum hemorrhage

    Time frame: Within 24 hours after delivery

    Causes of postpartum hemorrhage divided into 4 categories, 1: uterine atony; 2: abnormal placentation; 3: trauma to internal organ(s); 4:abnormal coagulation

  6. Factors influencing tranexamic acid administration

    Time frame: Within 24 hours after delivery

    Identify factors influencing tranexamic acid administration eg. history of antepartum hemorrhage, placental cause of PPH etc.

  7. Side effect of tranexamic acid administration

    Time frame: After delivery to 30 days

    Side effect of tranexamic acid administration eg. thromboembolism, stroke

  8. Hospital length of stay

    Time frame: After delivery to 30 days

    Hospital length of stay in days

  9. Maternal Mortality

    Time frame: After delivery to 30 days

    Maternal death rate if death occur

Study contacts

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

Patchareya Nivatpumin, M.D.

CONTACT

[email protected]

+66896662187

Premyuda Matangkarat, M.D.

CONTACT

[email protected]

+66959472598

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A Retrospective Analysis of the Longitudinal Pattern of Tranexamic Acid Administration in Parturients Undergoing Cesarean Delivery Complicated by Postpartum Hemorrhage

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2025
Registry last updated
Dec 22, 2025

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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