Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage

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

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications; Postpartum Hemorrhage; Delivery Complication; Perinatal Problems
• Intervention / Treatment: Drug: Tranexamic acid

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 648

Contacts and Locations

• Study Contact: Name: Patchareya Nivatpumin, M.D.; Phone Number: +66896662187; Email: patcahreya.niv@mahidol.ac.th
• Study Contact Backup: Name: Premyuda Matangkarat, M.D.; Phone Number: +66959472598; Email: premyuda.mat@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Siriraj Hospital
      • Contact: Patchareya Nivatpumin, M.D.; Phone Number: +66896662187; Email: patchareya.niv@mahidol.ac.th
      • Contact: Premyuda Matangkarat, M.D.; Phone Number: +66959472598; Email: premyuda.mat@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent cesarean delivery with diagnosis of primary postpartum hemorrhage at Siriraj Hospital, Bangkok, Thailand

Description

Inclusion Criteria:

• 1. Patients underwent cesarean delivery with primary postpartum hemorrhage

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tranexamic acid group; Patients received tranexamic acid after postpartum hemorrhage	Drug: Tranexamic acid; The number of patients received tranexamic acid after postpartum hemorrhage; Other Names: TXA
Non tranexamic acid group; Patients did not receive tranexamic acid after postpartum hemorrhage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of tranexamic acid administration divided by year	Number of patients received tranexamic acid after diagnosis of postpartum hemorrhage	Within 24 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of blood loss	Quantity of blood loss recorded in patients chart	Within 24 hours after delivery
Number of patients received blood transfusion	Number of patients received packed red cells transfusion	Within 24 hours after delivery
Number of patients received additional obstetrical interventions	Number of patients received additional obstetrical interventions such as intrauterine balloon insertion, hysterectomy, uterine artery ligation, B-lynch suture	Within 24 hours after delivery
Number of patients receive reoperation	Reoperation within 24 hours after cesarean delivery	Within 24 hours after delivery
Causes of postpartum hemorrhage	Causes of postpartum hemorrhage divided into 4 categories, 1: uterine atony; 2: abnormal placentation; 3: trauma to internal organ(s); 4:abnormal coagulation	Within 24 hours after delivery
Factors influencing tranexamic acid administration	Identify factors influencing tranexamic acid administration eg. history of antepartum hemorrhage, placental cause of PPH etc.	Within 24 hours after delivery
Side effect of tranexamic acid administration	Side effect of tranexamic acid administration eg. thromboembolism, stroke	After delivery to 30 days
Hospital length of stay	Hospital length of stay in days	After delivery to 30 days
Maternal Mortality	Maternal death rate if death occur	After delivery to 30 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Patchareya Nivatpumin, M.D., Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Estimated): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: complications; tranexamic acid; postpartum hemorrhage; cesarean delivery
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 776/2568(IRB3); Si 717/2025 (Other Identifier: Faculty of Medicine Siriraj Hospital Mahidol University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan is undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No