Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage

NCT ID: NCT07278037

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 648 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-09-30

Brief Summary

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.

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.

Conditions

Postpartum Hemorrhage; Delivery Complication; Cesarean Section Complications; Perinatal Problems

Keywords

cesarean delivery; complications; postpartum hemorrhage; tranexamic acid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Tranexamic acid group

Patients received tranexamic acid after postpartum hemorrhage

Tranexamic acid

Intervention Type: DRUG

The number of patients received tranexamic acid after postpartum hemorrhage

Non tranexamic acid group

Patients did not receive tranexamic acid after postpartum hemorrhage

No interventions assigned to this group

Interventions

Tranexamic acid

The number of patients received tranexamic acid after postpartum hemorrhage

Intervention Type: DRUG

Other Intervention Names

TXA

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patchareya Nivatpumin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Patchareya Nivatpumin, M.D.

Role: CONTACT

Phone: +66896662187

Email: patcahreya.niv@mahidol.ac.th

Premyuda Matangkarat, M.D.

Role: CONTACT

Phone: +66959472598

Email: premyuda.mat@mahidol.ac.th

Facility Contacts

Patchareya Nivatpumin, M.D.

Role: primary

Premyuda Matangkarat, M.D.

Role: backup

Other Identifiers

Si 717/2025

Identifier Type: OTHER

Identifier Source: secondary_id

776/2568(IRB3)

Identifier Type: -

Identifier Source: org_study_id