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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07278037
Enrollment
648
Registered
2025-12-11
Start date
2025-12-01
Completion date
2026-09-30
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cesarean delivery, complications, postpartum hemorrhage, tranexamic acid

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.

Interventions

DRUGTranexamic acid

The number of patients received tranexamic acid after postpartum hemorrhage

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of tranexamic acid administration divided by yearWithin 24 hours after deliveryNumber of patients received tranexamic acid after diagnosis of postpartum hemorrhage

Secondary

MeasureTime frameDescription
Number of patients received blood transfusionWithin 24 hours after deliveryNumber of patients received packed red cells transfusion
Number of patients received additional obstetrical interventionsWithin 24 hours after deliveryNumber of patients received additional obstetrical interventions such as intrauterine balloon insertion, hysterectomy, uterine artery ligation, B-lynch suture
Number of patients receive reoperationWithin 24 hours after deliveryReoperation within 24 hours after cesarean delivery
Causes of postpartum hemorrhageWithin 24 hours after deliveryCauses of postpartum hemorrhage divided into 4 categories, 1: uterine atony; 2: abnormal placentation; 3: trauma to internal organ(s); 4:abnormal coagulation
Quantity of blood lossWithin 24 hours after deliveryQuantity of blood loss recorded in patients chart
Side effect of tranexamic acid administrationAfter delivery to 30 daysSide effect of tranexamic acid administration eg. thromboembolism, stroke
Hospital length of stayAfter delivery to 30 daysHospital length of stay in days
Maternal MortalityAfter delivery to 30 daysMaternal death rate if death occur
Factors influencing tranexamic acid administrationWithin 24 hours after deliveryIdentify factors influencing tranexamic acid administration eg. history of antepartum hemorrhage, placental cause of PPH etc.

Countries

Thailand

Contacts

Primary ContactPatchareya Nivatpumin, M.D.
patcahreya.niv@mahidol.ac.th+66896662187
Backup ContactPremyuda Matangkarat, M.D.
premyuda.mat@mahidol.ac.th+66959472598

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026