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Postpartum HemorrhageNCT07278037

Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage

An observational study of Postpartum Hemorrhage and Delivery Complication, run by Mahidol University at 1 site in Thailand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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%. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Tranexamic acid
How many people
648 participants
Where
1 siteThailand
Study dates
1 Dec 2025to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 1. Patients underwent cesarean delivery with primary postpartum hemorrhage

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patchareya Nivatpumin, M.D. contact

+66896662187

patcahreya.niv@mahidol.ac.th

Premyuda Matangkarat, M.D. contact

+66959472598

premyuda.mat@mahidol.ac.th

Thailand1 site, 1 recruiting
  • Siriraj Hospital

    Bangkoknoi, Bangkok, 10700

    Patchareya Nivatpumin, M.D., +66896662187, patchareya.niv@mahidol.ac.th

    Premyuda Matangkarat, M.D., +66959472598, premyuda.mat@mahidol.ac.th

    Recruiting

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Tranexamic acid
Keywords
cesarean delivery, complications, postpartum hemorrhage, tranexamic acid
Medical subject headings
Postpartum Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic acidDrug

    Also called TXA

    The number of patients received tranexamic acid after postpartum hemorrhage

Study groups in NCT07278037
Study groupRoleWhat they receive
Tranexamic acid groupPatients received tranexamic acid after postpartum hemorrhage
Receives: Drug: Tranexamic acid
Non tranexamic acid groupPatients did not receive tranexamic acid after postpartum hemorrhage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of tranexamic acid administration divided by year

    Number of patients received tranexamic acid after diagnosis of postpartum hemorrhage

    Measured: Within 24 hours after delivery

Secondary outcomes (9)
  1. Quantity of blood loss

    Quantity of blood loss recorded in patients chart

    Measured: Within 24 hours after delivery

  2. Number of patients received blood transfusion

    Number of patients received packed red cells transfusion

    Measured: Within 24 hours after delivery

  3. 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

    Measured: Within 24 hours after delivery

  4. Number of patients receive reoperation

    Reoperation within 24 hours after cesarean delivery

    Measured: Within 24 hours after delivery

  5. 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

    Measured: Within 24 hours after delivery

  6. Factors influencing tranexamic acid administration

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

    Measured: Within 24 hours after delivery

  7. Side effect of tranexamic acid administration

    Side effect of tranexamic acid administration eg. thromboembolism, stroke

    Measured: After delivery to 30 days

  8. Hospital length of stay

    Hospital length of stay in days

    Measured: After delivery to 30 days

  9. Maternal Mortality

    Maternal death rate if death occur

    Measured: After delivery to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
648 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07278037
Sponsor's protocol ID
776/2568(IRB3)
Other IDs
Si 717/2025
Status last verified
Dec 2025
First submitted
30 Nov 2025
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The plan is undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postpartum Hemorrhage and Delivery Complication, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patchareya Nivatpumin, M.D. (+66896662187, patcahreya.niv@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of tranexamic acid administration divided by year (time frame: Within 24 hours after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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