NCT07278037

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
648

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Dec 2025Sep 2026

First Submitted

Initial submission to the registry

November 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

November 30, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

cesarean deliverycomplicationspostpartum hemorrhagetranexamic acid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Quantity of blood loss

    Within 24 hours after delivery

  • Number of patients received blood transfusion

    Within 24 hours after delivery

  • Number of patients received additional obstetrical interventions

    Within 24 hours after delivery

  • Number of patients receive reoperation

    Within 24 hours after delivery

  • Causes of postpartum hemorrhage

    Within 24 hours after delivery

  • +4 more secondary outcomes

Study Arms (2)

Tranexamic acid group

Patients received tranexamic acid after postpartum hemorrhage

Drug: Tranexamic acid

Non tranexamic acid group

Patients did not receive tranexamic acid after postpartum hemorrhage

Interventions

The number of patients received tranexamic acid after postpartum hemorrhage

Also known as: TXA
Tranexamic acid group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. Patients underwent cesarean delivery with primary postpartum hemorrhage

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Patchareya Nivatpumin, M.D.

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patchareya Nivatpumin, M.D.

CONTACT

Premyuda Matangkarat, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2025

First Posted

December 11, 2025

Study Start

December 1, 2025

Primary Completion

March 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations