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Clinical Trial NCT07278037 for Postpartum Hemorrhage, Delivery Complication, Cesarean Section Complications, Perinatal Problems is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage 648 Postpartum

Recruiting
Clinical Trial NCT07278037 is an observational study for Postpartum Hemorrhage, Delivery Complication, Cesarean Section Complications, Perinatal Problems that is recruiting. It started on December 1, 2025 with plans to enroll 648 participants. Led by Mahidol University, it is expected to complete by September 30, 2026. The latest data from ClinicalTrials.gov was last updated on December 22, 2025.
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 tr...Show More
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. S...Show More
Official Title

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

Conditions
Postpartum HemorrhageDelivery ComplicationCesarean Section ComplicationsPerinatal Problems
Other Study IDs
  • 776/2568(IRB3)
  • Si 717/2025 (Other Identifier) (Faculty of Medicine Siriraj Hospital Mahidol University)
NCT ID Number
NCT07278037
Start Date (Actual)
2025-12-01
Last Update Posted
2025-12-22
Completion Date (Estimated)
2026-09-30
Enrollment (Estimated)
648
Study Type
Observational
Status
Recruiting
Keywords
cesarean delivery
complications
postpartum hemorrhage
tranexamic acid
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Tranexamic acid group
Patients received tranexamic acid after postpartum hemorrhage
Tranexamic acid
The number of patients received tranexamic acid after postpartum hemorrhage
Non tranexamic acid group
Patients did not receive tranexamic acid after postpartum hemorrhage
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
Female
  • 1. Patients underwent cesarean delivery with primary postpartum hemorrhage

  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
Mahidol University logoMahidol University
Study Central Contact
Contact: Patchareya Nivatpumin, M.D., +66896662187, [email protected]
Contact: Premyuda Matangkarat, M.D., +66959472598, [email protected]
1 Study Locations in 1 Countries

Bangkok

Siriraj Hospital, Bangkoknoi, Bangkok, 10700, Thailand
Patchareya Nivatpumin, M.D., Contact, +66896662187, [email protected]
Premyuda Matangkarat, M.D., Contact, +66959472598, [email protected]
Recruiting