Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Location status: Recruiting
Location contact
Patchareya Nivatpumin, M.D.
CONTACT
Premyuda Matangkarat, M.D.
CONTACT
NCT Number: NCT07278037
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.
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Observational
Bangkoknoi, Bangkok, 10700, Thailand
Location status: Recruiting
Patchareya Nivatpumin, M.D.
CONTACT
Premyuda Matangkarat, M.D.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The number of patients received tranexamic acid after postpartum hemorrhage
Other names: TXA
Time frame: Within 24 hours after delivery
Number of patients received tranexamic acid after diagnosis of postpartum hemorrhage
Time frame: Within 24 hours after delivery
Quantity of blood loss recorded in patients chart
Time frame: Within 24 hours after delivery
Number of patients received packed red cells transfusion
Time frame: Within 24 hours after delivery
Number of patients received additional obstetrical interventions such as intrauterine balloon insertion, hysterectomy, uterine artery ligation, B-lynch suture
Time frame: Within 24 hours after delivery
Reoperation within 24 hours after cesarean delivery
Time frame: Within 24 hours after delivery
Causes of postpartum hemorrhage divided into 4 categories, 1: uterine atony; 2: abnormal placentation; 3: trauma to internal organ(s); 4:abnormal coagulation
Time frame: Within 24 hours after delivery
Identify factors influencing tranexamic acid administration eg. history of antepartum hemorrhage, placental cause of PPH etc.
Time frame: After delivery to 30 days
Side effect of tranexamic acid administration eg. thromboembolism, stroke
Time frame: After delivery to 30 days
Hospital length of stay in days
Time frame: After delivery to 30 days
Maternal death rate if death occur
Contact information is provided by the study sponsor or research team.
Patchareya Nivatpumin, M.D.
CONTACT
Premyuda Matangkarat, M.D.
CONTACT
Mahidol University
Other
A Retrospective Analysis of the Longitudinal Pattern of Tranexamic Acid Administration in Parturients Undergoing Cesarean Delivery Complicated by Postpartum Hemorrhage
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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