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Идёт набор NCT07278037

Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage

Наблюдательное Postpartum Hemorrhage Delivery Complication Cesarean Section Complications Perinatal Problems

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tranexamic acid.
Кому может быть актуально
Состояния в реестре: Postpartum Hemorrhage, Delivery Complication, Cesarean Section Complications, Perinatal Problems. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Tranexamic acid
    The number of patients received tranexamic acid after postpartum hemorrhage

Первичные конечные точки

  • Rate of tranexamic acid administration divided by year [Срок оценки: Within 24 hours after delivery]
Вторичные конечные точки (9)
  • Quantity of blood loss [Срок оценки: Within 24 hours after delivery]
  • Number of patients received blood transfusion [Срок оценки: Within 24 hours after delivery]
  • Number of patients received additional obstetrical interventions [Срок оценки: Within 24 hours after delivery]
  • Number of patients receive reoperation [Срок оценки: Within 24 hours after delivery]
  • Causes of postpartum hemorrhage [Срок оценки: Within 24 hours after delivery]
  • Factors influencing tranexamic acid administration [Срок оценки: Within 24 hours after delivery]
  • Side effect of tranexamic acid administration [Срок оценки: After delivery to 30 days]
  • Hospital length of stay [Срок оценки: After delivery to 30 days]
  • Maternal Mortality [Срок оценки: After delivery to 30 days]

Критерии участия

Критерии включения

  • 1\. Patients underwent cesarean delivery with primary postpartum hemorrhage

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Таиланд · 1 центр
  • Siriraj Hospital — Bangkoknoi

Идентификаторы

NCT: NCT07278037 · 776/2568(IRB3) · Si 717/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗