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Идёт набор NCT05562609

Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women At Higher Risk

Фаза III С лечением Postpartum Hemorrhage

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, Placebo.
Кому может быть актуально
Состояния в реестре: Postpartum Hemorrhage. Базовые параметры: от 18 лет · 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
Tanzania
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Tranexamic Acid by the Intramuscular or Intravenous Route for the Prevention of Postpartum Haemorrhage in Women At Increased Risk: a Randomised, Double-blind, Placebo-controlled Trial

Обзор

Heavy bleeding after childbirth, known as a postpartum haemorrhage (PPH), causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The I'M WOMAN trial is a research study to see whether giving TXA just before childbirth will stop women developing PPH. The trial will assess the effects of intramuscular (IM) and intravenous (IV) tranexamic acid on PPH, side effects and other important maternal health outcomes.

Подробное описание

Postpartum haemorrhage (PPH) causes about 70,000 maternal deaths every year. Tranexamic acid (TXA) is a lifesaving treatment for women with PPH. The WOMAN trial recruited over 20,000 women with PPH and found that intravenous (IV) TXA given soon after PPH onset, reduces bleeding deaths by about a third. Early TXA also reduces blood loss in surgery and death due to bleeding after traumatic injury. The World Health Organization recommends that all women with PPH should receive TXA as a first line treatment.

TXA is more effective when given soon after the bleeding starts. Every fifteen minute delay reduces the survival benefit by about 10%. This suggests that giving TXA around the time of childbirth might prevent PPH. Although several clinical trials have examined the effectiveness of TXA for the prevention of PPH, the results are inconclusive. Trials of tranexamic acid for PPH prevention give the trial treatment after cord clamping, which may be too late to prevent bad bleeding in some women, as bleeding tends to happen soon after childbirth. Because PPH only affects a small proportion of births, the healthcare community need good evidence on the balance of benefits and harms in this population before using TXA to prevent PPH.

The I'M WOMAN trial will evaluate the effects of TXA for PPH prevention in women with one or more risk factors for PPH having a vaginal or caesarean birth. The trial will also evaluate the effect of the route of TXA administration. TXA is usually given by slow IV injection. However, recent research shows that TXA is well tolerated and rapidly absorbed after IM injection, achieving therapeutic blood levels within minutes of injection. There may be fewer side effects with IM TXA because peak blood concentrations are lower than with the IV route, as well as practical advantages.

Вмешательства

  • Препарат Tranexamic acid
    Ampoules and packaging for all arms will be identical in appearance.
  • Другое Placebo
    Ampoules and packaging for all arms will be identical in appearance.

Первичные конечные точки

  • Risk of Postpartum haemorrhage [Срок оценки: within 24 hours of childbirth]

Критерии участия

Критерии включения

  • Women aged 18 years or older who are admitted to hospital to give birth vaginally or by caesarean section, who have one or more known risk factors for PPH

Критерии исключения

  • Women who have a clear indication or contraindication for TXA

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Профилактика

Центры проведения

Tanzania · 1 центр
  • Mbeya Regional Referral Hospital — Mbeya

Публикации

  • Larson NJ, Mergoum AM, Dries DJ, Cook A, Blondeau B, Rogers FB. THE ROLE OF TRANEXAMIC ACID IN POSTPARTUM HEMORRHAGE: A NARRATIVE REVIEW. Shock. 2024 Nov 1;62(5):620-627. doi: 10.1097/SHK.0000000000002455. Epub 2024 Aug 20. PMID 39162220
  • Brenner A, Shakur-Still H, Chaudhri R, Muganyizi P, Olayemi O, Arribas M, Kayani A, Javid K, Bello A, Roberts I; I'M WOMAN Trial Collaborative Group. Tranexamic acid by the intramuscular or intravenous route for the prevention of postpartum haemorrhage in women at increased risk: a randomised placebo-controlled trial (I'M WOMAN). Trials. 2023 Dec 3;24(1):782. doi: 10.1186/s13063-023-07687-1. PMID 38044460

Идентификаторы

NCT: NCT05562609 · IMWOMAN

Первоисточники (государственные реестры)

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