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Набор скоро начнётся NCT07041385

Comparing the Efficacy of 75mg Versus 150mg Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women

Без фазы С лечением Preeclampsia (PE)

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: Aspirin 75 mg, Aspirin 150 mg.
Кому может быть актуально
Состояния в реестре: Preeclampsia (PE). Базовые параметры: 18 лет — 30 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
Пакистан
Следующий шаг
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Обзор

This study aims to evaluate the effectiveness of 75 mg aspirin versus 150 mg aspirin in preventing preeclampsia among individuals with high risk for the condition. Existing literature suggests that the 150 mg aspirin dose may exhibit superior efficacy, yet inconclusive evidence exists in our local setting.

Подробное описание

Pre-eclampsia is a major factor in both maternal and fetal morbidity and mortality. The most widely investigated preeclampsia prevention medication is low dose Aspirin. However, guidelines differ considerably regarding the prophylactic dose of Aspirin for preeclampsia. Pre-eclampsia (PE) affects 5-7% of all pregnancies and along with eclampsia is the major contributor to maternal morbidity and 10-15% of maternal mortality and also perinatal mortality. Low dose aspirin administration can reduce vasoconstriction and decreases thrombosis of the vessels related to placenta, thereby increases blood flow and protects against to pregnancy related complication like preeclampsia, IUGR or FGR. One of the major therapeutic interventions to prevent preeclampsia is the use of Aspirin (a COX-II inhibitor with anti-inflammatory and anti-thrombotic properties). Initiating low-dose aspirin (LDA) therapy in early pregnancy from 12 weeks can prevent the onset of pre-eclampsia or delay it. The antiplatelet and vasodilatory effect of aspirin induced by the inhibition of cyclooxygenase-1 (COX-1) and reduced production of thromboxane, a potent vasoconstrictor and platelet aggregator, enhances placental blood circulation. Moreover, potential anti-inflammatory properties can improve endothelial dysfunction and oxidative stress, which are the central pieces of preeclampsia mechanisms.

The dose of aspirin used in most hospital settings is low dose, which has its benefits outweigh the risks and side effects of the drug. Many studies evaluated low doses of Aspirin 60-80mg showing a 10%-50% reduction in the incidence of preeclampsia, while a few studies also evaluated the efficacy of a 150mg dose. To our knowledge, this is among very few studies to investigate the effectiveness of relatively higher doses of aspirin in the Pakistani population.

Вмешательства

  • Препарат Aspirin 75 mg
    This study aims to evaluate the effectiveness of 75 mg aspirin versus 150 mg aspirin in preventing preeclampsia among individuals with high risk for the condition. Eligible women attending the antenatal clinic were screened by history, physical exam, and uterine artery Doppler. Risk assessment was entered into the Fetal Medicine Foundation software. Participants were randomized: Group A: 75 mg aspirin nightly. Group B: 150 mg aspirin nightly.
  • Препарат Aspirin 150 mg
    This study aims to evaluate the effectiveness of 75 mg aspirin versus 150 mg aspirin in preventing preeclampsia among individuals with high risk for the condition. Eligible women attending the antenatal clinic were screened by history, physical exam, and uterine artery Doppler. Risk assessment was entered into the Fetal Medicine Foundation software. Participants were randomized: Group A: 75 mg aspirin nightly. Group B: 150 mg aspirin nightly.

Первичные конечные точки

  • Pre - eclampsia [Срок оценки: 9 months]
Вторичные конечные точки (1)
  • Delivery [Срок оценки: 9 months]

Критерии участия

Критерии включения

  • Screen positive women
  • Age 18 - 30 y
  • Gestational Age 11 - 13+6 weeks
  • Singleton Pregnancy
  • Estimated risk for preterm PE of > 1 in 100 (Reference - Fetal Medicine Foundation)

Критерии исключения

  • Screen negative women
  • Age > 30 y
  • Gestational Age > 14 weeks
  • Multiple Gestation
  • Estimated risk for preterm PE of < 1 in 100 (Reference - Fetal Medicine Foundation)

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
Открытое
Основная цель
Профилактика

Центры проведения

Пакистан · 1 центр
  • Shalamar Hospital — Lahore

Идентификаторы

NCT: NCT07041385 · IRB - 830

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗