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临床试验/NCT07041385
NCT07041385尚未招募不适用

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

Shalamar Hospital1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2025年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
340
试验地点
1
主要终点
Pre - eclampsia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

研究组 & 干预措施

Group A

Experimental

Group A: 75 mg aspirin nightly.

干预措施: Aspirin 75 mg (Drug)

Group B

Experimental

Group B: 150 mg aspirin nightly.

干预措施: Aspirin 150 mg (Drug)

结局指标

主要结局

Pre - eclampsia

时间窗: 9 months

PE (Pre-eclampsia) Yes / No Early Onset - Pre-eclampsia (\<34 weeks) Yes / No Late Onset - Pre-eclampsia (\>34 weeks) Yes / No

次要结局

  • Delivery(9 months)

研究者

发起方
Shalamar Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hafiz Wajahat Naseem

Post Graduate Resident in Gynae and OBS. Department

Shalamar Hospital

研究点 (1)

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