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临床试验/NCT06413576
NCT06413576已完成不适用

The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients

Ain Shams University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
homocysteine level

研究概览

简要总结

Preeclampsia is a disorder characterized by the new onset of hypertension and proteinuria typically presenting after 20 weeks of gestation. Elevated circulating homocysteine is a risk factor for endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Our study is to investigate the association between elevated blood homocysteine levels and complications in pregnant women in order to conclude the clinical utility of homocysteine as a marker of severity in the cases of pre-eclampsia.

详细描述

Hypertensive disorders of pregnancy are an important cause of morbidity and mortality among mothers and infants. Preeclampsia is a pregnancy-related hypertensive disorder occurring usually after 20 weeks of gestation. It is associated with fetal growth restriction, low birth weight, preterm birth, respiratory distress syndrome, and admission to a neonatal intensive care unit. According to a systemic review and meta-analysis published in 2013, preeclampsia has a noticeable relationship with an increased risk of developing hypertension, ischemic heart disease, and cerebrovascular accident in later life.

There is already abundant evidence indicating that elevated serum homocysteine levels may be related to the risk of coronary, cerebral, and peripheral arterial diseases. Elevated circulating homocysteine is a risk factor of endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Normally, homocysteine levels decline throughout pregnancy and since the vascular alterations brought on by homocysteine are comparable to those brought on by hypertensive disorders of pregnancy, it can be assumed that high levels of homocysteine are linked to the hypertensive disorder spectrum. Homocysteine has been shown to produce oxidative stress and endothelial dysfunction, endothelial cell injury and thrombus formation and thereby producing pre-eclampsia.

Estimation of homocysteine may help to predict and prevent pre-eclampsia and eclampsia, thus reducing the undesired outcome of pregnancy.

Among various studies, there is a lack of consistency in the reported results that support the link between maternal homocysteine concentrations assessed throughout each of the three trimesters of pregnancy and difficulties caused by the placenta.

our study investigate the relation between the level of homocysteine and severity of preeclampsia.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • All patients diagnosed by preeclampsia will be included in light of the following diagnostic criteria (blood pressure more than 140\90 mm\Hg on 2 occasions at least 4 hours apart after 20 weeks' gestation in a previously normotensive patient accompanied by Protein/creatinine ratio ≥0.3 .

排除标准

  • Essential hypertension suggested by history or documentation of hypertension in pre pregnant state or hypertension before 20 weeks of gestation.
  • Cardiovascular or renal failure
  • Liver failure
  • Diabetes mellitus
  • Inflammatory or infective disorders
  • History or documentation of epilepsy in prepregnant state
  • Space occupying lesion in brain like tuberculoma or brain tumor
  • Trauma to brain
  • Hyperpyrexia
  • On treatment with antifolate drugs such as methotrexate

结局指标

主要结局

homocysteine level

时间窗: within 24 hours postoperative(post delivery)

Quantitative measurement of the serum level of homocysteine. The measurement will be done using a commercially available sandwich enzyme linked immunosorbent assay (ELIZA) kit supplied by ( Bioassay technology laboratory) according to the manufacturer's instructions.nthe results will be expressed in ng/ml. Absorbance of standards and samples were measured at 450 nm using a microtiter plate ELISA reader .

次要结局

  • Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsia(within 24 hours postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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