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临床试验/NCT01291342
NCT01291342已完成不适用

Detection and Identification of Preeclampsia Via Volatile Biomarkers

The Nazareth Hospital, Israel1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Volatile Biomarkers

研究概览

简要总结

Preeclampsia is a form of hypertension that is unique to human pregnancy. The incidence of the disease ranges between 2 and 7 percent in healthy nulliparous women. The etiology of preeclampsia is unknown.

Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most likely to be involved.

More than 100 clinical, biophysical, and biochemical tests have been recommended to predict or identify the patient at risk for the future development of the disease.

The results of the pooled data for the various tests and the lack of agreement between serial tests suggest that none of these clinical tests is sufficiently reliable for use as a screening test in clinical practice. As a result there is obviously a great need to develop a novel technology for the early detection of this pregnancy complication before its clinical manifestations appear. An early detection can help in early treatment to prevent or at least minimize the sequel of this disease.

The aim of this project is the early detection of "Preeclampsia" and other pregnancy complications using volatile biomarkers appearing in exhaled breath and/or blood samples, using a simple and inexpensive toll termed NA-NOSE.

Phase-I: The primary phase of this project is the comparison between volatile biomarkers' patterns of pregnant women suffering from "Preeclampsia", pregnant women that are considered to have "Normal Pregnancy", and healthy "Non-Pregnant" women.

Phase-II: The secondary phase of this project is the ability to predict "Preeclampsia", as compared, head-to-head, with other potential predictors used in the current clinical practice.

详细描述

Preeclampsia is a form of hypertension that is unique to human pregnancy. The clinical findings of preeclampsia can manifest as either a maternal syndrome (hypertension and proteinuria with or without other multisystem abnormalities) or as a fetal syndrome (fetal growth restriction, reduced amniotic fluid, and abnormal oxygenation).

The incidence of preeclampsia ranges between 2 and 7 percent in healthy nulliparous women. In these women, preeclampsia is generally mild, with the onset near term or intrapartum (75 percent of cases), and the condition conveys only a minimally increased risk for adverse pregnancy outcome. In contrast, the incidence and severity of preeclampsia are substantially higher in women with multifetal gestation, chronic hypertension, previous preeclampsia, pregestational diabetes mellitus, and in those with preexisting thrombophilias.

The etiology of preeclampsia is unknown. Many theories have been suggested, but most of them have not withstood the test of time. Some of these theories: Abnormal trophoblast invasion, coagulation abnormalities, vascular endothelial damage, cardiovascular maladaptation, immunologic phenomena, genetic predisposition and dietary deficiencies or excesses.

Preeclampsia is a clinical syndrome that embraces a wide spectrum of signs and symptoms that have been clinically observed to develop alone or in combination. The classic triad of preeclampsia includes: hypertension, proteinuria, and edema. However, there is now universal agreement that edema should not be considered as part of the diagnosis of preeclampsia. The diagnosis of preeclampsia requires the presence of an elevated blood pressure (BP) with proteinuria,3 usually starting after the 20th week of the pregnancy, but the severity of the disease process is generally based on the maternal BP which is considered as the traditional hallmark for diagnosis of the disease.

Women with preeclampsia may exhibit a symptom complex ranging from minimal BP elevation to derangements of multiple organ systems. The renal, hematologic, and hepatic systems are most likely to be involved.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All participants are nonsmokers, non obese, young women between 18 and 40 years old who'll be able to provide breath samples.

排除标准

  • Women taking medicines or antioxidants are excluded except the pregnant women who are on traditional prenatal vitamins and those in the preeclampsia group on antihypertensive medication.
  • Obese women or those with chronic diseases and those with a history of chronic hypertension, insulin-dependent diabetes or renal disease are excluded.
  • minors and insane

结局指标

主要结局

Volatile Biomarkers

时间窗: Volatile Biomarkers will be collected from pregnant women and analysed afterward

次要结局

未报告次要终点

研究者

发起方
The Nazareth Hospital, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwan Hakim

DoCTOR

The Nazareth Hospital, Israel

研究点 (1)

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