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临床试验/NCT03567551
NCT03567551已完成不适用

Novel Biomarkers of Preeclampsia: Aquaporin, Fatty Acid, and S100B

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2017年5月15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
126
试验地点
1
主要终点
S100B protein fragments in maternal blood plasma

研究概览

简要总结

This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.

详细描述

There is a paucity of biomarkers to predict preeclampsia and for predicting the severity of preeclampsia. This study was designed to identify novel biomarkers for both the prediction of preeclampsia in previously normal pregnancies and for the prediction of the severity of preeclampsia in preeclamptic women. The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence and the investigators also plan testing for novel markers using various approaches such as proteomics, lipidomics and genomics. The targeted markers will include Aquaporin 4 (AQP4), soluble aquaporin fragments, chemokines, and halogenated fatty acids in the plasma and/or spinal fluid. Aquaporin fragments and AQP4 have been hypothesized to correlate with severe headaches which are complications of severe preeclampsia. The investigators found in their murine studies that there is a correlation between the presence of halogenated fatty acids in the plasma and elevated blood pressure in a murine model of preeclampsia. The approaches will complement the targeted analyses to identify novel markers that have not been predicted yet.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Greater than or equal to 20 years of age
  • Greater than 24 weeks of gestation
  • Obstetrics/Anesthesia Team had decided that Combined Spinal/Epidural (CSE) or Spinal Anesthesia will be performed

排除标准

  • Pre-pregnancy comorbidities:
  • hypertension, diabetes, or pulmonary hypertension
  • use of steroids, beta blockers, Ca channel antagonist, anticoagulants
  • cardiac or vascular conditions
  • severe headaches or visual disturbances
  • Inability to receive CSE or Spinal Anesthesia
  • Chorioamnionitis, fever, bronchitis, pneumonia

结局指标

主要结局

S100B protein fragments in maternal blood plasma

时间窗: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence

Aquaporin 4 protein fragments in maternal blood plasma

时间窗: Between hospital admission and prior to epidural or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

Aquaporin 4 protein fragments in cerebrospinal fluid

时间窗: At the time of spinal or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

S100B protein fragments in cord blood and placental samples

时间窗: Between delivery and 2 hours after delivery

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

S100B protein fragments in cerebrospinal fluid

时间窗: At the time of spinal or combined spinal/epidural anesthesia

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

Aquaporin 4 protein fragments in cord blood and placental samples

时间窗: Between delivery and 2 hours after delivery

The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence

次要结局

  • Fatty Acids in cerebrospinal fluid(during epidural or combined spinal/epidural anesthesia)
  • Fatty acids in maternal blood(Between hospital admission and prior to epidural or combined spinal/epidural anesthesia)
  • Fatty acids in cord blood and placental samples(Between immediately post-delivery and 2 hours after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tekuila Carter

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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