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临床试验/NCT03476096
NCT03476096Unknown不适用

Sublingual Microcirculation Change in Pregnant Women With or Without High Risk Pregnancy Factors During Pregnancy and Postpartum Period

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年1月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Changes of perfused vessel density

研究概览

简要总结

Sublingual microcirculation change in pregnant women with or without high risk pregnancy factors during pregnancy and postpartum period.

详细描述

Microcirculation system is composed of a group of blood vessels less than 100 um in diameter composed of arterioles, capillaries, veins and other structures. The health of microcirculation system correlates well with the stability of systemic circulation. Perfusio of microcirculation is often affected by major diseases such as sepsis, shock and heart disease. Through various microcirculation monitoring instruments, the investigators can assess the disease severity and prognosis.

Physiological changes during pregnancy will increase the blood volume, stroke volume, and microcirculation. Preeclampsia refers to the development of hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) after 20 weeks of gestation with proteinuria. Severe preeclampsia is associated with impaired endothelial cell circulation throughout the body, and reduced sublingual microcirculation perfusion.

Through the sublingual microcirculation monitor, studies have shown that pregnant women have more microcirculation perfusion than non-pregnant women, while women with severe preeclampsia and those with HELLP syndrome have impaired microcirculation.

This study aims to investigate whether there is any change in the sublingual microcirculation before and after labor in healthy pregnant women and high-risk pregnant women (such as epilepsy, gestational diabetes, etc.) through the third generation of microcirculation imaging microscope (cytocam).

研究设计

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

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy pregnant women older than 20 years old who will delivery baby in our hospital (both normal spontaneous delivery and cesarean section).
  • Women over 20 years of age who will delivery baby in our hospital (both normal spontaneous delivery and cesarean section) and meet the definition of high-risk pregnancy such as gestational diabetes mellitus, placenta previa, placenta accreta, gestational hypertension, preeclampsia or severe preeclampsia.

排除标准

  • Chronic hypertension or diabetes

结局指标

主要结局

Changes of perfused vessel density

时间窗: From the day before delivery to three days after delivery

Changes of perfused vessel density before and after delivery

次要结局

  • Changes of microvascular flow index(From the day before delivery to three days after delivery)
  • Changes of heterogeneity index before(From the day before delivery to three days after delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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