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临床试验/NCT06122220
NCT06122220已完成不适用

Optic Nerve Sheath Measurement and Angiogenic Factors for the Diagnosis of Pre-eclampsia

Saint Thomas Hospital, Panama2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Optic nerve sheath diameter cut off value

研究概览

简要总结

Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. Refining the diagnostic capability of this test would further improve maternal-fetal outcomes and the use of optic nerve sheath diameter (ONSD) measurement could make the difference.

The purpose of the present study is to correlate the measurement of ONSD with serum angiogenic factor (AF) values in patients with pre-eclampsia and to determine its predictive ability for adverse perinatal outcomes.

研究设计

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

入排标准

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

入选标准

  • Pregnant women between 24 and 40 weeks of gestation.

排除标准

  • Multiple gestation
  • Maternal vasculitis
  • Previous cesarean section (3 or more)
  • Brain or eye tumors
  • Neurological conditions
  • Chronic renal disease
  • Heart disease

研究组 & 干预措施

Control

Active Comparator

Subjects admitted for normal labor, without any criteria of pre-eclampsia

干预措施: ONSD+AF (Procedure)

Pre-eclampsia

Experimental

Subjects admitted with severe pre-eclampsia, based on the criteria by the American College of Obstetricians and Gynecologists (ACOG)

干预措施: ONSD+AF (Procedure)

结局指标

主要结局

Optic nerve sheath diameter cut off value

时间窗: Up to discharge. On average, 7 days.

Value in mms of the optic nerve sheath diameter for the diagnosis of severe preeclampsia

sFLT-1/PiGF index

时间窗: Up until discharge. On average, 7 days

Value of the index between the sFlt-1/PIGF (angiogenic factor) for the diagnosis of severe preeclampsia

次要结局

  • Maternal/fetal morbidity(Up until discharge. On average, 7 days)
  • Neonatal morbidity(Up until discharge. On average, 3 days)

研究者

发起方
Saint Thomas Hospital, Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osvaldo A. Reyes T.

Head of the research deparment

Saint Thomas Hospital, Panama

研究点 (2)

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