Optic Nerve Sheath Measurement and Angiogenic Factors for the Diagnosis of Pre-eclampsia
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
- 是
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
Subjects admitted for normal labor, without any criteria of pre-eclampsia
干预措施: ONSD+AF (Procedure)
Pre-eclampsia
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
Osvaldo A. Reyes T.
Head of the research deparment
Saint Thomas Hospital, Panama
