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临床试验/NCT05474326
NCT05474326Unknown不适用

Amniotic Fluid Index and Fetal Doppler Indices Measurment After Application of Intermittent Pneumatic Compression Device on Lower Limbs in Pregnant Women With Oligohydramnios

Western Galilee Hospital-Nahariya0 个研究点目标入组 30 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
pulsatility index in fetal middle cerebral artery

研究概览

简要总结

the study will examine the effect of application of intermittent pneumatic pressure device on lower limbs on the amniotic fluid amount and fetal doppler indices in women with oligohydramnios

详细描述

oligohydramnios is diagnosed based on ultrasonographic finding of amniotic fluid index less than 5 cm.

Etiologies of oligohydramnios includes infection with viruses such as rubella, cytomegalo virus or parasites such as toxoplasma. other etiologies includes rupture of membranes or fetal malformatios especially urinary tract anomalies. in addition, placental insuffiency may lead to oligohydramnios and can be diagnosed through abnormal doppler measures in the umbilical and middle cereberal arteries. when these etiologies are excluded oligohydramnios is considered to be idiopathic.

The Kendall SCD™ 700 Smart Compression™ Controller is an intermittent pneumatic compression (IPC) device which delivers compression to the legs and feet to aid in the prevention of Venous Thromboembolism in at-risk patient.

previous studies had shown that intermittent pneumatic compression device may increase cardiac output through preload increase.

the study hypothesis that after the application of IPC there will be an improvement in the preload and cardiac which will lead to an increase in placental perfusion and eventually will lead to increase in amniotic fluid amount and improvement in fetal doppler measurement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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 with a diagnosis of oligohydramnios

排除标准

  • fetal malformation
  • rupture of membranes
  • documented viral infection with rubella, cytomegalovirus, herpes simplex, toxoplsma in pregnancy

结局指标

主要结局

pulsatility index in fetal middle cerebral artery

时间窗: one hour

Pulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the fetal middle cerebral artery will be calculated before the application of IPC on lower maternal limbs PI of the fetal middle cerebral artery will be re-calculated after the application of IPC on lower maternal limbs for one hour

amniotic fluid index

时间窗: one hour

basline amniotic fluid index (AFI in centemeters) will be calculated before the application of IPC on lower maternal limbs amniotic fluid index (AFI in centemeters) will be re-calculated after the application of IPC on lower maternal limbs for one hour

pulsatility index in maternal uterine artery

时间窗: one hour

Pulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the maternal uterine artery will be calculated before the application of IPC on lower maternal limbs PI of the maternal uterine artery will be re-calculated after the application of IPC on lower maternal limbs for one hour

pulsatility index in fetal umbilical artery

时间窗: one hour

Pulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the fetal umbilical artery will be calculated before the application of IPC on lower maternal limbs PI of the fetal umbilical artery will be re-calculated after the application of IPC on lower maternal limbs for one hour

pulsatility index in fetal renal artery

时间窗: one hour

Pulsed wave high-resolution color Doppler uhrasonography will be used to identify and to obtain blood flow velocity waveforms. PI will be calculated from the difference in the systolic and diastolic flow velocity divided by the mean flow velocity baseline PI of the fetal renal artery will be calculated before the application of IPC on lower maternal limbs PI of the fetal renal artery will be re-calculated after the application of IPC on lower maternal limbs for one hour

次要结局

未报告次要终点

研究者

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

Inshirah Sgayer

Dr. Inshirah Sgayer

Western Galilee Hospital-Nahariya

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