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Could the Cerebral Oximetry be a Good Technology to Measure Placental Oxygenation?

2016年4月14日 更新者:Christian Loubert、Maisonneuve-Rosemont Hospital

Could the Cerebral Oximetry (NIRS) be a Good Technology to Measure Placental Oxygenation in Pregnant Woman?

To assess the potential of the cerebral oximeter to measure placental oxygenation

研究概览

地位

完全的

详细说明

There is general agreement among experts to recommend the use of phenylephrine as first line therapy for the treatment of arterial hypotension induced by spinal anaesthesia during caesarean delivery. In some studies, there are trends toward a lower PaO2 values in the umbilical cord venous blood when the mother receive this vasopressor. These findings may be a result of the vasoconstrictor effect of phenylephrine on utero-placental vessels, and a subsequent increased oxygen extraction by the fetus. The possibility to extract more oxygen would provide a certain "safety margin" in the event of compromised utero-placental blood flow during normal pregnancy. However, this "safety margin" should not be taken for granted in cases where signs of fetal distress are present, and this situation might influence the choice of vasopressors.

It is well establish on a physiological basis that during labour, utero-placental blood flow is lower during the contractions. This lower blood flow could result in a lower saturation value measured by the cerebral oximeter.

Twenty patients in labour will be included in this study. Patients will be recruited in obstetric clinic during pregnancy. Based on the second trimester ultrasound, patients with anterior placenta will be included.

During labour, once a functional epidural is in place, an Invos oximeter will be install. Two sensors will be applied on the abdomen (one above the placenta and the other above the myometrium at a place without placenta). Two sensors will also be applied on the extremities (forearm and leg).Saturation values and timing of the contractions will be recorded for sixty minutes. Half of the recording will be done with an oxygen mask. Vitals signs will also be registered every five minutes.

研究类型

观察性的

注册 (实际的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
        • Maisonneuve Rosemont Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

非概率样本

研究人群

healthy pregnant woman at term gestation in labour

描述

Inclusion Criteria:

  • healthy pregnant woman (ASA I or II)
  • Term gestation ( > 37 weeks)
  • Normal pregnancy
  • vaginal delivery
  • obstetrical epidural in place
  • anterior placenta

Exclusion Criteria:

  • patient refusal
  • Any contraindication to neuraxial anesthesia
  • cesarean section
  • multiple gestation
  • placentation abnormalities
  • anormal placental perfusion
  • Placental Abruption

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
anterior placenta

Cerebral oximetry device used to obtain:

Saturation value of the placenta probe with no oxygen, saturation value of the placenta probe with oxygen, saturation value of the myometrium probe with no oxygen saturation value of the myometrium probe with oxygen saturation value of the forearm probe with no oxygen, saturation value of the forearm probe with oxygen saturation value of the leg probe with no oxygen saturation value of the leg probe with oxygen Timing between the contractions measure by cardiotocography

tissue saturation measurement in pregnant women
其他名称:
  • 近红外光谱
  • INVOS

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Difference between Δp and Δm
大体时间:60 minutes
Δp = Difference between the mean value area under the curve for the placenta and arm = (Ap- Af) Δm= Difference between the mean value area under the curve for the myometrium and arm = (Am- Af)
60 minutes

次要结果测量

结果测量
措施说明
大体时间
Difference of the area under the curve of saturation with and without oxygen
大体时间:60 minutes
Ap with Oxygen - Ap without oxygen; Am with oxygen - Am without oxygen
60 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Christian Loubert, MD, FRCPC、Maisonneuve-Rosemont Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年4月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2013年4月15日

首先提交符合 QC 标准的

2013年4月15日

首次发布 (估计)

2013年4月18日

研究记录更新

最后更新发布 (估计)

2016年4月15日

上次提交的符合 QC 标准的更新

2016年4月14日

最后验证

2016年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • LoubertHMR2013/04

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

cerebral oximetry的临床试验

3
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