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Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia

Non-invasive Hemodynamic Monitoring and Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia

Preeclampsia is associated with significant maternal and fetal morbidity and mortality. Early identification and subsequent management of patients at risk of developing preeclampsia presents an ongoing challenge in prenatal care. Some at risk pregnancies may be identified from:

  • serum screening abnormalities in the first or second trimester
  • placental shape and texture at the 18-20 anatomical ultrasound
  • uterine artery blood flow.

Early identification and effective treatment of patients would permit the safe completion of the pregnancy for the mother and infant. Recent advances in non-invasive cardiovascular monitoring have enabled the study of maternal hemodynamics in normal and at-risk pregnancies. This study hopes to identify the earliest significant changes in maternal hemodynamics which may allow targeted therapeutic interventions in patients at high risk of developing preeclampsia.

The hypothesis of this study is that systemic vascular resistance rises during the pre-clinical phase of preeclampsia and this can be captured using non invasive bioreactance technology. Treatment of the abnormally high vascular tone may decrease the severity and postpone the onset of clinical disease.

研究概览

地位

完全的

干预/治疗

详细说明

Invasive hemodynamic techniques have long identified significant increases in heart rate (HR), blood volume, left ventricular end-diastolic volume (LVEDV), stroke volume (SV) and cardiac output (CO) during the first and second trimesters of pregnancy. In normal pregnancy, CO increases from as early as 5 weeks gestation, with a 30-40% increase by the end of the first trimester of pregnancy. Cardiac output continues to rise throughout the second trimester until it reaches a level approximately 50% greater than that of non-pregnant women. Cardiac output slightly decreases during the third trimester. Despite these changes, maternal blood pressure (BP) still falls due to a large reduction in systemic vascular resistance (SVR) from systemic vasodilatation and the formation of a low-resistance utero-placental circulation. Systemic vascular resistance falls during early gestation, reaching its nadir (35% decline) at 20 weeks gestation, and rises during late pregnancy.

Transthoracic bioreactance is a newer technique of non-invasive continuous cardiac output monitoring. It is based on an analysis of relative phase shifts of oscillating currents that occur when this current traverses the thoracic cavity, as opposed to the traditional bioimpedance-based system, which rely only on measured changes in signal amplitude. Unlike bioimpedance, bioreactance-based non-invasive CO measurement does not use the static impedance and does not depend on the distance between the electrodes for the calculations of SV and CO, which significantly reduces the uncertainty in the result. Moreover, its readings were shown to correlate well with results derived from pulmonary artery catheter derived measurement of cardiac output. In addition, it has also been shown that the non-invasive cardiac output measurement (NICOM®) system has acceptable accuracy, precision and responsiveness for CO monitoring in patients experiencing a wide range of circulatory situations and has recently been used in the obstetric population.

The purpose of this study is to use non-invasive cardiac output monitoring to capture the earliest inappropriate rise in SVR during the pre clinical phase of disease, in patients at high risk of developing preeclampsia, as predicted by the placenta profile. In case an increase in SVR is identified, the purpose of this study is to implement a goal-directed therapy in an attempt to decrease the severity, and postpone the onset of clinical disease.

The hypothesis of this study is that the increases in SVR detected during the pre-clinical phase of preeclampsia can be treated with a goal directed therapy without fetal compromise and that this intervention may improve maternal and fetal/neonatal outcome.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

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

    • Ontario
      • Toronto、Ontario、加拿大、M5G1X5
        • Mount Sinai 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 至 50年 (成人)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Risk factors for preeclampsia/IUGR - medical or obstetric
  • Abnormal uterine artery Doppler
  • Two of the following:

Abnormal placental biochemistry Abnormal placental shape Abnormal placental texture

Exclusion Criteria:

  • Multifetal pregnancy
  • Fetal abnormality, including nuchal translucency more than 3mm at 12 weeks
  • Preterm labor/pprom/bleeding/rescue cerclage (excluding elective 12 week prophylactic cerclage)
  • Type 1 diabetes mellitus
  • Heparin use
  • Chronic hypertension on treatment before 20 weeks
  • Documented chronic renal disease

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

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:NICOM group
Vasodilator therapy begins when SVR increases by 20% or greater than baseline. Therapy is titrated according to hemodynamic profile and clinical signs and symptoms.
30-60 mg, twice daily
其他名称:
  • Adalat XL

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
Systemic vascular resistance
大体时间:20-22, 24-26, 28, 30-32 and 36 weeks gestational age
Systemic vascular resistance is measured at the above time points, and more frequently at the discretion of the attending obstetrician.
20-22, 24-26, 28, 30-32 and 36 weeks gestational age

次要结果测量

结果测量
措施说明
大体时间
Maximum change in maternal blood pressure
大体时间:20-22, 24-26, 28, 30-32 and 36 weeks gestational age
Blood pressure is taken on the NICOM at the above time points, and more frequently at obstetric appointments in between.
20-22, 24-26, 28, 30-32 and 36 weeks gestational age
Gestational age at delivery
大体时间:25-41 weeks gestational age
25-41 weeks gestational age
Fetal weight at delivery
大体时间:25-41 weeks gestational age
25-41 weeks gestational age
Gestational age at time of first hospitalization
大体时间:25-41 weeks gestational age
25-41 weeks gestational age
Gestational age at peak maternal blood pressure
大体时间:20-41 weeks
20-41 weeks
Gestational age at which steroids are administered
大体时间:25-41 weeks gestational age
25-41 weeks gestational age
Serum s-Flt and PlGF levels
大体时间:12-41 weeks gestational age
12-41 weeks gestational age

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。

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

2010年12月1日

初级完成 (实际的)

2012年11月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2011年5月9日

首先提交符合 QC 标准的

2011年5月9日

首次发布 (估计)

2011年5月10日

研究记录更新

最后更新发布 (估计)

2012年11月12日

上次提交的符合 QC 标准的更新

2012年11月8日

最后验证

2012年11月1日

更多信息

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.

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