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临床试验/NCT01351428
NCT01351428已完成不适用

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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Systemic vascular resistance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

NICOM group

Experimental

Vasodilator therapy begins when SVR increases by 20% or greater than baseline. Therapy is titrated according to hemodynamic profile and clinical signs and symptoms.

干预措施: Nifedipine (Drug)

结局指标

主要结局

Systemic vascular resistance

时间窗: 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.

次要结局

  • Gestational age at peak maternal blood pressure(20-41 weeks)
  • Gestational age at time of first hospitalization(25-41 weeks gestational age)
  • Maximum change in maternal blood pressure(20-22, 24-26, 28, 30-32 and 36 weeks gestational age)
  • Gestational age at delivery(25-41 weeks gestational age)
  • Fetal weight at delivery(25-41 weeks gestational age)
  • Gestational age at which steroids are administered(25-41 weeks gestational age)
  • Serum s-Flt and PlGF levels(12-41 weeks gestational age)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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