Clinical Trial: Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-invasive Bio-reactance

Brief Summary: The purpose of this study is to determine whether a noninvasive method of measuring certain aspects of blood circulation (e.g., blood pressure, cardiac output) is an accurate and reliable method to detect changes in pregnant patients. Specifically,the investigators are interested in patients diagnosed with high blood pressure during their pregnancy, as compared with normal pregnant patients. A noninvasive, accurate method of taking these measurements in pregnant patients is not currently available.

Detailed Summary:

During pregnancy, many aspects of blood circulation, such as blood pressure, heart rate, cardiac output, and stroke volume, adapt to accommodate the increasing needs of a pregnant body. The circulatory system works harder to provide blood flow to the placenta and the growing fetus.

Currently, the devices that can give physicians detailed information on the status of the blood circulation of normal patients and those with high blood pressure during pregnancy are invasive to varying degrees. However, recently, a new noninvasive hemodynamic monitor (NonInvasive Cardiac Output Monitoring: NICOM) was introduced to the market. In studies with non-pregnant patients, the NICOM has been found to be accurate, precise and reliable. However, it has yet to be studied in the field of Obstetrics.

The purpose of this study is to find out if the NICOM is an effective tool for monitoring hemodynamic changes in pregnant women, both with normal and high blood pressure. We are planning to compare the hemodynamic profiles of normal pregnant patients, hypertensive pregnant patients, and non pregnant patients as a control group. If this monitor proves to be reliable in assessing these changes in the pregnant patients, this could have a great impact in optimizing the care of the patients with different medical conditions in pregnancy, such as increased blood pressure.


Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Current Primary Outcome: Cardiac Index (CI) [ Time Frame: 20 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cardiac Output (CO) [ Time Frame: 20 minutes ]
  • Blood Pressure (BP) [ Time Frame: 20 minutes ]
  • Systemic Vascular Resistance (SVR) [ Time Frame: 20 minutes ]


Original Secondary Outcome: Same as current

Information By: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Dates:
Date Received: July 29, 2009
Date Started: July 2009
Date Completion:
Last Updated: March 25, 2010
Last Verified: March 2010