Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-Invasive Bio-Reactance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00949260|
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : March 26, 2010
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-invasive Bio-reactance|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Normal, non-pregnant patients will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
Normal, pregnant patients in their 3rd trimester will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
Pregnant patients in their 3rd trimester with pregnancy-induced hypertension that has not been treated will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
- Cardiac Index (CI) [ Time Frame: 20 minutes ]
- Cardiac Output (CO) [ Time Frame: 20 minutes ]
- Blood Pressure (BP) [ Time Frame: 20 minutes ]
- Systemic Vascular Resistance (SVR) [ Time Frame: 20 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949260
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator:||Jose Carvalho, MD||Mount Sinai Hospital, New York|