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NCT00949260 Clinical Trial

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

Hypertension, Pregnancy-Induced Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00949260
Other study ID # 09-01
Secondary ID
Status Completed
Phase N/A
First received July 29, 2009
Last updated March 25, 2010
Start date July 2009
Est. completion date December 2009

Study information
Verified date March 2010
Source Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- PIH diagnosed in 3rd trimester, not yet treated

- healthy pregnant patients in 3rd trimester

- healthy non-pregnant women

Exclusion Criteria:

- under age 18 or above age 40

- refusal to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Mount Sinai Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac Index (CI) 20 minutes No
Secondary Cardiac Output (CO) 20 minutes No
Secondary Blood Pressure (BP) 20 minutes No
Secondary Systemic Vascular Resistance (SVR) 20 minutes No
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