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

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00949260
First received: July 29, 2009
Last updated: March 25, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition
Hypertension, Pregnancy-Induced

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-invasive Bio-reactance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Cardiac Index (CI) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac Output (CO) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • Blood Pressure (BP) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
  • Systemic Vascular Resistance (SVR) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal, Non-Pregnant
Normal, non-pregnant patients will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
Normal, Pregnant
Normal, pregnant patients in their 3rd trimester will have 15 minutes of monitoring at rest, followed by a passive leg raising test.
Pregnant, PIH
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Our study population includes healthy non-pregnant and pregnant patients in their 3rd trimester, as well as pregnant patients in their 3rd trimester with pregnancy-induced hypertension (PIH). Both normal groups will be recruited from the outpatient day-unit (healthy volunteers). Patients with PIH may be sent to labour and delivery for monitoring by their obstetricians.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949260

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose Carvalho, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00949260     History of Changes
Other Study ID Numbers: 09-01
Study First Received: July 29, 2009
Last Updated: March 25, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
PIH
pregnancy induced hypertension
pregnancy
bioimpedance
 noninvasive monitoring
Cardiac Output
Blood Pressure

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013