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

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ClinicalTrials.gov Identifier: NCT00949260
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : March 26, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Hypertension, Pregnancy-Induced

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.


Study Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Assessment of Healthy and Hypertensive Pregnant Women by Non-invasive Bio-reactance
Study Start Date : July 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Cardiac Index (CI) [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. Cardiac Output (CO) [ Time Frame: 20 minutes ]
  2. Blood Pressure (BP) [ Time Frame: 20 minutes ]
  3. Systemic Vascular Resistance (SVR) [ Time Frame: 20 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

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


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

Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00949260     History of Changes
Other Study ID Numbers: 09-01
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: March 26, 2010
Last Verified: March 2010

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