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Echo-Cardiographic Assessment of Cardiovascular Characteristics During Pregnancy and Postpartum Periods

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522977
First Posted: August 30, 2007
Last Update Posted: February 29, 2008
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.
Information provided by:
Hillel Yaffe Medical Center
  Purpose

The purpose of this echocardiographic study is to restudy the longitudinal changes in cardiac size and function during and after pregnancy in healthy women using relatively new parameters of systolic and diastolic function as well as classical measures of left ventricle (LV) function using contemporary echocardiographic machines.

We, the researchers at Hillel Yaffe Medical Center, will assess diastolic function and its possible relation to shortness of breath.


Condition
Pregnancy

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment: 400
Study Start Date: August 2007
Estimated Study Completion Date: September 2009
Detailed Description:

A comprehensive echocardiographic study of the heart will be conducted in the first, second and third trimesters of pregnancy and 3 months postpartum.

Determination of left ventricular dimensions, transvalvular Doppler flow, ejection fraction, stroke volume, cardiac output, pulmonary vein flow, tissue Doppler, flow propagation, global and segmental strain parameters, timing of peak strain and various parameters of diastolic function will be obtained.

From these data normal values for various stages of pregnancy will be determined as well as range for changes expected during longitudinal follow-up will be determined.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy women in first trimester of pregnancy.
Criteria

Inclusion Criteria:

  • Healthy women
  • First trimester of a normal pregnancy
  • Normal baseline echocardiogram

Exclusion Criteria:

  • Pregnancy with more than one fetus.
  • Any hemodynamically significant cardiac condition
  • Any known systemic disease
  • Poor quality echocardiogram
  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): NCT00522977


Contacts
Contact: David S Blondheim, MD 972-4630-4488 davidb@hy.health.gov.il

Locations
Israel
Hille Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: David S Blondheim, MD    972-4630-4488    davidb@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: David S Blondheim, MD Hillel Yaffe Medical Center
Principal Investigator: Asnat Walfisch, MD Hillel Yaffe Medical Center
Study Chair: Mordechai Hallak, Prof. Hillel Yaffe Medical Center
Study Director: Avraham Shotan, MD Hillel Yaffe Medical Center
Principal Investigator: Kazatzker Mark, MD Hillel Yaffe Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00522977     History of Changes
Other Study ID Numbers: BLOND1CTIL
First Submitted: August 29, 2007
First Posted: August 30, 2007
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by Hillel Yaffe Medical Center:
Myocardial strain
Myocardial function
Pregnancy
Postpartum
Echocardiography
Myocardial adaptation to pregnancy
Systolic function
Diastolic function