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

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ClinicalTrials.gov Identifier: NCT00522977
Recruitment Status : Unknown
Verified February 2008 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
First Posted : August 30, 2007
Last Update Posted : February 29, 2008
Information provided by:

Study Description
Brief Summary:

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 or disease

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.

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Time Perspective: Prospective
Study Start Date : August 2007
Estimated Study Completion Date : September 2009
Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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.

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

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

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
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 Posted: August 30, 2007    Key Record Dates
Last Update Posted: February 29, 2008
Last Verified: February 2008

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