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NCT00522977 Clinical Trial

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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00522977
Other study ID # BLOND1CTIL
Secondary ID
Status Recruiting
Phase N/A
First received August 29, 2007
Last updated February 25, 2008
Start date August 2007
Est. completion date September 2009

Study information
Verified date February 2008
Source Hillel Yaffe Medical Center
Contact David S Blondheim, MD
Phone 972-4630-4488
Email davidb@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date September 2009
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Hille Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

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