NCT00522977

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

First QC Date

August 29, 2007

Last Update Submit

February 25, 2008

Conditions

Pregnancy

Keywords

Myocardial strainMyocardial functionPregnancyPostpartumEchocardiographyMyocardial adaptation to pregnancySystolic functionDiastolic function

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy women in first trimester of pregnancy.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

Study Officials

  • David S Blondheim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

  • Asnat Walfisch, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

  • Mordechai Hallak, Prof.

    Hillel Yaffe Medical Center

    STUDY CHAIR

  • Avraham Shotan, MD

    Hillel Yaffe Medical Center

    STUDY DIRECTOR

  • Kazatzker Mark, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David S Blondheim, MD

CONTACT

972-4630-4488davidb@hy.health.gov.il

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

August 1, 2007

Study Completion

September 1, 2009

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

IL(1)