PregnancyNCT00522977
Echo-Cardiographic Assessment of Cardiovascular Characteristics During Pregnancy and Postpartum Periods
An observational study of Pregnancy, run by Hillel Yaffe Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy women in first trimester of pregnancy.
Who may be able to join
- Healthy women
- First trimester of a normal pregnancy
- Normal baseline echocardiogram
Who cannot join
- Pregnancy with more than one fetus.
- Any hemodynamically significant cardiac condition
- Any known systemic disease
- Poor quality echocardiogram
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hille Yaffe Medical Center
Hadera, 38100
David S Blondheim, MD, 972-4630-4488, davidb@hy.health.gov.il
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- Myocardial strain, Myocardial function, Pregnancy, Postpartum, Echocardiography, Myocardial adaptation to pregnancy, Systolic function, Diastolic function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startAug 2007
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- David S Blondheim, MD, Principal investigator, Hillel Yaffe Medical CenterAsnat Walfisch, MD, Principal investigator, Hillel Yaffe Medical CenterMordechai Hallak, Prof., Study chair, Hillel Yaffe Medical CenterAvraham Shotan, MD, Study director, Hillel Yaffe Medical CenterKazatzker Mark, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522977
- Sponsor's protocol ID
- BLOND1CTIL
- Status last verified
- Feb 2008
- First submitted
- 29 Aug 2007
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echo-Cardiographic Assessment of Cardiovascular Characteristics During Pregnancy and Postpartum Periods
- ClinicalTrials.gov ID
- NCT00522977
- Acronym / sponsor ID
- BLOND1CTIL
- Conditions
- Pregnancy
- Keywords
- Myocardial strain, Myocardial function, Pregnancy, Postpartum, Echocardiography, Myocardial adaptation to pregnancy, Systolic function, Diastolic function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Aug 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy women in first trimester of pregnancy.
Key inclusion criteria (3 listed)
- Healthy women
- First trimester of a normal pregnancy
- Normal baseline echocardiogram
Key exclusion criteria (4 listed)
- Pregnancy with more than one fetus.
- Any hemodynamically significant cardiac condition
- Any known systemic disease
- Poor quality echocardiogram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Blondheim, MD principal investigator
Hillel Yaffe Medical Center
Asnat Walfisch, MD principal investigator
Hillel Yaffe Medical Center
Mordechai Hallak, Prof. study chair
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David S Blondheim, MD (972-4630-4488, davidb@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2008.