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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03095937
Other study ID # ECHO001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2016
Est. completion date December 1, 2018

Study information

Verified date February 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to evaluate fetal myocardial performance in patients with heart diseases in comparison to normal pregnant patients.


Description:

Cardiac diseases affect 1-4% of pregnancies of industrialized countries,and the number of patients who develop cardiac problems during pregnancy is increasing.

Congenital heart diseases, ischemic heart and cardiac arrhythmias are the most dominant causes. In developing countries, rheumatic heart disease remains prevalent. Pregnancy induces haemodynamic changes with increased intravascular volume which may not only poses a risk of maternal death but also of serious morbidity such as heart failure, stroke and cardiac arrhythmia.

The fetus is not spared.Previous reports revealed a significant reduction in fetal growth rates associated with maternal heart disease.There is also association with preterm delivery and reduced birth weight. The presence of maternal cyanosis and a reduced cardiac output are the most significant predictors.

Accurate and reliable measurement of fetal cardiac function could be valuable for making the diagnosis and for fetal surveillanceThe most suitable parameters for assessing fetal cardiac function will mainly be determined by the cause of the dysfunction. Abnormal values of ejection fraction or cardiac output are usually found in the late stages of deterioration, and therefore more sensitive parameters have been proposed for earlier diagnosis and monitoring of fetal cardiac dysfunction. In most cases of cardiac dysfunction, diastolic parameters (such as DV or IRT) are the first to be altered, reflecting impaired relaxation and compliance due to a stiffer or less effective heart. Similarly, parameters reflecting longitudinal function (such as annular displacement or velocities) are typically affected in the early stages as compared to radial function (such as ejection fraction).

The goal of this study is to evaluate fetal myocardial performance in patients with heart diseases in comparison to normal pregnant patients.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date December 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 40 Years
Eligibility Inclusion Criteria:

1. Compensated heart disease.

2. singleton pregnancy

3. Normal placental location

4. Have no associated hypertension, diabetes or any other medical disorders affecting pregnancy

Exclusion Criteria:

The patients have hypertension, diabetes or any other medical disorders affecting pregnancy.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Assiut university Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial performance index Percentage of isovolumetric time to ejection time 30 minutes
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