Evaluation of Fetal Cardiac Function in Rheumatic Heart Disease (RHD) Patients

NCT ID: NCT03095937

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-12-01

Brief Summary

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

Detailed 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.

Conditions

Fetal Distress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sief el eslam Ahmed Ali

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

ECHO001

Identifier Type: -

Identifier Source: org_study_id