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

Fetal Distress Clinical Trial

— RHD  

Official title:

Different Modalities for Evaluation of Fetal Cardiac Function in Pregnant Women With Rheumatic Heart Disease (RHD) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095937
• Other study ID #: ECHO001
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Fetal Distress
• Heart Diseases
• Rheumatic Heart Disease

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