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

Completed

• Conditions: Fetal Distress

• Registration Number: NCT03095937
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-24
• Study First Posted: 2017-03-30
• Primary Completion: 2018-09-01
• Study Completion: 2018-12-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-15
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial performance index	30 minutes	Percentage of isovolumetric time to ejection time

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assuit, Egypt