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

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ClinicalTrials.gov Identifier: NCT03095937
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sief el eslam Ahmed Ali, 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.

Condition or disease
Fetal Distress

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.


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Study Type : Observational
Estimated Enrollment : 152 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Different Modalities for Evaluation of Fetal Cardiac Function in Pregnant Women With Rheumatic Heart Disease (RHD) Patients
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. Myocardial performance index [ Time Frame: 30 minutes ]
    Percentage of isovolumetric time to ejection time



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Pregnant women with compensated rheumatic heart disease and pregnant women with normal pregnancy with the same inclusion/exclusion criteria listed below.

Inclusion criteria:

  1. Age of the patient: 15-40 years old.
  2. Compensated rheumatic heart disease.
  3. singleton Singleton pregnancy.
  4. Normal placental location.

Exclusion criteria:

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095937


Contacts
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Contact: Sief el eslam Ahmed Ali, master 00201004971596 siefali73@yahoo.com

Locations
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Egypt
Assiut university Recruiting
Assuit, Egypt
Contact: sief eleslam Ahmed Ali    00201004971596    siefali73@yahoo.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Sief el eslam Ahmed Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03095937     History of Changes
Other Study ID Numbers: ECHO001
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Rheumatic Heart Disease
Fetal Distress
Cardiovascular Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Signs and Symptoms