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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

Tracking Information
First Submitted Date March 20, 2017
First Posted Date March 30, 2017
Last Update Posted Date March 27, 2018
Actual Study Start Date September 1, 2016
Estimated Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2017)
Myocardial performance index [ Time Frame: 30 minutes ]
Percentage of isovolumetric time to ejection time
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03095937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Fetal Cardiac Function in Rheumatic Heart Disease (RHD) Patients
Official Title Different Modalities for Evaluation of Fetal Cardiac Function in Pregnant Women With Rheumatic Heart Disease (RHD) Patients
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Fetal Distress
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 24, 2017)
152
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2018
Estimated Primary Completion Date September 1, 2018   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sief el eslam Ahmed Ali, master 00201004971596 siefali73@yahoo.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03095937
Other Study ID Numbers ECHO001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sief el eslam Ahmed Ali, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date March 2018