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Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy

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ClinicalTrials.gov Identifier: NCT02643199
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : June 16, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Rehab Mohamed Abdelrahman, Ain Shams University

Study Description
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Brief Summary:
The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.

Condition or disease
Fetal Heart Echocardiography by Five Dimensional Ultrasound

Detailed Description:

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

  1. Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).

  2. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal Heart.

    • 90 consecutive patients will undergo 2D fetal echocardiography by one observer
    • Then they will undergo blindly Five-Dimensional fetal echocardiography by another observer
    • The data collected will be compared to evaluate the accuracy of Five-Dimensional US in fetal heart assessment.
Study Design
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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
Study Start Date : December 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound [ Time Frame: 20 - 36 weeks of gestation ]

    Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:

    1. Four chamber view
    2. Five chamber view
    3. Left outflow tract
    4. Right outflow tract
    5. 3 vessels and Trachea View
    6. Abdomen/Stomach
    7. Ductal arch
    8. aortic arch
    9. Bicaval view then we count howmuch views of nine views were satisfactory


Secondary Outcome Measures :
  1. Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound [ Time Frame: 20 - 36 weeks of gestation ]

    Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:

    1. Four chamber view
    2. Five chamber view
    3. Left outflow tract
    4. Right outflow tract
    5. 3 vessels and Trachea View
    6. Abdomen/Stomach
    7. Ductal arch
    8. aortic arch
    9. Bicaval view then we count howmuch views of nine views were satisfactory


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

Ninety pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

Criteria

Inclusion Criteria:

  1. Singleton pregnancy.
  2. Gestational age at 34-36 weeks as determined be date and last menstrual period.
  3. Normal Amniotic Fluid Index.

Exclusion Criteria:

  1. Multiple pregnancies.
  2. Oligohydramnios or Polyhydramnios (AFI > 95th percentile or < 5th percentile).
  3. Obese patient, BMI > 30
  4. Intrauterine growth restriction.
  5. Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rehab Mohamed Abdelrahman, Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02643199    
Other Study ID Numbers: 5D Echocardiography
First Posted: December 31, 2015    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: July 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy