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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643199
First Posted: December 31, 2015
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rehab Mohamed Abdelrahman, Ain Shams University
  Purpose
The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the fetal heart from 20-36 weeks of gestation.

Condition
Fetal Heart Echocardiography by Five Dimensional Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy

Resource links provided by NLM:


Further study details as provided by Rehab Mohamed Abdelrahman, Ain Shams University:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 90
Study Start Date: December 2015
Study Completion Date: September 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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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
No Contacts or Locations Provided
  More Information

Responsible Party: Rehab Mohamed Abdelrahman, Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02643199     History of Changes
Other Study ID Numbers: 5D Echocardiography
First Submitted: December 28, 2015
First Posted: December 31, 2015
Results First Submitted: April 4, 2017
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