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Clinical Trials/NCT02643199
NCT02643199
Completed
Not Applicable

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

Ain Shams University0 sites90 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetal Heart Echocardiography by Five Dimensional Ultrasound
Sponsor
Ain Shams University
Enrollment
90
Primary Endpoint
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
September 2016
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rehab Mohamed Abdelrahman

Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University

Ain Shams University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Multiple pregnancies.
  • Oligohydramnios or Polyhydramnios (AFI \> 95th percentile or \< 5th percentile).
  • Obese patient, BMI \> 30
  • Intrauterine growth restriction.
  • Fetal spine between the 11- and 1- O'clock positions due to possibility of shadowing from ribs or spine

Outcomes

Primary Outcomes

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 Outcomes

  • Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound(20 - 36 weeks of gestation)

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