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

Completed

• Conditions: Fetal Heart Echocardiography by Five Dimensional Ultrasound

• Registration Number: NCT02643199
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-31
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Results First Submitted: 2017-04-04
• Results First Submitted QC: 2017-04-04
• Status Verified: 2017-06
• Results First Posted: 2017-06-16
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound	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

Name	Time	Method
Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound	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