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

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound	Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views: Four chamber view; Five chamber view; Left outflow tract; Right outflow tract; 3 vessels and Trachea View; Abdomen/Stomach; Ductal arch; aortic arch; Bicaval view then we count howmuch views of nine views were satisfactory	20 - 36 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound	Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views: Four chamber view; Five chamber view; Left outflow tract; Right outflow tract; 3 vessels and Trachea View; Abdomen/Stomach; Ductal arch; aortic arch; Bicaval view then we count howmuch views of nine views were satisfactory	20 - 36 weeks of gestation

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 5D Echocardiography

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy