Sief_Twist Sign a Novel View in Fetal Echocardiography

To describe Sief_twist sign as a novel sign in fetal echocardiography as a new ,easy , time effective view in fetal heart examination .

Study Overview

• Status: Completed
• Conditions: Fetal Echocardiography
• Intervention / Treatment: Diagnostic test: Fetal echocardiography

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

observational study conducted at academic perinatal center that investigates Sief_Twest sign as novel sign in fetal heart examination in comparison with classic standard views Patients who give written consent to participate in the study undergo a uniform antenatal assessment protocol that includes basic obstetrics ultrasound examination , fetal anatomy scan & fetal echocardiography .

Description

Inclusion Criteria:

1. Singleton fetus .
2. gestational age 14-37 weeks.
3. no maternal medical disorder .
4. no morbed obisity.

Exclusion Criteria:

1. evidence of fetal infection.
2. chorioamnionitis.
3. fetal anomalies.
4. abnormal fetal karyotype
5. patient withdrawal from the study and/or unavailability for follow-up.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; Extended fetal heart examination	Diagnostic test: Fetal echocardiography; fetal heart examination by medical ultrasound
B; Modified extended heart examination	Diagnostic test: Fetal echocardiography; fetal heart examination by medical ultrasound
C; Sief_Twist sign only examination	Diagnostic test: Fetal echocardiography; fetal heart examination by medical ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
obtaining clear images for fetal cardiac structures via standard views which is 4 chamber view[4CH.], left outflow tract view[LVOT.] , right outflow tract view [RVOT.], three vesseles trachea view [3VTV.]	4 chamber view that describe 4 heart chambers which are 2 atria , 2 ventricles - LVOT. view describes outflow of aorta from left ventricle in normal heart - RVOT describe outflow of pulmonary from rt. ventricle in normal heart - 3VTV describes view of aorta, pulonary and superior viena cava at upper chest	15 miutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): February 4, 2024

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AUE202010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No