Sief_Twist Sign a Novel View in Fetal Echocardiography

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04596423
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 26.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fetal Echocardiography	Diagnostic Test: Fetal echocardiography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Sief_Twist Sign a Novel View in Fetal Echocardiography
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.] [15 miutes]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assuit		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sief el eslam Ahmed Ali, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04596423
• Other Study ID Numbers: AUE202010
• First Posted: Oct 22, 2020
• Last Update Posted: Oct 23, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 23, 2020