NCT04596423

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

October 15, 2020

Last Update Submit

February 17, 2024

Conditions

Outcome Measures

Primary Outcomes (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.]

    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

Study Arms (3)

A

Extended fetal heart examination

Diagnostic Test: Fetal echocardiography

B

Modified extended heart examination

Diagnostic Test: Fetal echocardiography

C

Sief\_Twist sign only examination

Diagnostic Test: Fetal echocardiography

Interventions

Fetal echocardiographyDIAGNOSTIC_TEST

fetal heart examination by medical ultrasound

ABC

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Age GroupsAdult (18-64)
Sampling MethodProbability 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 .

You may qualify if:

  • Singleton fetus .
  • gestational age 14-37 weeks.
  • no maternal medical disorder .
  • no morbed obisity.

You may not qualify if:

  • evidence of fetal infection.
  • chorioamnionitis.
  • fetal anomalies.
  • abnormal fetal karyotype
  • patient withdrawal from the study and/or unavailability for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

January 1, 2020

Primary Completion

October 1, 2023

Study Completion

February 4, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations