NCT04897178

Brief Summary

MARS is an artificial intelligence-powered system that aims at detecting common fetal anomalies during real-time obstetrics ultrasound. The current study comprises 2 stages: (1) The stage of model creation which will include retrospective collection of images from fetal anatomy scans with known diagnoses to train these model and test their diagnostic accuracy. (2) The stage of model validation through prospective application of this model to collected videos with known normal and abnormal diagnoses

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

May 18, 2021

Last Update Submit

May 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Diagnostic accuracy of deep learning models in identifying major fetal structural anomalies

    Fetuses between 10 weeks and 32 weeks of gestation

Study Arms (2)

Fetuses with normal anatomy

Fetuses with normal anatomy scan who demonstrate no structural abnormalities of different systems (CNS, chest and heart, abdomen, skeletal system)

Diagnostic Test: Ultrasound

Fetuses with abnormal anatomy

Fetuses with abnormal anatomy scan who demonstrate any structural abnormalities that can be detected with ultrasound

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Routine 2 dimensional Ultrasound used to screen fetuses for congenital anomalies

Fetuses with abnormal anatomyFetuses with normal anatomy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women who underwent fetal mid-trimester anatomy scan (between 18 and 22 weeks) with or without first trimester fetal anatomy scan (11-14 weeks) with documented ultrasound results and recorded images with are consistent with postnatal diagnosis

You may qualify if:

  • Pregnant women between 18 and 45 years
  • Available ultrasound image with clear findings
  • postnatal confirmation of diagnosis

You may not qualify if:

  • Absence of research authorization on medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aswan Faculty of Medicine

Aswān, 81528, Egypt

Location

Assiut Faculty of Medicine - Women Health Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 21, 2021

Study Start

June 1, 2021

Primary Completion

May 1, 2022

Study Completion

December 1, 2023

Last Updated

May 25, 2021

Record last verified: 2021-05

Locations