NCT05090306

Brief Summary

The study to be performed aims to design and develope an automated Intelligent Decision Support System for fetal echocardiography that can significantly assist the obstetric physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.

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 Nov 2020

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

October 22, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

October 11, 2021

Last Update Submit

October 11, 2021

Conditions

Congenital Heart Disease

Keywords

Artificial intelligenceFetal cardiologyEchocardiographyDecision support systems

Outcome Measures

Primary Outcomes (1)

  • Development of an Intelligent Decision Support System for fetal echocardiography

    The primary objective of this study is the design and development of the IS that can significantly assist the physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.

    24 months

Secondary Outcomes (2)

  • Counseling aid for newly trained sonographers

    36 months

  • Improveing the prenatal diagnosis

    36 months

Study Arms (1)

Pregnant women in their first and second trimester

Pregnant women in their first and second trimester will be examined using two-dimensional echocardiography of the fetal heart.

Diagnostic Test: Routine ultrasound examination

Interventions

Routine ultrasound examinationDIAGNOSTIC_TEST

ULTRASOUND EXAMINATION Women recruited to take part in the study will undergo the routine ultrasound examinations and monitoring, including a fetal echocardiogram between 12-13+6 weeks of gestation (for the first trimester cases) and between 18-24 weeks of gestation (for the second trimester cases). Two-dimensional evaluation of each fetal heart will include a cine loop sweep obtained from the from the four-chamber view plane by moving the transducer cranially towards the upper mediastinum, allowing the visualization of the following planes: four-chamber view, left and right ventricular outflow tracts, three vessels and trachea view. The examination will be stored for further analysis.

Pregnant women in their first and second trimester

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All pregnant women of 18 years and above, in their first and second trimester are considered eligible for the study.

You may qualify if:

  • pregnant women in their first and second trimester
  • signed informed consent for the study

You may not qualify if:

  • unknown outcome of pregnancy
  • age under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Emergency County Hospital

Craiova, Dolj, Romania

RECRUITING

Related Publications (1)

  • Ungureanu A, Marcu AS, Patru CL, Ruican D, Nagy R, Stoean R, Stoean C, Iliescu DG. Learning deep architectures for the interpretation of first-trimester fetal echocardiography (LIFE) - a study protocol for developing an automated intelligent decision support system for early fetal echocardiography. BMC Pregnancy Childbirth. 2023 Jan 11;23(1):20. doi: 10.1186/s12884-022-05204-x.

    PMID: 36631859DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Dominic G Iliescu, Assoc. Prof.

    University of Medicine and Pharmacy Craiova

    STUDY CHAIR

  • Anda Ungureanu, PhD(c)

    University of Medicine and Pharmacy Craiova

    STUDY DIRECTOR

  • Rodica Nagy, PhD(c)

    University of Medicine and Pharmacy Craiova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic G Iliescu, Assoc. Prof.

CONTACT

723888773dominic.iliescu@yahoo.com

Rodica D Nagy, PhD(c)

CONTACT

769658773rodica.nagy25@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

November 1, 2020

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

October 22, 2021

Record last verified: 2021-08

Locations

RO(1)