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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05698277




Registration number
NCT05698277
Ethics application status
Date submitted
18/12/2022
Date registered
26/01/2023

Titles & IDs
Public title
Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
Scientific title
Automated Fetal Cardiac Function Parameters in Congenital Heart Disease
Secondary ID [1] 0 0
2022/ETH00943
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Defect 0 0
Cardiac Function 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Automated fetal cardiac function evaluation

Cases - Singleton pregnancies affected by congenital heart disease

Controls - Singleton healthy pregnancies


Diagnosis / Prognosis: Automated fetal cardiac function evaluation
Evaluation of ultrasound parameters by automated algorithms.

Ultrasound assessed parameters are:

1. Pulsed wave Doppler Modified Left and Right Myocardial performance indices
2. Spatio-temporal image correlation Tricuspid, Mitral and Septal Annular Plane Systolic Excursion
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Automated PWD-MPI comparing fetuses affected by congenital heart disease (CHD) to reference values across the fetal healthy population.
Timepoint [1] 0 0
Measurements undertaken within the range 27+6 - 29+6 gestational weeks
Primary outcome [2] 0 0
Automated STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion comparing fetuses affected by congenital heart disease to reference values across the fetal healthy population.
Timepoint [2] 0 0
Measurements undertaken within the range 27+6 - 29+6 gestational weeks
Primary outcome [3] 0 0
Automated PWD-MPI comparing fetuses affected by congenital heart disease (CHD) to reference values across the fetal healthy population.
Timepoint [3] 0 0
Measurements undertaken within the range 34+6 - 36+6 gestational weeks
Primary outcome [4] 0 0
Automated STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion comparing fetuses affected by congenital heart disease to reference values across the fetal healthy population.
Timepoint [4] 0 0
Measurements undertaken within the range 34+6 - 36+6 gestational weeks
Primary outcome [5] 0 0
Automated PWD-MPI comparing fetuses affected by congenital heart disease (CHD) to reference values across the fetal healthy population.
Timepoint [5] 0 0
Measurements undertaken within the range 27+6 - 29+6 gestational weeks and within the range 34+6 - 36+6 gestational weeks
Primary outcome [6] 0 0
Automated STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion comparing fetuses affected by congenital heart disease (CHD) to reference values across the fetal healthy population.
Timepoint [6] 0 0
Measurements undertaken within the range 27+6 - 29+6 gestational weeks and within the range 34+6 - 36+6 gestational weeks
Secondary outcome [1] 0 0
Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PWD-MPI to the classical cardiovascular profile score).
Timepoint [1] 0 0
Measurements undertaken within the range 27+6 - 29+6 gestational weeks.
Secondary outcome [2] 0 0
Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PWD-MPI to the classical cardiovascular profile score).
Timepoint [2] 0 0
Measurements undertaken within the range 34+6 - 36+6 gestational weeks.
Secondary outcome [3] 0 0
Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion to the classical cardiovascular profile score).
Timepoint [3] 0 0
Measurements undertaken within the range 27+6 - 29+6 gestational weeks.
Secondary outcome [4] 0 0
Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion to the classical cardiovascular profile score).
Timepoint [4] 0 0
Measurements undertaken within the range 34+6 - 36+6 gestational weeks.
Secondary outcome [5] 0 0
Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PW-MPI and STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion to the classical cardiovascular profile score).
Timepoint [5] 0 0
Measurements undertaken within the range 27+6 - 29+6 gestational weeks.
Secondary outcome [6] 0 0
Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PW-MPI and STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion to the classical cardiovascular profile score).
Timepoint [6] 0 0
Measurements undertaken within the range 34+6 - 36+6 gestational weeks.

Eligibility
Key inclusion criteria
* Inclusion criteria for the CHD Group are as follows: singleton pregnancies; gestational age between 19+6 and 36+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; isolated congenital cardiac anomaly diagnosed.
* Inclusion criteria for the Control Group are as follows: singleton pregnancies; gestational age between 19+6 and 27+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; no congenital cardiac anomaly diagnosed
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria common to the 2 groups (Cases and Controls):

* Fetuses whose mothers have comorbidities that have been proven to potentially affect cardiac function including:

* intrahepatic cholestasis
* pre-gestational and gestational diabetes
* preeclampsia
* growth restricted fetuses defined as estimated fetal weight or abdominal circumference <3rd percentile for GA
* Fetuses with other structural extracardiac anomalies at ultrasound examination
* Fetuses affected by any diagnosed genetic abnormalities

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
495
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Hospital for Women - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Tel Aviv
Country [2] 0 0
Italy
State/province [2] 0 0
L'Aquila
Country [3] 0 0
Italy
State/province [3] 0 0
Milan
Country [4] 0 0
Italy
State/province [4] 0 0
Trieste
Country [5] 0 0
Mayotte
State/province [5] 0 0
Mamoudzou
Country [6] 0 0
Poland
State/province [6] 0 0
Kraków

Funding & Sponsors
Primary sponsor type
Other
Name
Anna Erenbourg
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Centre Hospitalier de Mayotte
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Vittore Buzzi Children's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
San Salvatore Hospital of L'Aquila
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Sheba Medical Center
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Clinic of Fetal Echocardiography, Medical Centre UJASTEK
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anna Erenbourg, MD
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anna Erenbourg, MD
Address 0 0
Country 0 0
Phone 0 0
+61423879866
Fax 0 0
Email 0 0
a.erenbourg@unsw.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Participant Data (IPD) that underlie results will be shared with other researchers in a publication.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Data will become available from 6 months after publication.
Available to whom?
Data will be accessible online on request by researchers. Requests will be reviewed and evaluated by the Principal Investigator. Data will be available for meta-analyses involving the collection, checking, and re-analysis of the original data for each participant in each study.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05698277