Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

NCT05698277 | Recruiting DMC

• 1 other identifier: 2022/ETH00943
• Study Type: observational
• Target: 495
• Locations: 5 countries
• Sites: 7

Brief Summary

The goal of this international multicentre prospective observational cohort study with a nested case-control study is to test some automated fetal heart functional parameters in healthy babies compared to those affected by a congenital heart condition. The main questions it aims to answer are:

• If there is a significant difference between the two populations of infants
• Whether these parameters could significantly improve the predictive value of actual cardiovascular profile score to predict hydrops Participants will be offered two automated cardiac function assessments between 27+6 and 29+6 gestational weeks and between 34+6 and 36+6 weeks of gestation. Functional parameters will be compared between the two study groups and evaluated over time.

Conditions

Congenital Heart Defect; Cardiac Function

Keywords

Congenital Heart Diseases; Fetal Cardiac Function

Outcome Measures

Primary Outcomes (6)

• Automated PWD-MPI comparing fetuses affected by congenital heart disease (CHD) to reference values across the fetal healthy population.

  Measure the difference in the mean absolute numerical value for PWD-MPI (expressed to 2 decimal places) between fetuses with CHD overall compared to healthy fetuses and then by subgroups of different CHDs.

  Measurements undertaken within the range 27+6 - 29+6 gestational weeks

• 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.

  Difference in absolute values for each of STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion between fetuses with CHD overall compared to healthy fetuses and then by subgroups of different CHDs.

  Measurements undertaken within the range 27+6 - 29+6 gestational weeks

• Automated PWD-MPI comparing fetuses affected by congenital heart disease (CHD) to reference values across the fetal healthy population.

  Measure the difference in the mean absolute numerical value for PWD-MPI (expressed to 2 decimal places) between fetuses with CHD overall compared to healthy fetuses and then by subgroups of different CHDs.

  Measurements undertaken within the range 34+6 - 36+6 gestational weeks

• 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.

  Difference in absolute values for each of STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion between fetuses with CHD overall compared to healthy fetuses and then by subgroups of different CHDs.

  Measurements undertaken within the range 34+6 - 36+6 gestational weeks

• Automated PWD-MPI comparing fetuses affected by congenital heart disease (CHD) to reference values across the fetal healthy population.

  Difference in variation of the mean absolute value for PWD-MPI over time between fetuses with CHD overall compared to healthy fetuses and then by subgroups of different CHDs.

  Measurements undertaken within the range 27+6 - 29+6 gestational weeks and within the range 34+6 - 36+6 gestational weeks

• 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.

  Difference in variation of absolute values for each of STIC Tricuspid, Mitral and Septal Annular Plane Systolic Excursion between fetuses with CHD overall compared to healthy fetuses and then by subgroups of different CHDs.

  Measurements undertaken within the range 27+6 - 29+6 gestational weeks and within the range 34+6 - 36+6 gestational weeks

Secondary Outcomes (6)

• Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PWD-MPI to the classical cardiovascular profile score).

  Measurements undertaken within the range 27+6 - 29+6 gestational weeks.

• Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PWD-MPI to the classical cardiovascular profile score).

  Measurements undertaken within the range 34+6 - 36+6 gestational weeks.

• 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).

  Measurements undertaken within the range 27+6 - 29+6 gestational weeks.

• 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).

  Measurements undertaken within the range 34+6 - 36+6 gestational weeks.

• 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).

  Measurements undertaken within the range 27+6 - 29+6 gestational weeks.

Study Arms (2)

Cases

Singleton pregnancies affected by congenital heart disease

Diagnostic Test: Automated fetal cardiac function evaluation

Controls

Singleton healthy pregnancies

Diagnostic Test: Automated fetal cardiac function evaluation

Interventions

Automated fetal cardiac function evaluation DIAGNOSTIC_TEST

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

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women will be recruited from each participating centre during their second or third trimester morphology scan. The Control Group will be mostly recruited at the time of the second trimester morphology scan; the CHD Group during a second/third trimester anomaly scan with collaboration and referral from the hospital fetal cardiologist. Healthy patients will be approached in the waiting room after their second trimester ultrasound scan, offered to participate and given a copy of a patient information sheet and consent form. CHD patients will be approached and offered to participate after consultation with perinatal cardiologists. A week after the first contact, we will phone patients to verify their intention to take part and to organize the fetal cardiac function follow up.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Erenbourg: lead
• Centre Hospitalier de Mayotte: collaborator
• Vittore Buzzi Children's Hospital: collaborator
• San Salvatore Hospital of L'Aquila: collaborator
• Institute for Maternal and Child Health IRCCS Burlo Garofolo: collaborator
• Sheba Medical Center: collaborator
• Clinic of Fetal Echocardiography, Medical Centre UJASTEK: collaborator

Study Sites (7)

Royal Hospital for Women

Sydney, New South Wales, Australia

RECRUITING

Sheba Medical Center

Tel Aviv, Israel

NOT YET RECRUITING

San Salvatore Hospital L'Aquila

L’Aquila, Italy

NOT YET RECRUITING

Vittore Buzzi Children's Hospital

Milan, Italy

NOT YET RECRUITING

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Italy

NOT YET RECRUITING

Centre Hospitalier de Mayotte

Mamoudzou, Mayotte

NOT YET RECRUITING

Medical Center Ujastek

Krakow, Poland

NOT YET RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anna Erenbourg, MD

  The University of New South Wales

  PRINCIPAL INVESTIGATOR

• Alec W Welsh, MD PhD

  The University of New South Wales

  STUDY DIRECTOR

Central Study Contacts

Anna Erenbourg, MD

CONTACT

+61423879866; a.erenbourg@unsw.edu.au

Alec W Welsh, MD PhD

CONTACT

alec.welsh@unsw.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Obstetrics and Gynaecology

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: January 26, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available from 6 months after publication.
• Access Criteria: 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.

Locations

AU (1); IT (3); PL (1); IL (1); MA (1)