Congenital Heart Defect Clinical Trial
Official title:
Automated Fetal Cardiac Function Parameters in Congenital Heart Disease
NCT number | NCT05698277 |
Other study ID # | 2022/ETH00943 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | February 1, 2028 |
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.
Status | Recruiting |
Enrollment | 495 |
Est. completion date | February 1, 2028 |
Est. primary completion date | January 1, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Hospital for Women | Sydney | New South Wales |
Israel | Sheba Medical Center | Tel Aviv | |
Italy | San Salvatore Hospital L'Aquila | L'Aquila | |
Italy | Vittore Buzzi Children's Hospital | Milan | |
Italy | Institute for Maternal and Child Health IRCCS Burlo Garofolo | Trieste | |
Mayotte | Centre Hospitalier de Mayotte | Mamoudzou | |
Poland | Medical Center Ujastek | Kraków |
Lead Sponsor | Collaborator |
---|---|
Anna Erenbourg | Centre Hospitalier de Mayotte, Clinic of Fetal Echocardiography, Medical Centre UJASTEK, Institute for Maternal and Child Health IRCCS Burlo Garofolo, San Salvatore Hospital of L'Aquila, Sheba Medical Center, Vittore Buzzi Children's Hospital |
Australia, Israel, Italy, Mayotte, Poland,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PWD-MPI to the classical cardiovascular profile score). | Difference in predictive values between Modified and Classical Cardiovascular Profile Score. Minimum score value is 0, Maximum score value is 12. Higher score means a better outcome. | Measurements undertaken within the range 27+6 - 29+6 gestational weeks. | |
Secondary | Predictive value of Modified Cardiovascular Profile Score in hydrops (Adding Automated PWD-MPI to the classical cardiovascular profile score). | Difference in predictive values between Modified and Classical Cardiovascular Profile Score. Minimum score value is 0, Maximum score value is 12. Higher score means a better outcome. | Measurements undertaken within the range 34+6 - 36+6 gestational weeks. | |
Secondary | 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). | Difference in predictive values between Modified and Classical Cardiovascular Profile Score. Minimum score value is 0, Maximum score value is 12. Higher score means a better outcome. | Measurements undertaken within the range 27+6 - 29+6 gestational weeks. | |
Secondary | 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). | Difference in predictive values between Modified and Classical Cardiovascular Profile Score. Minimum score value is 0, Maximum score value is 12. Higher score means a better outcome. | Measurements undertaken within the range 34+6 - 36+6 gestational weeks. | |
Secondary | 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). | Difference in predictive values between Modified and Classical Cardiovascular Profile Score. Minimum score value is 0, Maximum score value is 14. Higher score means a better outcome. | Measurements undertaken within the range 27+6 - 29+6 gestational weeks. | |
Secondary | 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). | Difference in predictive values between Modified and Classical Cardiovascular Profile Score. Minimum score value is 0, Maximum score value is 14. Higher score means a better outcome. | Measurements undertaken within the range 34+6 - 36+6 gestational weeks. |
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