About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

intrahepatic cholestasis

pre-gestational and gestational diabetes

preeclampsia

growth restricted fetuses defined as estimated fetal weight or abdominal circumference <3rd percentile for GA

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

495 Participants

are divided into 2 treatment groups

Group A: Cases1 intervention

Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

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

2

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.

Time frame

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

3

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.

Time frame

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

4

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.

Time frame

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

Secondary outcomes

1

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.

Time frame

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

2

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.

Time frame

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

3

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.

Time frame

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

4

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.

Time frame

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