Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
This trial has no sites in United States.
It has sites in 5 countries. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Anna Erenbourg
- Trial code
- NCT05698277
- Record updated
- 10 December 2024
- Original description
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.Read full original descriptionShow less
Automated Fetal Cardiac Function Parameters in Congenital Heart Disease
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.
Inclusion: 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: 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.