Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
Key facts
- Who runs it
- Anna Erenbourg
- Where
- L’Aquila, Milan, and Trieste, ItalySee the 3 sitesAlso in 4 other countries, 4 sites
- Trial code
- Status
- Recruiting
- People taking part
- 495 people, planned
- Started
- 1 May 2023
- Expected to end
- 1 Feb 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Automated fetal cardiac function evaluation
- Record updated
- 10 December 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 4 other countries, 4 sites
- San Salvatore Hospital L'AquilaL’Aquila, ItalyContact: Ilaria FantasiaNot yet recruiting
- Vittore Buzzi Children's HospitalMilan, ItalyContact: Stefano FaiolaNot yet recruiting
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"Trieste, ItalyContact: Tamara StampalijaNot yet recruiting
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Cases
Singleton pregnancies affected by congenital heart disease
Treatment: Automated fetal cardiac function evaluation
- Controls
Singleton healthy pregnancies
Treatment: Automated fetal cardiac function evaluation
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Automated Fetal Cardiac Function Parameters in Congenital Heart Disease
- Record updated
- 10 December 2024