Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAnna Erenbourg
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
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 design
Treatments tested in this trial
- Automated fetal cardiac function evaluation
Treatment groups
495 Participants
are divided into 2 treatment groupsSponsors and collaborators
Anna Erenbourg
Lead sponsor
The University of New South Wales
Sponsor institution
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
Source ClinicalTrials.gov