NCT05698277 Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
| NCT ID | NCT05698277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anna Erenbourg |
| Condition | Congenital Heart Defect |
| Study Type | OBSERVATIONAL |
| Enrollment | 495 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 495 participants in total. It began in 2023-05-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Anna Erenbourg, MD
PRINCIPAL INVESTIGATOR
The University of New South Wales
Frequently Asked Questions
Who can join the NCT05698277 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Congenital Heart Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05698277 currently recruiting?
Yes, NCT05698277 is actively recruiting participants. Contact the research team at a.erenbourg@unsw.edu.au for enrollment information.
Where is the NCT05698277 trial being conducted?
This trial is being conducted at Sydney, Australia, Tel Aviv, Israel, L’Aquila, Italy, Milan, Italy and 3 additional locations.
Who is sponsoring the NCT05698277 clinical trial?
NCT05698277 is sponsored by Anna Erenbourg. The principal investigator is Anna Erenbourg, MD at The University of New South Wales. The trial plans to enroll 495 participants.