Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
ID05698277

Automated Fetal Cardiac Function Parameters in Congenital Heart Disease An International Observational Study

Led by Anna Erenbourg · Updated on 2024-12-10

495

Participants Needed

7

Research Sites

4 weeks

Total Duration

On this page

Sponsors

A

Anna Erenbourg

Lead Sponsor

C

Centre Hospitalier de Mayotte

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying automated fetal heart function parameters to see if they differ between healthy babies and those with congenital heart disease. This international multicenter observational study aims to find out if these automated measurements can better predict heart complications like hydrops compared to current cardiovascular scores. The study focuses on pregnancies with and without fetal heart defects to compare cardiac function over time. Participants will have two fetal cardiac function ultrasound scans: one between 27 weeks and 29 weeks plus 6 days of pregnancy, and another between 34 weeks and 36 weeks plus 6 days. These scans use both clinical and advanced research ultrasound systems to capture detailed heart measurements, including heart size, valve function, blood flow, and contractility. The study collects images and data securely and follows participants until delivery and hospital discharge. During the study, women will undergo standard pregnancy ultrasounds alongside research scans assessing various heart function parameters. Researchers will analyze these detailed images and functional data to compare healthy and affected fetuses. They will also evaluate if adding automated measures improves prediction of complications like hydrops. Data confidentiality is maintained, and results will be published while protecting patient privacy. The entire pregnancy period is observed, with data collected at two specific gestational windows.

CONDITIONS

Brief Title

Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants
  • Singleton pregnancies
  • Gestational age between 19 weeks + 6 days and 36 weeks + 6 days, confirmed by ultrasound
  • For CHD Group: isolated congenital cardiac anomaly diagnosed
  • For Control Group: no congenital cardiac anomaly diagnosed
Not Eligible

You will not qualify if you...

  • Mothers with comorbidities affecting fetal heart function such as intrahepatic cholestasis, pre-gestational or gestational diabetes, and preeclampsia
  • Fetuses with growth restriction defined as estimated fetal weight or abdominal circumference below the 3rd percentile for gestational age
  • Fetuses with other structural extracardiac anomalies
  • Fetuses with any diagnosed genetic abnormalities
  • Multiple pregnancies (non-singleton)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 8 weeks (from approximately 19 weeks + 6 days to 27 weeks + 6 days of gestation)

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Diagnostic Evaluation

Duration - From 27 weeks + 6 days to 36 weeks + 6 days of gestation

Participants undergo fetal cardiac function echocardiography to evaluate automated ultrasound parameters including cardiac morphology and function at two specified gestational age windows.

2 visits (in-person) between 27+6 - 29+6 weeks and 34+6 - 36+6 weeks gestation

Long-term Monitoring

Duration - Until delivery and hospital discharge

Participants are followed up until delivery and discharge of mother and neonate to collect pregnancy and birth outcomes information.

Follow-up through standard prenatal and postnatal care visits; visit schedule varies

Trial Site Locations

Total: 7 locations

1

Royal Hospital for Women

Sydney, New South Wales, Australia

Actively Recruiting

2

Sheba Medical Center

Tel Aviv, Israel

Not Yet Recruiting

3

San Salvatore Hospital L'Aquila

L’Aquila, Italy

Not Yet Recruiting

4

Vittore Buzzi Children's Hospital

Milan, Italy

Not Yet Recruiting

5

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Italy

Not Yet Recruiting

6

Centre Hospitalier de Mayotte

Mamoudzou, Mayotte

Not Yet Recruiting

7

Medical Center Ujastek

Krakow, Poland

Not Yet Recruiting

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Research Team

A

Anna Erenbourg, MD

A

Alec W Welsh, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Comprehensive Functional Echocardiographic Assessment of Transposition of the Great Arteries: From Fetus to Newborn.

Carin Walter, Iris Soveral, Joaquim Bartrons...

https://pubmed.ncbi.nlm.nih.gov/31919591

Left ventricular myocardial performance in the fetus with severe tricuspid valve disease and tricuspid insufficiency.

Noboru Inamura, Mio Taketazu, Jeffrey F Smallhorn...

https://pubmed.ncbi.nlm.nih.gov/15731988

Tissue Doppler imaging in fetuses with aortic stenosis and evolving hypoplastic left heart syndrome before and after fetal aortic valvuloplasty.

C Wohlmuth, D Wertaschnigg, I Wieser...

https://pubmed.ncbi.nlm.nih.gov/25914144

Right Ventricular Systolic-to-Diastolic Time Index: Hypoplastic Left Heart Fetuses Differ Significantly from Normal Fetuses.

Hythem M Nawaytou, Shabnam Peyvandi, Michael M Brook...

https://pubmed.ncbi.nlm.nih.gov/26394829