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Automated Fetal Cardiac Function in Babies Affected by Heart Diseases

RECRUITINGSponsored by Anna Erenbourg
Actively Recruiting
SponsorAnna Erenbourg
Started2023-05-01
Est. completion2028-01-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions3

Cardiac FunctionCongenital Heart DefectHeart Disease

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