Advanced Fetal MRI techniques: assessment of fetal cardiovascular anatomy disturbances in children with congenital heart disease

Conditions: Complex congenital heart disease
10007510

Registration Number: NL-OMON56891

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 159

Inclusion Criteria

Antenatal diagnosis of significant aortic and/or pulmonary CHD, defined as
requiring intervention within the first year of postnatal life.
Informed consent provided by both parents.
Gestational age >24 weeks. The optimal gestational age for fetal CMR currently
lies between 30-34 weeks.

Exclusion Criteria

Maternal age <16 years
Inability to correctly inform parents about study due to language barrier or
other factors
Contraindication to MRI (see Radiology department checklist)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To test feasibility of fetal CMR on the three available MRI vendors (Philips,<br /><br>Siemens, General Electric) in all academic centers in The Netherlands.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess diagnostic capacity of fetal CMR and the additive value to fetal<br /><br>echocardiography (at gestational age 20-24 weeks and 30-34 weeks) for correct<br /><br>antenatal diagnosis of significant aortic and/or pulmonary CHD (correct CHD<br /><br>diagnosis based on postnatal findings).</p><br>