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Normal fetal neurodevelopment: healthy control population to compare with fetuses with a congenital heart disease

Normal fetal neurodevelopment: healthy control population to compare with fetuses with a congenital heart disease - FEND

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49553
Enrollment
70
Registered
2020-07-27
Start date
2020-10-22
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

development-of-the-brain Neurological-development

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Singleton pregnancy - Normal second trimester ultrasound (absence of abnormalities on ultrasound) - No use of alcohol, drugs or other psychoactive substances during pregnancy - Age >= 18 years - Gestational age 18-36 weeks

Exclusion criteria

Exclusion criteria: - Obstetric history of intra-uterine growth restriction or intra-uterine fetal demise - Serious underlying maternal medical condition - Use of teratogenic medication during pregnancy - Congenital abnormalities detected in the first year of life

Design outcomes

Primary

MeasureTime frame
1. Brain age of healthy control fetuses, especially in the third trimester (cortical folding in the brain) 2. Speed of maturation of healthy control fetuses, especially in the third trimester

Secondary

MeasureTime frame
1. Brain perfusion of healthy control fetuses 2. Growth trajectories of brain structures, 3. Brain volume of healthy control fetuses 4. Collection of placentas and biomaterial of the umbilical cords for storage for future research. The biomaterials will be stored in the LUMC Biobank Verloskunde. The regulations of the LUMC Biobank Verloskunde will be applicable

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)