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

Completed

• Conditions: 10028920; development-of-the-brain; Neurological-development; 10010394; 10010335

• Registration Number: NL-OMON49553
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

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

- 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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Brain age of healthy control fetuses, especially in the third trimester<br /><br>(cortical folding in the brain)<br /><br>2. Speed of maturation of healthy control fetuses, especially in the third<br /><br>trimester</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Brain perfusion of healthy control fetuses<br /><br>2. Growth trajectories of brain structures,<br /><br>3. Brain volume of healthy control fetuses<br /><br>4. Collection of placentas and biomaterial of the umbilical cords for storage<br /><br>for future research. The biomaterials will be stored in the LUMC Biobank<br /><br>Verloskunde. The regulations of the LUMC Biobank Verloskunde will be applicable</p><br>