Actively Recruiting

Age: 20Weeks - 37Weeks
All Genders
Healthy Volunteers
ID06081036

Normative Brain Volume Profiles From Multicenter Fetal MRI Scans to Assess Prenatal Development

Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-06-11

1423

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying fetal brain development by creating normal brain volume curves using MRI scans taken during pregnancy. These curves aim to help doctors better understand and diagnose abnormalities detected by routine ultrasound. The project collects brain MRI scans from four French hospitals and follows up with families to assess their children's development after birth. This observational study focuses on brain tissue volume evolution and aims to improve diagnosis through quantitative brain measurements. The study uses fetal MRIs without abnormalities collected at partner hospitals in Marseille, Nice, Montpellier, and Paris. Families of children who had these scans more than three years ago will be contacted to complete questionnaires about their children's development. The project applies specialized analysis methods developed by the laboratory to establish normative brain volume curves. There is no treatment or intervention beyond observational data collection and questionnaires. Participants will provide information through questionnaires evaluating child development after birth. Researchers will analyze the MRI scans and compare brain volume curves with existing literature to validate their findings. They will also study how different MRI scanners might affect the results. The primary outcome is to determine normative brain volume curves, with follow-up averaging three years. Participation involves data collection and follow-up questionnaires but no direct medical procedures or treatments.

CONDITIONS

Brief Title

Normative Brain Volume Profiles From Multicenter Fetal MRI

Who Can Participate

Age: 20Weeks - 37Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child who had a cerebral MRI during the fetal period more than 3 years ago at one of the 4 partner centers
Not Eligible

You will not qualify if you...

  • Child with commissural malformation (corpus callosum anomaly)
  • Child with genetic syndrome, chromosomal abnormality, or harmful mutation
  • Child with syndromic extra-cerebral malformations including heart defects
  • Child with intrauterine growth restriction reported in obstetrical records
  • Child with confirmed maternal-fetal infection (TORCH, parvovirus, or other)
  • Multiple pregnancy (twins or more)
  • Mother treated for diabetes during pregnancy, including gestational diabetes
  • Mother treated with antiepileptic medication during pregnancy
  • Alcohol or drug use during pregnancy
  • Presence of a sustentorial arachnoid cyst
  • Presence of an arachnoid cyst causing mass effect
  • Objection from parental authority holders to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 years

Participants undergo review of prior fetal MRI scans and complete a questionnaire about child development.

1 initial visit and periodic questionnaire assessments

Long-term Monitoring

Duration - Up to 3 years

Participants are observed over time to determine normative brain volume curves and assess developmental outcomes.

Periodic assessments over study duration

Trial Site Locations

Total: 1 location

1

CHU Timone

Marseille, France, 13005

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Research Team

N

Nadine Girard, Pr

A

Aurélie Ponz

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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