LUMIERE on the FETUS

NCT04142606 | Recruiting

• 1 other identifier: APHP190334
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Congenital anomalies are a major public health problem. They affect 2-3% of births, around 20,000 new cases per year in France, of which 15% are cared for in Ile de France. These congenital anomalies are a major cause of morbidity, infant mortality and disability. They are also a major cause of death during the infant period (22% of deaths during the first year of life: source CépiDC Inserm 2010). The detection, accurate diagnosis and accurate prognosis, particularly functional, of these congenital anomalies are still difficult in the current monitoring of pregnancy, which is based primarily on ultrasound. The use and development of modern imaging techniques is now essential to enable doctors to better see and better examine the fetus. Alongside ultrasound, Magnetic Resonance Imaging (MRI) is a technique that has undergone significant development in recent years. MRI must allow the effective anatomical and functional evaluation of the main fetal organs and could in particular be interesting in several situations in which it has not yet been sufficiently evaluated and is not yet performed in clinical routine.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (3)

• feasibility of advanced MRI techniques

  % of satisfactory sequences

  From inclusion to end of neonatal period (max 25 weeks)

• feasibility of advanced MRI techniques

  quality of standardized morphological fetal examination using recognizable criteria of normality

  From inclusion to end of neonatal period (max 25 weeks)

• feasibility of advanced MRI techniques

  quality of standardized functional fetal examination using recognizable criteria of normality

  From inclusion to end of neonatal period (max 25 weeks)

Secondary Outcomes (19)

• concordance of information collected by MRI

  From inclusion to end of neonatal period (max 25 weeks)

• concordance of information collected by MRI

  From inclusion to end of neonatal period (max 25 weeks)

• Concordance of information collected by MRI

  From inclusion to end of neonatal period (max 25 weeks)

• Acceptability of the examination for the patient: leackertLikert scale

  Through MRI study completion an average of 6 months

• Reproducibility of the examination analysis

  After study completion, an average of one year

Study Arms (4)

Control Group (Group 1)

Having prenatal ultrasound screening without detected abnormality

Other: fetal MRI

Non Optimal Ultrasound Scan Group (Group 2)

Having an ultrasound examination without abnormality detected but in whom ultrasound examination is not optimal (poor technical conditions, multiple pregnancies, obese patients)

Other: fetal MRI

Malformation Group (Group 3)

Standardized prenatal screening with ultrasound examination finding an isolated anomaly that does not currently constitute a commonly accepted indication of fetal MRI

Other: fetal MRI

TOP Group (Group 4)

A medical termination of pregnancy, (TOP), in addition to a fetopathological examination (virtopsy)

Other: fetal MRI

Interventions

fetal MRI OTHER

The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)

Control Group (Group 1); Malformation Group (Group 3); Non Optimal Ultrasound Scan Group (Group 2); TOP Group (Group 4)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients followed in the Fetal Medicine Department of the Necker-Enfants Malades hospital belonging to one of the following 4 groups: * Having prenatal ultrasound screening without detected abnormality * Having an ultrasound examination without abnormality detected but in whom ultrasound examination is not optimal (poor technical conditions, multiple pregnancies, obese patients) * Standardized prenatal screening with ultrasound examination finding an isolated anomaly that does not currently constitute a commonly accepted indication of fetal MRI * A medical termination of pregnancy, in addition to a fetopathological examination (virtopsy)

You may qualify if:

• patient ≥ 18 years
• Single or twin pregnancy
• gestational age≥ 16 WG and ≤ 36 WG based on cranio-caudal length (LCC) dating
• Collection of the patient's consent

You may not qualify if:

• contraindication to MRI
• multiple pregnancies \> 2
• subsequent follow-up impossible
• maternal condition contraindicates continuation of pregnancy
• patient having to have an MRI examination as part of the normal clinical follow-up of her pregnancy (identified or strongly suspected echocardiographic abnormality on ultrasound, diaphragmatic dome hernia, CMV fetal infection, antecedent brain abnormality in siblings, STT operated)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker - Enfants Malades Hospital

Paris, 75015, France

RECRUITING

Related Publications (2)

• Bouachba A, Bartin R, De Jesus Neves J, Bussieres L, Grevent D, Virfollet J, Gauchard G, Bobet L, Roux N, Glemain B, Salomon LJ, Gorincour G. Normative range of MRI-based fetal body volume and association with ultrasonographically estimated fetal weight at 16-36 weeks: prospective study. Ultrasound Obstet Gynecol. 2025 Jul;66(1):81-88. doi: 10.1002/uog.29234. Epub 2025 May 26.

  PMID: 40418192 DERIVED

• Bartin R, Melbourne A, Bobet L, Gauchard G, Menneglier A, Grevent D, Bussieres L, Siauve N, Salomon LJ. Static and dynamic responses to hyperoxia of normal placenta across gestation with T2*-weighted MRI sequences. Ultrasound Obstet Gynecol. 2024 Aug;64(2):236-244. doi: 10.1002/uog.27609.

  PMID: 38348601 DERIVED

Study Officials

• Laurent Salomon, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Grevent, MD PHD

CONTACT

+ 33144841734; david.grevent@gmail.com

Aminata TRAORE

CONTACT

+ 331 48 19 27 34; aminata.traore6@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: October 29, 2019
• Study Start: December 6, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)