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LUMIERE on the FETUS

NCT ID: NCT04142606

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-06

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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The inclusion will take place from 16WF to 36WG, within the framework of one of the 4 clinical subgroups of patients envisaged.

The standardized anatomic and functional MRI examination will in all cases last less than 45 minutes and will be based on sequences already used in clinical practice.

Clinical, biological, and ultrasound data will be collected prospectively and used for the usual management of the patient. For the purposes of the study, these data will be secondarily anonymized and analyzed in connection with the MRI data and the perinatal outcome to meet the specific objectives.

The lost-to-follow-up bias will be limited by the simplicity of the proposed perinatal surveillance, which does not differ from the surveillance usually recommended for these pregnancies

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group (Group 1)

Having prenatal ultrasound screening without detected abnormality

fetal MRI

Intervention Type OTHER

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

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)

fetal MRI

Intervention Type OTHER

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

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

fetal MRI

Intervention Type OTHER

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

TOP Group (Group 4)

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

fetal MRI

Intervention Type OTHER

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

Interventions

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fetal MRI

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France

UNKNOWN

Sponsor Role collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Salomon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Necker - Enfants Malades Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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David Grevent, MD PHD

Role: CONTACT

Phone: + 33144841734

Email: [email protected]

Aminata TRAORE

Role: CONTACT

Phone: + 331 48 19 27 34

Email: [email protected]

Facility Contacts

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Laurent Salomon, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40418192 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38348601 (View on PubMed)

Other Identifiers

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APHP190334

Identifier Type: -

Identifier Source: org_study_id