Clinical trial NCT04142606: LUMIERE on the FETUS
Official title: LUMIERE on the FETUS : a Study on the Added Value of Fetal MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
name: University of Paris 5 - Rene Descartes
First posted: 2019-10-29
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Detailed description: 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

Eligibility criteria: 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)

Primary outcomes:
measure: feasibility of advanced MRI techniques
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: feasibility of advanced MRI techniques
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: feasibility of advanced MRI techniques
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
Secondary outcomes:
measure: concordance of information collected by MRI
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: concordance of information collected by MRI
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: Concordance of information collected by MRI
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: Acceptability of the examination for the patient: leackertLikert scale
timeFrame: Through MRI study completion an average of 6 months
measure: Reproducibility of the examination analysis
timeFrame: After study completion, an average of one year
measure: relevance of MRI
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: Specific Absorption Rate for each type of sequence
timeFrame: After study completion, an average of one year
measure: feasibility of fusion imaging (echo / MRI)
timeFrame: After study completion, an average of one year
measure: norms of growth of main organs and placenta
timeFrame: After study completion, an average of one year
measure: norms of growth of main organs and placenta
timeFrame: After study completion, an average of one year
measure: norms of growth of main organs and placenta
timeFrame: After study completion, an average of one year
measure: norms of growth of main organs and placenta
timeFrame: After study completion, an average of one year
measure: Establishment of an anatomical and functional database on a large group of healthy fetuses
timeFrame: After study completion, an average of one year
measure: Establishment of an anatomical and functional database on a large group of healthy fetuses
timeFrame: After study completion, an average of one year
measure: Establishment of an anatomical and functional database on a large group of healthy fetuses
timeFrame: After study completion, an average of one year
measure: Establishment of an anatomical and functional database on a large group of healthy fetuses
timeFrame: After study completion, an average of one year
measure: Establishment of an anatomical and functional database on a large group of healthy fetuses
timeFrame: After study completion, an average of one year
measure: Establishment of an anatomical and functional database on a large group of healthy fetuses
timeFrame: After study completion, an average of one year
measure: Concordance of diagnosis
timeFrame: Termination of pregnancy (max 25 weeks)
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker - Enfants Malades Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent Salomon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: