LUMIERE on the FETUS

Study Overview
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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

Official Title
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LUMIERE on the FETUS : A Study on the Added Value of Fetal MRI

Conditions
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Pregnancy

Intervention / Treatment
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* Other: fetal MRI


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group (Group 1)<br>Having prenatal ultrasound screening without detected abnormality | Other: fetal MRI<br>* The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)<br>|
| Non Optimal Ultrasound Scan Group (Group 2)<br>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<br>* The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)<br>|
| Malformation Group (Group 3)<br>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<br>* The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)<br>|
| TOP Group (Group 4)<br>A medical termination of pregnancy, (TOP), in addition to a fetopathological examination (virtopsy) | Other: fetal MRI<br>* The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance of information collected by MRI | Concordance of the diagnosis carried out on each standardized section in ultrasound, MRI and the final diagnosis: Standardized cuts with main anatomical landmarks seen and of usual appearance. | From inclusion to end of neonatal period (max 25 weeks) | 
| concordance of information collected by MRI | Concordance of the diagnosis carried out on each standardized section in ultrasound, MRI and the final diagnosis: Standardized cuts with main anatomical landmarks seen and unusual appearance. | From inclusion to end of neonatal period (max 25 weeks) | 
| Concordance of information collected by MRI | Concordance of the diagnosis carried out on each standardized section in ultrasound, MRI and the final diagnosis: Standardized cuts with main non-evaluable anatomical landmarks. | From inclusion to end of neonatal period (max 25 weeks) | 
| Acceptability of the examination for the patient: leackertLikert scale | will be assessed by a Likert scale. which is a psychometric tool for measuring an attitude in individuals. It consists of one or more statements (statements or items) for which the respondent expresses her degree of agreement or disagreement (5 items from 1 to 5 points : from very poor, poor, average, good, very good). A scale of several items can be summarized by the average of the item scores. | Through MRI study completion an average of 6 months | 
| Reproducibility of the examination analysis | will be assessed by means of Kappa coefficient | After study completion, an average of one year | 
| relevance of MRI | will be assessed by the % of added informations | From inclusion to end of neonatal period (max 25 weeks) | 
| Specific Absorption Rate for each type of sequence | SAR is an MRI machine parameter | After study completion, an average of one year | 
| feasibility of fusion imaging (echo / MRI) | will be assessed by the success rate of appropriate matching - % of successful echo-IRM fusion | After study completion, an average of one year | 
| norms of growth of main organs and placenta | Creating of normal curves by MRI measurements for length at various gestational ages | After study completion, an average of one year | 
| norms of growth of main organs and placenta | Creating of normal curves by MRI measurements: for width at various gestational ages | After study completion, an average of one year | 
| norms of growth of main organs and placenta | Creating of normal curves by MRI measurements for height at various gestational ages | After study completion, an average of one year | 
| norms of growth of main organs and placenta | Creating of normal curves by MRI measurements for volumes at various gestational ages | After study completion, an average of one year | 
| Establishment of an anatomical and functional database on a large group of healthy fetuses | Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal brain acquired thought gestation and anatomical and using functionnal sequences | After study completion, an average of one year | 
| Establishment of an anatomical and functional database on a large group of healthy fetuses | Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal thorax acquired thought gestation and anatomical and using functionnal sequences | After study completion, an average of one year | 
| Establishment of an anatomical and functional database on a large group of healthy fetuses | Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal heart acquired thought gestation and anatomical and using functionnal sequences | After study completion, an average of one year | 
| Establishment of an anatomical and functional database on a large group of healthy fetuses | Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal abdomen acquired thought gestation and anatomical and using functionnal sequences | After study completion, an average of one year | 
| Establishment of an anatomical and functional database on a large group of healthy fetuses | Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of fetal limb acquired thought gestation and anatomical and using functionnal sequences | After study completion, an average of one year | 
| Establishment of an anatomical and functional database on a large group of healthy fetuses | Build up of normal atlas of MRI images in normal fetuses. We will stored anonymous images of placenta acquired thought gestation and anatomical and using functionnal sequences | After study completion, an average of one year | 
| Concordance of diagnosis | Concordance of diagnosis between virtual autopsy and foetopathology | Termination of pregnancy (max 25 weeks) |