An observational study in Pregnancy, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant patients followed in the Fetal Medicine Department of the Necker-Enfants Malades hospital belonging to one of the following 4 groups:
Exclusion Criteria:
contraindication to MRI
Having prenatal ultrasound screening without detected abnormality
Other: fetal MRI
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
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
A medical termination of pregnancy, (TOP), in addition to a fetopathological examination (virtopsy)
Other: fetal MRI
The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)
feasibility of advanced MRI techniques
% of satisfactory sequences
Time frame: 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
Time frame: 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
Time frame: 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 of usual appearance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through MRI study completion an average of 6 months
Reproducibility of the examination analysis
will be assessed by means of Kappa coefficient
Time frame: After study completion, an average of one year
relevance of MRI
will be assessed by the % of added informations
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Specific Absorption Rate for each type of sequence
SAR is an MRI machine parameter
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After study completion, an average of one year
Concordance of diagnosis
Concordance of diagnosis between virtual autopsy and foetopathology
Time frame: Termination of pregnancy (max 25 weeks)
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris