Pregnancy
Conditions
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
Interventions
OTHERfetal MRI
The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)
Sponsors
LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
University of Paris 5 - Rene Descartes
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of advanced MRI techniques | From inclusion to end of neonatal period (max 25 weeks) | % of satisfactory sequences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of information collected by MRI | From inclusion to end of neonatal period (max 25 weeks) | 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. |
| Acceptability of the examination for the patient: leackertLikert scale | Through MRI study completion an average of 6 months | 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. |
| Reproducibility of the examination analysis | After study completion, an average of one year | will be assessed by means of Kappa coefficient |
| relevance of MRI | From inclusion to end of neonatal period (max 25 weeks) | will be assessed by the % of added informations |
| concordance of information collected by MRI | From inclusion to end of neonatal period (max 25 weeks) | 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. |
| feasibility of fusion imaging (echo / MRI) | After study completion, an average of one year | will be assessed by the success rate of appropriate matching - % of successful echo-IRM fusion |
| norms of growth of main organs and placenta | After study completion, an average of one year | Creating of normal curves by MRI measurements for length at various gestational ages |
| Establishment of an anatomical and functional database on a large group of healthy fetuses | After study completion, an average of one year | 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 |
| Concordance of diagnosis | Termination of pregnancy (max 25 weeks) | Concordance of diagnosis between virtual autopsy and foetopathology |
| Specific Absorption Rate for each type of sequence | After study completion, an average of one year | SAR is an MRI machine parameter |
Countries
France
Contacts
Primary ContactDavid Grevent, MD PHD
Backup ContactAminata TRAORE
Outcome results
None listed