LUMIERE on the FETUS

Last updated: December 26, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

fetal MRI

Clinical Study ID

NCT04142606
APHP190334
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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-upof her pregnancy (identified or strongly suspected echocardiographic abnormality onultrasound, diaphragmatic dome hernia, CMV fetal infection, antecedent brainabnormality in siblings, STT operated)

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: fetal MRI
Phase:
Study Start date:
December 06, 2019
Estimated Completion Date:
June 30, 2027

Study 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

Connect with a study center

  • Necker - Enfants Malades Hospital

    Paris, 75015
    France

    Active - Recruiting

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