LUMIERE on the FETUS

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Pregnancy

Treatments: Other: fetal MRI

Study type: Observational

Funder types: Other

Identifiers

NCT04142606

APHP190334

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,200 participants in 4 patient groups

Control Group (Group 1)

Description:

Having prenatal ultrasound screening without detected abnormality

Treatment:

Other: fetal MRI

Non Optimal Ultrasound Scan Group (Group 2)

Description:

Having an ultrasound examination without abnormality detected but in whom ultrasound examination is not optimal (poor technical conditions, multiple pregnancies, obese patients)

Treatment:

Other: fetal MRI

Malformation Group (Group 3)

Description:

Standardized prenatal screening with ultrasound examination finding an isolated anomaly that does not currently constitute a commonly accepted indication of fetal MRI

Treatment:

Other: fetal MRI

TOP Group (Group 4)

Description:

A medical termination of pregnancy, (TOP), in addition to a fetopathological examination (virtopsy)

Treatment:

Other: fetal MRI