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

NCT04142606 RECRUITING

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	RECRUITING
Enrolment	1500
Start date	2019-12-06
Completion	2027-06

Conditions

• Pregnancy

Interventions

• fetal MRI

Primary outcomes

• feasibility of advanced MRI techniques — From inclusion to end of neonatal period (max 25 weeks)
  % of satisfactory sequences
• feasibility of advanced MRI techniques — From inclusion to end of neonatal period (max 25 weeks)
  quality of standardized morphological fetal examination using recognizable criteria of normality
• feasibility of advanced MRI techniques — From inclusion to end of neonatal period (max 25 weeks)
  quality of standardized functional fetal examination using recognizable criteria of normality

Countries

France