LUMIERE on the PLACENTA

LUMIERE on the PLACENTA : A Study on the Added Value of MRI

The frequency of IUGR is between 3 and 10% of births. The etiologies and mechanisms of IUGR are multiple. The placental insufficiency, that is the defect of perfusion, is, however, the principal mechanism, far in front of other maternal or fetal causes. This placental insufficiency is also now recognized as an essential risk factor for cardiovascular and metabolic diseases, such as diabetes, in adulthood. The interest in understanding in utero development is thus further increased by the short-, medium- and long-term consequences of placental dysfunction. However, there are few ways to evaluate uteroplacental vascularization in vivo. MRI is an imaging technique used routinely in the exploration of the fetus in addition to ultrasound. Its safety on the fetus and the mother is largely demonstrated at 1.5T. There are also MRI sequences used daily in the clinic to evaluate perfusion and organ structure in children and adults (brain, kidney, heart, etc.). Their application for evaluation of perfusion and placental structure, although still confined to research, is very promising. The investigator's team has extensive experience, in animals or in children, in the use of these sequences that could be used to evaluate placental function in vivo. The ASL (Arterial Spin Labeling) in particular is the most encouraging functional imaging technique because it allows today to measure an organ blood flow quantitatively and without injection of contrast medium.

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy
• Intervention / Treatment: Other: Fetal MRI

Detailed Description

The inclusion will take place at the earliest at 20 weeks after the completion of the standard morphological ultrasound of the 2nd trimester (carried out at 20-24SA) and at the latest at 35 SA, within the framework of one of the 2 clinical subgroups of patients considered (high risk and low risk).

The objectives of this study will be achieved by the prospective setting up of a LUMIERE cohort on PLACENTA.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker - Enfants Malades Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients with low and high risk of placental IUGR followed in the Fetal Medicine Department of the Necker-Enfants Malades hospital.

Description

Inclusion Criteria:

• Singleton pregnancy without fetal malformation seen on ultrasound. Group 1: High risk IUGR patients

  • EPF<10th perc or PA<10th perc and Doppler ombilical IP> 95th percentile,
  • EPF or PA<3th perc reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW,

Group 2: Low risk IUGR patients

• EPF et PA>20th perc reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW

Exclusion Criteria:

• - Contraindication to MRI
• Impossible subsequent follow up
• Maternal status contraindicates continuation of pregnancy
• Participation in another search
• "Protected" patient

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1: High risk IUGR patients; EPF<10th perc or PA<10th perc and Doppler ombilical IP> 95th percentile, EPF or PA<3th perc (reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW),	Other: Fetal MRI; The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus(es)
Group 2: Low risk IUGR patients; EPF et PA>20th perc (reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW)	Other: Fetal MRI; The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus(es)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in placental blood flow as seen in vascular IUGR	25% reduction in overall placental perfusion measured ASL with IUGR (defined as <3th perc birth weight) versus controls (birth weight> 10th perc)	From inclusion to end of neonatal period (max 25 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental response to maternal oxygenation (BOLD)	BOLD effect	From inclusion to end of neonatal period (max 25 weeks)
structural changes of the placenta	Diffusion coefficient (ADC)	From inclusion to end of neonatal period (max 25 weeks)
structural changes of the placenta	T2 * mapping	From inclusion to end of neonatal period (max 25 weeks)
Measurement of placental volume	Placental segmentation	From inclusion to end of neonatal period (max 25 weeks)
Measurement of IUGR by fetal segmentation (MRI),	Fetal volume	From inclusion to end of neonatal period (max 25 weeks)
evaluation of brain resonance	BOLD effect, - ADC coefficient and IVIM parameters by variation of T2 * relaxation time	From inclusion to end of neonatal period (max 25 weeks)
evaluation of kidney resonance	BOLD effect, - ADC coefficient and IVIM parameters by variation of T2 * relaxation time	From inclusion to end of neonatal period (max 25 weeks)
evaluation of liver resonance	BOLD effect, - ADC coefficient and IVIM parameters by variation of T2 * relaxation time	From inclusion to end of neonatal period (max 25 weeks)
Reproducibility of the examination analysis	Correlations between microcirculatory parameters in utero, fetal weight at MRI and birth weight	After study completion, an average of one year
Uterine arteries	Measurement of blood flow in the uterine arteries by MRI 4D FLOW (in development) and Doppler (US) (feasibility study)	From inclusion to end of neonatal period (max 25 weeks)
Acceptability of the examination for the patient: questionnaire	Will be assessed by a questionnaire given to pregnant women after the MRI,	at IRM examination
Acceptability of the examination for the patient: Likert scale	will be assessed once by a Likert scale: 4 points Likert (poor, average, good, very good)	at IRM examination
Specific Absorption Rate for each type of sequence	SAR measurement (Specific Absorption Rate)	From inclusion to end of neonatal period (max 25 weeks)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University of Paris 5 - Rene Descartes; URC-CIC Paris Descartes Necker Cochin; LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
• Investigators: Principal Investigator: Laurent Salomon, MD, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2019
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: APHP190335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No