LUMIERE on the PLACENTA

NCT04166448 | Withdrawn

• 1 other identifier: APHP190335
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Placental response to maternal oxygenation (BOLD)

  From inclusion to end of neonatal period (max 25 weeks)

• structural changes of the placenta

  From inclusion to end of neonatal period (max 25 weeks)

• structural changes of the placenta

  From inclusion to end of neonatal period (max 25 weeks)

• Measurement of placental volume

  From inclusion to end of neonatal period (max 25 weeks)

• Measurement of IUGR by fetal segmentation (MRI),

  From inclusion to end of neonatal period (max 25 weeks)

Study Arms (2)

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

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

Interventions

Fetal MRI OTHER

The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus(es)

Group 1: High risk IUGR patients; Group 2: Low risk IUGR patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker - Enfants Malades Hospital

Paris, 75015, France

Location

Study Officials

• Laurent Salomon, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: November 18, 2019
• Study Start: December 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)