Clinical trial NCT04166448: LUMIERE on the PLACENTA
Official title: LUMIERE on the PLACENTA : A Study on the Added Value of MRI
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
name: University of Paris 5 - Rene Descartes
First posted: 2019-11-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in placental blood flow as seen in vascular IUGR
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
Secondary outcomes:
measure: Placental response to maternal oxygenation (BOLD)
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: structural changes of the placenta
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: structural changes of the placenta
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: Measurement of placental volume
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: Measurement of IUGR by fetal segmentation (MRI),
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: evaluation of brain resonance
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: evaluation of kidney resonance
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: evaluation of liver resonance
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: Reproducibility of the examination analysis
timeFrame: After study completion, an average of one year
measure: Uterine arteries
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
measure: Acceptability of the examination for the patient: questionnaire
timeFrame: at IRM examination
measure: Acceptability of the examination for the patient: Likert scale
timeFrame: at IRM examination
measure: Specific Absorption Rate for each type of sequence
timeFrame: From inclusion to end of neonatal period (max 25 weeks)
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker - Enfants Malades Hospital
Study officials:
affiliation: Principal Investigator
name: Laurent Salomon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: