Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

LUMIERE on the PLACENTA (FETUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04166448
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Collaborators:
LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
University of Paris 5 - Rene Descartes
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Pregnancy 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: LUMIERE on the PLACENTA : A Study on the Added Value of MRI
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : November 2023

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)




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


Secondary Outcome Measures :
  1. Placental response to maternal oxygenation (BOLD) [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    BOLD effect

  2. structural changes of the placenta [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    Diffusion coefficient (ADC)

  3. structural changes of the placenta [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    T2 * mapping

  4. Measurement of placental volume [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    Placental segmentation

  5. Measurement of IUGR by fetal segmentation (MRI), [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    Fetal volume

  6. evaluation of brain resonance [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    BOLD effect, - ADC coefficient and IVIM parameters by variation of T2 * relaxation time

  7. evaluation of kidney resonance [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    BOLD effect, - ADC coefficient and IVIM parameters by variation of T2 * relaxation time

  8. evaluation of liver resonance [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    BOLD effect, - ADC coefficient and IVIM parameters by variation of T2 * relaxation time

  9. Reproducibility of the examination analysis [ Time Frame: After study completion, an average of one year ]
    Correlations between microcirculatory parameters in utero, fetal weight at MRI and birth weight

  10. Uterine arteries [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    Measurement of blood flow in the uterine arteries by MRI 4D FLOW (in development) and Doppler (US) (feasibility study)

  11. Acceptability of the examination for the patient: questionnaire [ Time Frame: at IRM examination ]
    Will be assessed by a questionnaire given to pregnant women after the MRI,

  12. Acceptability of the examination for the patient: Likert scale [ Time Frame: at IRM examination ]
    will be assessed once by a Likert scale: 4 points Likert (poor, average, good, very good)

  13. Specific Absorption Rate for each type of sequence [ Time Frame: From inclusion to end of neonatal period (max 25 weeks) ]
    SAR measurement (Specific Absorption Rate)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166448


Contacts
Layout table for location contacts
Contact: David Grevent, PH 0144841734 david.grevent@gmail.com
Contact: Nelly Briand, PhD 01 44 38 18 62 nelly.briand@aphp.fr

Locations
Layout table for location information
France
Necker - Enfants Malades Hospital
Paris, France, 75015
Contact: Laurent Salomon, MD, PhD    0144496481    laurentsalomon@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France
University of Paris 5 - Rene Descartes
Investigators
Layout table for investigator information
Principal Investigator: Laurent Salomon, MD, PhD Principal Investigator
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04166448    
Other Study ID Numbers: APHP190335
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No