LUMIERE on the PLACENTA

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04166448
• Other study ID #: APHP190335
• Status: Withdrawn
• Start date: December 2019
• Est. completion date: November 2023

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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)

Locations

Country	Name	City	State
France	Necker - Enfants Malades Hospital	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France, University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Placental response to maternal oxygenation (BOLD)	BOLD effect	From inclusion to end of neonatal period (max 25 weeks)
Secondary	structural changes of the placenta	Diffusion coefficient (ADC)	From inclusion to end of neonatal period (max 25 weeks)
Secondary	structural changes of the placenta	T2 * mapping	From inclusion to end of neonatal period (max 25 weeks)
Secondary	Measurement of placental volume	Placental segmentation	From inclusion to end of neonatal period (max 25 weeks)
Secondary	Measurement of IUGR by fetal segmentation (MRI),	Fetal volume	From inclusion to end of neonatal period (max 25 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	Acceptability of the examination for the patient: questionnaire	Will be assessed by a questionnaire given to pregnant women after the MRI,	at IRM examination
Secondary	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
Secondary	Specific Absorption Rate for each type of sequence	SAR measurement (Specific Absorption Rate)	From inclusion to end of neonatal period (max 25 weeks)