PregnancyNCT04166448
LUMIERE on the PLACENTA
An observational study of Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Fetal MRI
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2019to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant patients with low and high risk of placental IUGR followed in the Fetal Medicine Department of the Necker-Enfants Malades hospital.
Who may be able to join
- 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
Who cannot join
- - Contraindication to MRI
- Impossible subsequent follow up
- Maternal status contraindicates continuation of pregnancy
- Participation in another search
- "Protected" patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Fetal MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal MRIOther
The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus(es)
| Study group | Role | What they receive |
|---|---|---|
| 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), Receives: 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) Receives: Other: Fetal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From inclusion to end of neonatal period (max 25 weeks)
Secondary outcomes (13)
Placental response to maternal oxygenation (BOLD)
BOLD effect
Measured: From inclusion to end of neonatal period (max 25 weeks)
structural changes of the placenta
Diffusion coefficient (ADC)
Measured: From inclusion to end of neonatal period (max 25 weeks)
structural changes of the placenta
T2 * mapping
Measured: From inclusion to end of neonatal period (max 25 weeks)
Measurement of placental volume
Placental segmentation
Measured: From inclusion to end of neonatal period (max 25 weeks)
Measurement of IUGR by fetal segmentation (MRI),
Fetal volume
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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,
Measured: 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)
Measured: at IRM examination
Specific Absorption Rate for each type of sequence
SAR measurement (Specific Absorption Rate)
Measured: From inclusion to end of neonatal period (max 25 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study startDec 2019 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: Never start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France, University of Paris 5 - Rene Descartes, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laurent Salomon, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166448
- Sponsor's protocol ID
- APHP190335
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUMIERE on the PLACENTA : A Study on the Added Value of MRI
- ClinicalTrials.gov ID
- NCT04166448
- Acronym / sponsor ID
- APHP190335
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France, University of Paris 5 - Rene Descartes, URC-CIC Paris Descartes Necker Cochin
- Study start
- Dec 2019 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: High risk IUGR patients | – | Other: Fetal MRIEPF<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 | – | Other: Fetal MRIEPF et PA>20th perc (reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients with low and high risk of placental IUGR followed in the Fetal Medicine Department of the Necker-Enfants Malades hospital.
Key inclusion criteria (5 listed)
- Singleton pregnancy without fetal malformation seen on ultrasound. Group 1: High risk IUGR patients
- Group 2: Low risk IUGR patients
- EPF et PA>20th perc reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW
Key exclusion criteria (5 listed)
- - Contraindication to MRI
- Impossible subsequent follow up
- Maternal status contraindicates continuation of pregnancy
- Participation in another search
- "Protected" patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal MRIThe MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus(es) | Other | Group 1: High risk IUGR patients, Group 2: Low risk IUGR patients |
Primary outcome
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)
13 secondary outcomes
Placental response to maternal oxygenation (BOLD)
Time frame: From inclusion to end of neonatal period (max 25 weeks)
structural changes of the placenta
Time frame: From inclusion to end of neonatal period (max 25 weeks)
structural changes of the placenta
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Measurement of placental volume
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Measurement of IUGR by fetal segmentation (MRI),
Time frame: From inclusion to end of neonatal period (max 25 weeks)
evaluation of brain resonance
Time frame: From inclusion to end of neonatal period (max 25 weeks)
evaluation of kidney resonance
Time frame: From inclusion to end of neonatal period (max 25 weeks)
evaluation of liver resonance
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Reproducibility of the examination analysis
Time frame: After study completion, an average of one year
Uterine arteries
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Acceptability of the examination for the patient: questionnaire
Time frame: at IRM examination
Acceptability of the examination for the patient: Likert scale
Time frame: at IRM examination
Specific Absorption Rate for each type of sequence
Time frame: From inclusion to end of neonatal period (max 25 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Salomon, MD, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in placental blood flow as seen in vascular IUGR (time frame: From inclusion to end of neonatal period (max 25 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.