Placental InsufficiencyNCT01092949
Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
An observational study of Placental Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placental Insufficiency
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Sep 2018
- 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: All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.
Who may be able to join
- Women > 18 years,
- Undergoing TOP for fetal reason,
- Informed signed consent.
Who cannot join
- Placental adhesion anomaly,
- Growth restriction,
- Contrast agent allergy,
- Absent consent,
- Contraindication of MRI or Gadolinium,
- Renal insufficiency,
- Placental abnormality at pathological examination.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.
Read the detailed description
Objective:
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.
Method:
All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.
120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG.
MRI will be performed in the same hospital, during hospital stay, within 45 minutes.
Two MRI sequences will be used to measure placental perfusion:
- dynamic sequences using Gd contrast agent.
- " spin tagging ", which do not need any contrast agent. Perfusion will be modelled using compartmental analysis. Reference ranges will be build up by statistical modelling. Gadolinium assays will be performed on amniotic fluid and placental tissue following TOP.
Duration of inclusion: 24 months.
Duration of patient participation: 45 minutes.
Expected results:
- Feasibility in routine practice.
- Reference ranges for placental perfusion.
- Comparison between the two measurements methods.
Adverse outcome measure:
Nausea, vomiting, lack of comfort and other adverse outcome.
- Conditions
- Placental Insufficiency
- Being tested
- MRI
- Keywords
- Placenta, perfusion, MRI, spin tagging, Gadolinium, placental insufficiency, urinary tract, sexual organs and pregnancy conditions
- Medical subject headings
- Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called MRI, 45 minutes
MRI, 45 minutes
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of physiological reference range of placental perfusion
Establishment of physiological reference range of placental perfusion
Measured: 45 MIN
Secondary outcomes (2)
To quantify in vivo and by a not invasive way the microscopic physiological phenomena relative to the placental perfusion and in the local transcapillary exchanges of the placenta
Measured: 45 MIN
Comparison between the two measurements methods.
Measured: 45 MIN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Placental InsufficiencyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laurent Salomon, MCU PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092949
- Sponsor's protocol ID
- P 081111
- Other IDs
- 2009-A01024-63
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2010
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Deloison B, Arthuis C, Benchimol G, Balvay D, Bussieres L, Millischer AE, Grevent D, Butor C, Chalouhi G, Mahallati H, Helenon O, Tavitian B, Clement O, Ville Y, Siauve N, Salomon LJ. Human placental perfusion measured using dynamic contrast enhancement MRI. PLoS One. 2021 Sep 2;16(9):e0256769. doi: 10.1371/journal.pone.0256769. eCollection 2021.
PubMed 34473740Siauve N, Hayot PH, Deloison B, Chalouhi GE, Alison M, Balvay D, Bussieres L, Clement O, Salomon LJ. Assessment of human placental perfusion by intravoxel incoherent motion MR imaging. J Matern Fetal Neonatal Med. 2019 Jan;32(2):293-300. doi: 10.1080/14767058.2017.1378334. Epub 2017 Oct 3.
PubMed 28974131
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
- ClinicalTrials.gov ID
- NCT01092949
- Acronym / sponsor ID
- P 081111
- Conditions
- Placental Insufficiency
- Keywords
- Placenta, perfusion, MRI, spin tagging, Gadolinium, placental insufficiency, urinary tract, sexual organs and pregnancy conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Feb 2010 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 25 Mar 2010 (estimated)
- 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.
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.
Detailed description
Objective:
To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.
Method:
All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.
120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG.
MRI will be performed in the same hospital, during hospital stay, within 45 minutes.
Two MRI sequences will be used to measure placental perfusion:
- dynamic sequences using Gd contrast agent.
- " spin tagging ", which do not need any contrast agent. Perfusion will be modelled using compartmental analysis. Reference ranges will be build up by statistical modelling. Gadolinium assays will be performed on amniotic fluid and placental tissue following TOP.
Duration of inclusion: 24 months.
Duration of patient participation: 45 minutes.
Expected results:
- Feasibility in routine practice.
- Reference ranges for placental perfusion.
- Comparison between the two measurements methods.
Adverse outcome measure:
Nausea, vomiting, lack of comfort and other adverse outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.
Key inclusion criteria (3 listed)
- Women > 18 years,
- Undergoing TOP for fetal reason,
- Informed signed consent.
Key exclusion criteria (7 listed)
- Placental adhesion anomaly,
- Growth restriction,
- Contrast agent allergy,
- Absent consent,
- Contraindication of MRI or Gadolinium,
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 |
|---|---|---|
| MRIAlso: MRI, 45 minutesMRI, 45 minutes | Device | – |
Primary outcome
Establishment of physiological reference range of placental perfusion
Time frame: 45 MIN
Establishment of physiological reference range of placental perfusion
2 secondary outcomes
To quantify in vivo and by a not invasive way the microscopic physiological phenomena relative to the placental perfusion and in the local transcapillary exchanges of the placenta
Time frame: 45 MIN
Comparison between the two measurements methods.
Time frame: 45 MIN
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 34473740Deloison B, Arthuis C, Benchimol G, Balvay D, Bussieres L, Millischer AE, Grevent D, Butor C, Chalouhi G, Mahallati H, Helenon O, Tavitian B, Clement O, Ville Y, Siauve N, Salomon LJ. Human placental perfusion measured using dynamic contrast enhancement MRI. PLoS One. 2021 Sep 2;16(9):e0256769. doi: 10.1371/journal.pone.0256769. eCollection 2021.
- Results publication: PubMed 28974131Siauve N, Hayot PH, Deloison B, Chalouhi GE, Alison M, Balvay D, Bussieres L, Clement O, Salomon LJ. Assessment of human placental perfusion by intravoxel incoherent motion MR imaging. J Matern Fetal Neonatal Med. 2019 Jan;32(2):293-300. doi: 10.1080/14767058.2017.1378334. Epub 2017 Oct 3.
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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, MCU PH principal investigator
Assistance Publique - Hôpitaux de Paris
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 Placental Insufficiency, 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 10 Mar 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Establishment of physiological reference range of placental perfusion (time frame: 45 MIN). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01092949, which also lists 2 linked publications.
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 10 Mar 2026.