Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
2 other identifiers
observational
135
1 country
1
Brief 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 referral center.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedMarch 10, 2026
March 1, 2026
8.1 years
February 26, 2010
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establishment of physiological reference range of placental perfusion
Establishment of physiological reference range of placental perfusion
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
45 MIN
Comparison between the two measurements methods.
45 MIN
Interventions
Eligibility Criteria
All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.
You may qualify if:
- Women \> 18 years,
- Undergoing TOP for fetal reason,
- Informed signed consent.
You may not qualify if:
- Placental adhesion anomaly,
- Growth restriction,
- Contrast agent allergy,
- Absent consent,
- Contraindication of MRI or Gadolinium,
- Renal insufficiency,
- Placental abnormality at pathological examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necker Enfants Malades
Paris, 75015, France
Related Publications (2)
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.
PMID: 34473740RESULTSiauve 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.
PMID: 28974131RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Salomon, MCU PH
Assistance Publique Hopitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2010
First Posted
March 25, 2010
Study Start
February 1, 2010
Primary Completion
March 1, 2018
Study Completion
September 1, 2018
Last Updated
March 10, 2026
Record last verified: 2026-03