- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01092949
Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75015
- Necker Enfants Malades
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women > 18 years,
- Undergoing TOP for fetal reason,
- Informed signed consent.
Exclusion Criteria:
- Placental adhesion anomaly,
- Growth restriction,
- Contrast agent allergy,
- Absent consent,
- Contraindication of MRI or Gadolinium,
- Renal insufficiency,
- Placental abnormality at pathological examination.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establishment of physiological reference range of placental perfusion
Time Frame: 45 MIN
|
Establishment of physiological reference range of placental perfusion
|
45 MIN
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
45 MIN
|
Comparison between the two measurements methods.
Time Frame: 45 MIN
|
45 MIN
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laurent Salomon, MCU PH, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P 081111
- 2009-A01024-63 (Registry Identifier: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Placental Insufficiency
-
Sara VareaCompleted
-
Les Laboratoires des Médicaments StérilesCompletedPlacental Insufficiency | EnoxaparinTunisia
-
Maisonneuve-Rosemont HospitalUniversité de MontréalCompletedPlacental OxygenationCanada
-
Fundacion para la Salud Materno InfantilCompleted
-
Anup Katheria, M.D.CompletedPlacental TransfusionUnited States
-
Fundacion para la Salud Materno InfantilTerminated
-
Mansoura University Children HospitalCompletedPreterm Infant | Placental Transfusion | Placental InsufficiencyEgypt
-
Policlinico Abano TermeUnknown
-
Ankara UniversityUnknownPlacental Transfusion | Stem Cells
-
Wafaa Uthman AhmedAin Shams Maternity HospitalUnknownCARBETOCIN FOR PREVENTION OF PLACENTAL RETAINEDEgypt
Clinical Trials on MRI
-
Cambridge University Hospitals NHS Foundation TrustRecruitingBreast CancerUnited Kingdom
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Assistance Publique Hopitaux De MarseilleActive, not recruitingMultiple SclerosisFrance
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedOsteosarcoma | Ewing Sarcoma | Paget's DiseaseUnited States
-
Abbott Medical DevicesCompletedAdverse Effect of MRI on an Implanted Pacemaker Lead | Adverse Effect of MRI on an Implanted PacemakerUnited States, Netherlands, Australia, Belgium, Finland
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
-
University of EdinburghActive, not recruiting
-
Assistance Publique - Hôpitaux de ParisUnknownBrain Injury, Coma | Cardiac Arrest (CA) | Traumatic Brain Injury (TBI) | Aneurysmal Subarachnoid Hemorrhages (aSAH)France
-
Sheba Medical CenterUnknown
-
The Hospital for Sick ChildrenEnrolling by invitation