Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
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|ClinicalTrials.gov Identifier: NCT01092949|
Recruitment Status : Unknown
Verified April 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : March 25, 2010
Last Update Posted : April 19, 2016
|Condition or disease||Intervention/treatment|
|Placental Insufficiency||Device: MRI|
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.
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.
- 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 :||Observational|
|Actual Enrollment :||135 participants|
|Official Title:||Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||September 2016|
- Establishment of physiological reference range of placental perfusion [ Time Frame: 45 MIN ]Establishment of physiological reference range of placental perfusion
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092949
|Necker Enfants Malades|
|Paris, France, 75015|
|Principal Investigator:||Laurent Salomon, MCU PH||Assistance Publique - Hôpitaux de Paris|