MRI Assessment of Placental Health
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|ClinicalTrials.gov Identifier: NCT02297724|
Recruitment Status : Recruiting
First Posted : November 21, 2014
Last Update Posted : July 27, 2020
The ultimate goal of this project is to develop methods that allow informed decision-making on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies. Although there is no specific correspondence between a single type of pathology and IUGR, the common result of these pathologies is placental insufficiency, which limits the maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and inflammation in the villous and intervillous space (villitis). Thus one potential approach to distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental transport. Based on the hypothesis that efficiency of oxygen transport is representative for overall oxygen and nutrition transport in placenta, the investigators propose to characterize the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use it as an index for better stratification in the IUGR risk group. The investigators will also consider alternative MRI approaches such as structural, diffusion and spectroscopy measurements inside the placenta, which might reflect the state of placental transport and reveal the status of placental health.
Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency from normal placenta transport with histopathology data of the placenta. 2) To correlate the MRI metrics that reflects placental insufficiency with fetal outcome
|Condition or disease||Intervention/treatment|
|Intrauterine Growth Restriction||Other: Oxygen|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||MRI Assessment of Placental Health|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2025|
For all subjects, administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan. Data collection will start about 10 min before the administration of oxygen, and last throughout the oxygen exposure, then continue for about 10 min after oxygen exposure for each subject.
Administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan.
- BOLD MRI signal change during maternal oxygen exposure in placenta and fetus [ Time Frame: 30 min during the 1 hour scan ]
- placental volume on MRI image [ Time Frame: 5 min during 1 hour scan ]
- pathological reports of placenta after delivery [ Time Frame: 1 day ]
- fetal growth curve after birth [ Time Frame: up to 6 month ]
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): NCT02297724
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Patricia E Grant, MD 857-218-5111 email@example.com|
|Hospital Universitario de Fuenlabrada||Recruiting|
|Madrid, Spain, 28942|
|Contact: Maria Teulon Gonzalez, MD PhD 916006252 firstname.lastname@example.org|
|Principal Investigator:||Patricia E Grant, MD||Boston Children's Hospital|