MRI Assessment of Placental Health
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Boston Children's Hospital
- Study ID
- NCT02297724
- Status
- Recruiting
Conditions
- Intrauterine Growth Restriction
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- Oxygen — OTHERAdministration 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.
Study Details
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
Key Dates
- Start date
- Apr 30, 2014
- Status verified
- Dec 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 80 participants (estimated)
Arms
- Arm: all subjectsFor 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.
Primary Outcome Measure
BOLD MRI signal change during maternal oxygen exposure in placenta and fetus [ Time Frame: 30 min during the 1 hour scan ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 |
Find similar trials in Boston, MA
Related Studies
- A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in BoliviaRecruiting · Massachusetts General Hospital · Boston, Massachusetts
- Growing Little PEAPODS StudyRecruiting · University of Wisconsin, Madison · Madison, Wisconsin