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MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function

MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03764878
Enrollment
15
Registered
2018-12-05
Start date
2018-11-29
Completion date
2020-06-01
Last updated
2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Diseases

Brief summary

The objective of this study is to evaluate functional MRI as a tool to study placental transfer of oxygen and nutrients during the third trimester of pregnancy in obese women, women with pregestational diabetes and healthy low risk women without these conditions (controls). The investigators hypothesize that altered placental function, including diminished placental oxygenation and enhanced placental transport of lipids and metabolites will be seen in obese and pregestational diabetics as compared to controls.

Detailed description

In this study, we propose to utilize two novel and innovative non-invasive tools to measure placental oxygenation and lipid and nutrient transport in vivo in women who are obese (OB), have pregestational diabetes (DM) or have neither (controls). To evaluate differences in placental oxygenation, we propose to use Blood Oxygen Level Depending (BOLD) imaging, a method of functional magnetic resonance imaging, to measure tissue oxygenation in the placenta during the third trimester of pregnancy. To evaluate placental lipid and nutrient content, we propose to utilize Magnetic Resonance Spectroscopy (MRS), a novel and powerful tool to compare lipid and nutrient transport across the placenta among OB, DM and controls. To confirm in vivo BOLD and MRS findings, we will extensively evaluate the placental lipid content and lipid transport capability. Fatty acid transport protein-4 (FATP-4), one of 6 FATP proteins, is important for placental lipid accumulation, especially LC-PUFA21-24. Docosahexaenoic acid (DHA) is a crucial LC-PUFA for neurogenesis in early development18. Major facilitator super family domain containing MFSD2a is a lysophospholipid transporter required for DHA uptake in the brain and has been linked to placental DHA transfer. Lipid content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the most abundant structural protein on the surface of lipid droplets of adipocytes. We hypothesize that altered placental function including diminished placental oxygenation and abnormal placental transport of lipids and other metabolites will be seen in OB and DM women as compared to controls. We further hypothesize that ex vivo placental pathologic, histologic and immunohistochemistry characteristics will be associated with in vivo findings. Our findings from this pilot study have the potential to serve as the basis of a larger study to further evaluate the potential impact of BOLD and MRS technology on our understanding of placental lipid and oxygen transport among women with obesity and pregestational diabetes as compared to women without these conditions.

Interventions

DIAGNOSTIC_TESTfunctional MRI

Participants will undergo a functional MRI using multiple imaging modalities.

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* singleton pregnancy * planned cesarean section

Exclusion criteria

* non-English speaking * fetal anomalies * gestational diabetes mellitus

Design outcomes

Primary

MeasureTime frameDescription
Change in BOLD response level in the placenta1 dayAs measured by the change in MRI from baseline (room air) compared to hyperoxygenation (O2 facemask) in the central area of the placenta

Secondary

MeasureTime frameDescription
Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin1 dayAs measured on MRI during third trimester in the central area of the placenta
Placenta ratio of choline to lipid1 dayAs measured on MRI during third trimester in the central area of the placenta

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026