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OpenTrials
Completed

NCT Number: NCT03764878

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton pregnancy
  • planned cesarean section

Exclusion criteria

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

Treatment and study plan

Functional MRI

Diagnostic Test

Participants will undergo a functional MRI using multiple imaging modalities.

Primary outcomes

  1. Change in BOLD response level in the placenta

    Time frame: 1 day

    As measured by the change in MRI from baseline (room air) compared to hyperoxygenation (O2 facemask) in the central area of the placenta

Secondary outcomes

  1. Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin

    Time frame: 1 day

    As measured on MRI during third trimester in the central area of the placenta

  2. Placenta ratio of choline to lipid

    Time frame: 1 day

    As measured on MRI during third trimester in the central area of the placenta

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2018
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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