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.

Study Overview

• Status: Completed
• Conditions: Placenta Diseases
• Intervention / Treatment: Diagnostic test: functional MRI

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at 30-34 weeks gestation who are scheduled for a cesarean delivery. For this pilot project, 10 obese (OB) women, 10 women with pregestational diabetes (PGD) and 10 women without OB or PGD will be recruited. OB is defined as prepregnancy or first trimester BMI greater than or equal to 30 kg/ m2. PGD will be defined as Type 1 or Type 2 diabetes diagnosed prior to the pregnancy or in the first trimester.

Description

Inclusion Criteria:

• singleton pregnancy
• planned cesarean section

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal weight; BMI 18.5-24.9 kg/m^2 low risk pregnancy	Diagnostic test: functional MRI; Participants will undergo a functional MRI using multiple imaging modalities.
Pregestational diabetes mellitus; Type 1 or Type 2 diabetes mellitus diagnosed prior to the pregnancy or in the first trimester	Diagnostic test: functional MRI; Participants will undergo a functional MRI using multiple imaging modalities.
Obese; Pre-pregnancy BMI ≥ 30.0 kg/m^2	Diagnostic test: functional MRI; Participants will undergo a functional MRI using multiple imaging modalities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BOLD response level in the placenta	As measured by the change in MRI from baseline (room air) compared to hyperoxygenation (O2 facemask) in the central area of the placenta	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin	As measured on MRI during third trimester in the central area of the placenta	1 day
Placenta ratio of choline to lipid	As measured on MRI during third trimester in the central area of the placenta	1 day

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem
• Investigators: Principal Investigator: Beth Plunkett, MD, MPH, Northshore University Healthsystem

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Placenta Diseases
• Other Study ID Numbers: EH18-300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No