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

Placenta Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764878
• Other study ID #: EH18-300
• Status: Completed
• Start date: November 29, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2023
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 1, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• singleton pregnancy
• planned cesarean section

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Placenta Diseases

Intervention

Diagnostic Test:
• functional MRI
Participants will undergo a functional MRI using multiple imaging modalities.

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin	As measured on MRI during third trimester in the central area of the placenta	1 day
Secondary	Placenta ratio of choline to lipid	As measured on MRI during third trimester in the central area of the placenta	1 day