MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2018
CompletedStudy Start
First participant enrolled
November 29, 2018
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMay 18, 2023
May 1, 2023
1.5 years
November 29, 2018
May 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Placenta ratio of oxygenated hemoglobin to deoxygenated hemoglobin
1 day
Placenta ratio of choline to lipid
1 day
Study Arms (3)
Normal weight
BMI 18.5-24.9 kg/m\^2 low risk pregnancy
Pregestational diabetes mellitus
Type 1 or Type 2 diabetes mellitus diagnosed prior to the pregnancy or in the first trimester
Obese
Pre-pregnancy BMI ≥ 30.0 kg/m\^2
Interventions
Participants will undergo a functional MRI using multiple imaging modalities.
Eligibility Criteria
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.
You may qualify if:
- singleton pregnancy
- planned cesarean section
You may not qualify if:
- non-English speaking
- fetal anomalies
- gestational diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Endeavor Healthlead
Study Sites (1)
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Biospecimen
Maternal and fetal cord plasma. Placental extracts. Formalin-fixed placental specimens.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Plunkett, MD, MPH
Endeavor Health
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical associate professor
Study Record Dates
First Submitted
November 29, 2018
First Posted
December 5, 2018
Study Start
November 29, 2018
Primary Completion
May 20, 2020
Study Completion
June 1, 2020
Last Updated
May 18, 2023
Record last verified: 2023-05