Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy

NCT06314009 | Recruiting

• 1 other identifier: EH23-302
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy. This study will evaluate blood flow across the placenta by functional Magnetic Resonance Imaging (fMRI). The investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight. Participants will be asked to complete:

• MRI in the second trimester (20-24 weeks)
• MRI in the third trimester (30-34 weeks)

Conditions

Pregnancy

Keywords

Placenta; MRI; BMI; Weight

Outcome Measures

Primary Outcomes (3)

• Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL)

  Evaluated using a two-way mixed intraclass correlation coefficient for consistency

  6 weeks after the delivery

• Mean placental perfusion in second and third trimester

  The mean global placental perfusion of second and third-trimester placentas among participants with obesity (Body Mass Index measured in kg/m\^2, calculated using weight in kilograms and height in meters) as compared to those with a normal weight (kilograms) before pregnancy will be evaluated.

  6 weeks after the delivery

• Mean R2* relaxation rates in second and third trimester

  the Mean R2\* relaxation rates will be used to correlate the global placental perfusion of second and third trimester placentas with measurements of placental oxygenation.

  6 weeks after the delivery

Secondary Outcomes (1)

• Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth.

  6 weeks after the delivery

Study Arms (2)

Normal Weight

Body Mass Index (BMI) 18.5-24.9 kg/m\^2

Diagnostic Test: functional Magnetic Resonance Imaging (fMRI)

Obese

Pre-pregnancy Body Mass Index (BMI) ≥ 30.0 kg/m\^2

Diagnostic Test: functional Magnetic Resonance Imaging (fMRI)

Interventions

functional Magnetic Resonance Imaging (fMRI) DIAGNOSTIC_TEST

Participants will undergo a functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL) and other Magnetic Resonance (MR) sequences

Normal Weight; Obese

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant people at 20-24 weeks gestation. 15 obese (OB) women and 15 normal weight (NW) will be recruited to participate in the study. OB is defined as pre-pregnancy body mass index greater than or equal to 30 kg/m2, and NW is defined as pre-pregnancy body mass index between 18.5-24.9 kg/m2 without comorbidities.

You may qualify if:

• Singleton pregnancy, less than 24 weeks gestation
• Pre-pregnancy BMI between 18.5 - 24.9kg/m2 or ≥30kg/m2

You may not qualify if:

• Asthma on controller medication
• Autoimmune Conditions
• Chronic Hypertension
• Claustrophobia
• Congenital Anomaly
• Pregestational Diabetes
• History of Bariatric Surgery
• HIV
• Ineligible for MRI (incompatible implanted medical device)
• Multifetal Gestation
• Smoking during pregnancy

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Conditions

Body Weight

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Caitlin MacGregor

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Mangus

CONTACT

(847) 570-2243; alexandra.mangus@endeavorhealth.org

Caitlin A MacGregor, MD

CONTACT

(847) 570-4729; caitlin.macgregor@endeavorhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Fpa

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 15, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)