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NCT Number: NCT06314009

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

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)

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Key information

Conditions

Pregnancy Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Endeavor Health

Evanston, Illinois, 60201, United States

Location status: Recruiting

Location contact

Caitlin MacGregor, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 6 weeks after the delivery

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

  2. Mean placental perfusion in second and third trimester

    Time frame: 6 weeks after the delivery

    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.

  3. Mean R2* relaxation rates in second and third trimester

    Time frame: 6 weeks after the delivery

    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.

Secondary outcomes

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

    Time frame: 6 weeks after the delivery

    The prevalence and incidence of outcomes such as hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU (Neonatal Intensive Care Unit) admission, stillbirth will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Mangus

CONTACT

[email protected]

(847) 570-2243

Caitlin A MacGregor, MD

CONTACT

[email protected]

(847) 570-4729

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Mar 16, 2026

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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