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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06314009
Enrollment
30
Registered
2024-03-15
Start date
2024-05-09
Completion date
2026-12-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Placenta, MRI, BMI, Weight

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)

Interventions

DIAGNOSTIC_TESTfunctional Magnetic Resonance Imaging (fMRI)

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

Sponsors

Endeavor Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL)6 weeks after the deliveryEvaluated using a two-way mixed intraclass correlation coefficient for consistency
Mean placental perfusion in second and third trimester6 weeks after the deliveryThe 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.
Mean R2* relaxation rates in second and third trimester6 weeks after the deliverythe 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

MeasureTime frameDescription
Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth.6 weeks after the deliveryThe 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.

Countries

United States

Contacts

CONTACTAlexandra Mangus
alexandra.mangus@endeavorhealth.org(847) 570-2243
CONTACTCaitlin A MacGregor, MD
caitlin.macgregor@endeavorhealth.org(847) 570-4729
PRINCIPAL_INVESTIGATORCaitlin MacGregor

Endeavor Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026