Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: functional Magnetic Resonance Imaging (fMRI).
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test functional Magnetic Resonance Imaging (fMRI)
Participants will undergo a functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL) and other Magnetic Resonance (MR) sequences
Primary outcome measures
- Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL) [Time frame: 6 weeks after the delivery]
- Mean placental perfusion in second and third trimester [Time frame: 6 weeks after the delivery]
- Mean R2* relaxation rates in second and third trimester [Time frame: 6 weeks after the delivery]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Endeavor Health — Evanston
Identifiers
NCT: NCT06314009 · EH23-302