PregnancyNCT06314009
Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy
An observational study of Pregnancy, run by Endeavor Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- functional Magnetic Resonance Imaging (fMRI)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Singleton pregnancy, less than 24 weeks gestation
- Pre-pregnancy BMI between 18.5 - 24.9kg/m2 or ≥30kg/m2
Who cannot join
- Asthma on controller medication
- Autoimmune Conditions
- Chronic Hypertension
- Claustrophobia
- Congenital Anomaly
- Pregestational Diabetes
Show all 11Show fewer
- History of Bariatric Surgery
- HIV
- Ineligible for MRI (incompatible implanted medical device)
- Multifetal Gestation
- Smoking during pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Caitlin MacGregor, MD, caitlin.macgregor@endeavorhealth.org
About this study
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
- Being tested
- functional Magnetic Resonance Imaging (fMRI)
- Keywords
- Placenta, MRI, BMI, Weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight | Body Mass Index (BMI) 18.5-24.9 kg/m^2 Receives: Diagnostic Test: functional Magnetic Resonance Imaging (fMRI) | |
| Obese | Pre-pregnancy Body Mass Index (BMI) ≥ 30.0 kg/m^2 Receives: Diagnostic Test: functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL)
Evaluated using a two-way mixed intraclass correlation coefficient for consistency
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 6 weeks after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start9 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin MacGregor, Endeavor Health
- Investigators
- Caitlin MacGregor, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314009
- Sponsor's protocol ID
- EH23-302
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy
- ClinicalTrials.gov ID
- NCT06314009
- Acronym / sponsor ID
- EH23-302
- Conditions
- Pregnancy
- Keywords
- Placenta, MRI, BMI, Weight
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Weight | – | Diagnostic Test: functional Magnetic Resonance Imaging (fMRI)Body Mass Index (BMI) 18.5-24.9 kg/m^2 |
| Obese | – | Diagnostic Test: functional Magnetic Resonance Imaging (fMRI)Pre-pregnancy Body Mass Index (BMI) ≥ 30.0 kg/m^2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Singleton pregnancy, less than 24 weeks gestation
- Pre-pregnancy BMI between 18.5 - 24.9kg/m2 or ≥30kg/m2
Key exclusion criteria (11 listed)
- Asthma on controller medication
- Autoimmune Conditions
- Chronic Hypertension
- Claustrophobia
- Congenital Anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Normal Weight, Obese |
Primary outcome
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
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin MacGregor principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Mangus ((847) 570-2243, alexandra.mangus@endeavorhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL) (time frame: 6 weeks after the delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.