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

NCT ID: NCT06314009

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-09

Study Completion Date

2026-12-31

Brief Summary

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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) using arterial spin labeling (ASL). 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 Magnetic Resonance Imaging scans (MRIs), the first in the second trimester at 20-24 weeks and the second in the third trimester at 30-34 weeks.

Detailed Description

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The transfer of oxygen and nutrients from the mother to the baby across the placenta is essential to successful pregnancy outcomes. Conversely, poor transfer of oxygen from the mother to the baby through the placenta is associated with adverse outcomes, including poor fetal growth, preterm delivery, and stillbirth. Babies need oxygen to maintain good health. Babies born to women who are obese before pregnancy have a higher risk of experiencing health problems in pregnancy and long-term health problems such as metabolic syndrome, obesity, and diabetes. Obesity has continued to increase in the United States over the past decades, and a quarter of pregnancy complications, such as preterm birth, gestational diabetes, hypertension, and large gestational infants, can be attributed to maternal obesity.

In this study, the investigators propose using a novel method, arterial spin labeling (ASL)) to measure placental blood flow. The study aims to evaluate the feasibility and reliability of assessing placental blood flow by this novel method. The investigators will also evaluate the mean global placental perfusion of second and third trimester placentas among obese women as compared to those with a normal weight before pregnancy. To provide an innovative and comprehensive evaluation of placental oxygen delivery and insights into the delivery of nutrients, investigators will compare global placental perfusion of second and third trimester placentas with measurements of placental oxygenation by R2\* relaxation rates.

Conditions

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Placenta Diseases

Keywords

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Placental Perfusion Placental oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Weight

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

functional Magnetic Resonance Imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

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

Obese

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

functional Magnetic Resonance Imaging (fMRI)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy

Exclusion Criteria

* multifetal gestation
* congenital anomaly
* claustrophobia, or ineligible for MRI (incompatible implanted medical device)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Endeavor Health

OTHER

Sponsor Role lead

Responsible Party

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Caitlin MacGregor

Physician, Fpa

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caitlin MacGregor

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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NorthShore University HealthSystem

Evanston, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kate Honeyfield

Role: CONTACT

Phone: (847) 570-2243

Email: [email protected]

Caitlin A MacGregor

Role: CONTACT

Phone: (847) 570-4729

Email: [email protected]

Facility Contacts

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Caitlin MacGregor, MD

Role: primary

Other Identifiers

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EH23-302

Identifier Type: -

Identifier Source: org_study_id