Viewing Study NCT06314009



Ignite Creation Date: 2024-05-06 @ 8:15 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06314009
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-15
First Post: 2024-02-16

Brief Title: Beyond MARS Magnetic Resonance Study A Novel Assessment of Placental Perfusion During Pregnancy
Sponsor: NorthShore University HealthSystem
Organization: NorthShore University HealthSystem

Study Overview

Official Title: Beyond MARS Magnetic Resonance Study A Novel Assessment of Placental Perfusion During Pregnancy
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 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: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None