Clinical trial NCT06314009: Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy
Official title: Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Placenta Diseases
Keywords: Placental Perfusion
Placental oxygenation
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at 20-24 weeks gestation. 15 obese (OB) women and 15 normal weight (NL) 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 NL is defined as pre-pregnancy body mass index between 18.5-24.9 kg/m2 without comorbidities.

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.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy

Exclusion Criteria:

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

Primary outcomes:
measure: Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL)
timeFrame: 6 weeks after the delivery
measure: Mean placental perfusion in second and third trimester
timeFrame: 6 weeks after the delivery
measure: Mean R2* relaxation rates in second and third trimester
timeFrame: 6 weeks after the delivery
Secondary outcomes:
measure: Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth.
timeFrame: 6 weeks after the delivery
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Caitlin MacGregor
role: PRINCIPAL_INVESTIGATOR
References: