Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorEndeavor Health
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton pregnancy, less than 24 weeks gestation
Pre-pregnancy BMI between 18.5 - 24.9kg/m2 or ≥30kg/m2
Disqualifiers
Asthma on controller medication
Autoimmune Conditions
Chronic Hypertension
Claustrophobia
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
functional Magnetic Resonance Imaging (fMRI)
Diagnostic testParticipants will undergo a functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL) and other Magnetic Resonance (MR) sequences
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Normal Weight1 intervention
Group B: Obese1 intervention
Trial outcomes
Primary outcomes
1
Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL)
Evaluated using a two-way mixed intraclass correlation coefficient for consistency
Time frame
6 weeks after the delivery2
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.
Time frame
6 weeks after the delivery3
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.
Time frame
6 weeks after the deliverySecondary 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.
Time frame
6 weeks after the deliverySponsors and contacts
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Source ClinicalTrials.gov