Recruiting

Placental Oxygenation

Sponsor:

Endeavor Health

Code:

NCT06314009

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

functional Magnetic Resonance Imaging (fMRI)

Study Details

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). 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

Study ID

NCT06314009

Start date

May 9, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Singleton pregnancy, less than 24 weeks gestation
  • Pre-pregnancy BMI between 18.5 - 24.9kg/m2 or ≥30kg/m2

Exclusion Criteria:

  • Asthma on controller medication
  • Autoimmune Conditions
  • Chronic Hypertension
  • Claustrophobia
  • Congenital Anomaly
  • Pregestational Diabetes
  • History of Bariatric Surgery
  • HIV
  • Ineligible for MRI (incompatible implanted medical device)
  • Multifetal Gestation
  • Smoking during pregnancy

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal Weight

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

Obese

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

Interventions

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

Primary outcome measure

  • Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL) [ Time Frame: 6 weeks after the delivery ]
  • Mean placental perfusion in second and third trimester [ Time Frame: 6 weeks after the delivery ]
  • Mean R2* relaxation rates in second and third trimester [ Time Frame: 6 weeks after the delivery ]

Central Contacts and Locations

Central contacts

Alexandra Mangus

(847) 570-2243alexandra.mangus@endeavorhealth.org

Caitlin A MacGregor, MD

(847) 570-4729caitlin.macgregor@endeavorhealth.org

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Caitlin MacGregor, MD

caitlin.macgregor@endeavorhealth.org

More Information

Sponsor

Endeavor Health

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Placenta
  • MRI
  • BMI
  • Weight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-03-16.