Advanced MRI for Uteroplacental Flow, Perfusion, Oxygenation & Inflammation

NCT02791568 | Completed DMC FDA Drug

• 5 other identifiers: 2015-1222A532800SMPH\OBSTET & GYNECOL\OB-GYN1U01HD087216-01Protocol Version 12/17/2019
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to develop advanced ultrasound (U/S) and Magnetic Resonance Imaging, known as MRI to study uteroplacental health. The goal of this study is to evaluate the blood and oxygen flow to the placenta using advanced U/S and MRI testing.

Conditions

Pregnancy; Obesity; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Uteroplacental blood flow as assessed by doppler ultrasound, two dimensional phase contrast magnetic resonance imaging, and four dimensional flow magnetic resonance imaging.

  The goal of this research is to develop an arsenal of advanced U/S and MRI techniques that are compatible to be run simultaneously or sequentially to probe uteroplacental health and overcome the limitations posed by obesity and motion.The ideal combination of imaging procedures will help to progress with further human studies that actually benefit clinical diagnosis.

  Through study completion, an average of 4 years

Secondary Outcomes (2)

• Magnetic resonance perfusion and oxygenation as assessed by various U/S and MRI imaging techniques.

  Through study completion, an average of 4 years

• Ferumoxytol (FE) detection at the maternal fetal interface as assessed by R2* and QSM

  Through study completion, an average of 4 years

Study Arms (4)

Pilot Study

1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection

Procedure: Ultrasound Scan; Procedure: MRI Scan

Main Study- Control Group

1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection

Procedure: Ultrasound Scan; Procedure: MRI Scan

Main Study- Study Group

1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection

Procedure: Ultrasound Scan; Procedure: MRI Scan

Main Study- Ferumoxytol Group

1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection 4. Ferumoxtyol Infusion

Drug: Ferumoxytol

Interventions

Ultrasound Scan PROCEDURE

The research exam is expected to take 30 minutes for blood flow assessments

Main Study- Control Group; Main Study- Study Group; Pilot Study

MRI Scan PROCEDURE

MR imaging will take approximately 30 minutes.

Main Study- Control Group; Main Study- Study Group; Pilot Study

Ferumoxytol DRUG

A subset of subjects will complete MRI imaging with ferumoxytol as a contrast agent at the 24-28 week visit. A nurse will administer ferumoxytol in a hospital triage with pulse and blood pressure monitoring and fetal heart monitoring. The pharmacy will prepare the infusion and deliver to triage. Subjects will arrive at the obstetric triage unit for ferumoxytol injection three days prior to their scheduled ferumoxytol MRI study. In the triage, the nurse will obtain baseline vital signs and fetal heart rate. The IV Ferumoxytol infusion will be 30 minutes and atients will be monitored at 5 to 15-minute intervals. Three days after the ferumoxytol infusion, at 24-26 weeks gestation, subjects will have blood/urine collected, undergo a 30 minute ultrasound, a 30 minute MRI, an adverse event review, and medical record review. The MRI scanning procedure will be conducted at WIMR and will last approximately 30-60 minutes.

Also known as: Feraheme®

Main Study- Ferumoxytol Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant Women (\<14 weeks gestation)

You may qualify if:

• Women with singleton, low-risk pregnancies
• Gravida 1 (first pregnancy); or Gravida 2 (second pregnancy with first pregnancy carried to term or miscarried prior to 14 weeks or terminated); or Gravida 3 (third pregnancy with first and second pregnancies carried to term or one previous pregnancy carried to term and the other previous pregnancy miscarried prior to 14 weeks or terminated)
• Ultrasound confirmed pregnancy dating prior to 14 weeks gestation
• Non-obese (BMI 18.5-29.9 kg/M2) or Obese (Class I BMI 30-34.9 kg/M2 or Class II BMI 35-39.9 kg/M2) based on pregravid BMI

You may not qualify if:

• Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy
• Tobacco or alcohol or drug use in current pregnancy
• Pre-existing autoimmune conditions or other maternal chronic diseases like renal diseases, chronic hypertension, thrombophilia, type I or II diabetes or any vasculopathy
• History of sickle cell anemia or sickle cell trait
• High risk for gestational hypertension, pre-eclampsia, HELLP syndrome, fetal growth restriction (FGR), abruptio placentae secondary to hypertension or pre-eclampsia, stillbirth/intrauterine fetal death
• Control Group:
• Non-obese (pregravid BMI 18.5-29.9 Kg/M2)25 (N=80)
• Women with singleton, low-risk pregnancies
• Gravida 1 (first pregnancy); or Gravida 2 (second pregnancy with first pregnancy carried to term or miscarried prior to 14 weeks or terminated); or Gravida 3 (third pregnancy with first and second pregnancies carried to term or one previous pregnancy carried to term and the other previous pregnancy miscarried prior to 14 weeks or terminated)
• Ultrasound-confirmed pregnancy dating prior to 14 weeks gestation
• Gestational age at screening prior to 16 weeks
• Study Group:
• Obese (pregravid Class I BMI 30-34.9 kg/M2 or pregravid Class II BMI 35-39.9 kg/M2) (N=80)
• Women with singleton, low-risk pregnancies
• Gravida 1 (first pregnancy); or Gravida 2 (second pregnancy with first pregnancy carried to term or miscarried prior to 14 weeks or terminated); or Gravida 3 (third pregnancy with first and second pregnancies carried to term or one previous pregnancy carried to term and the other previous pregnancy miscarried prior to 14 weeks or terminated)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

UnityPoint Health-Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin-Hospitals and Clinics

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Obesity; Pre-Eclampsia

Interventions

High-Energy Shock Waves; Magnetic Resonance Spectroscopy; Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Dinesh Shah, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: June 7, 2016
• Study Start: January 31, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 22, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)