PregnancyNCT02791568
Advanced MRI for Uteroplacental Flow, Perfusion, Oxygenation & Inflammation
An observational study of Pregnancy and Obesity, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Obesity, Preeclampsia
- What is being tested?
- Ultrasound Scan, MRI Scan and Ferumoxytol
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 121 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2017to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant Women (<14 weeks gestation)
Who may be able to join
- 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
Who cannot join
- 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
- Subject Population (Main study) Inclusion Criteria
Show all 28Show fewer
- 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)
- Ultrasound confirmed pregnancy dating prior to 14 weeks gestation
- Gestational age at screening prior to 16 weeks
- Control and Study Groups:
- Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy
- Tobacco/alcohol/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
- The determination of whether or not the subjects are considered high risk for the conditions described above will be based on medical and obstetrical history review by clinical investigators with expertise in Maternal Fetal Medicine.
- Contraindications to MRI (such as claustrophobia, metallic implant, etc.) based on MRI Screening
- Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
- Any physical or psychological symptom, based on the clinical judgment of the study physician that would make a participant unsuitable for the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UnityPoint Health-Meriter Hospital
Madison, Wisconsin, 53715
University of Wisconsin-Hospitals and Clinics
Madison, Wisconsin, 53715
About this study
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.
Read the detailed description
Decreased uteroplacental perfusion is a recognized antecedent event in pregnancies that ultimately results in adverse outcomes like fetal growth restriction (FGR), preeclampsia (PE) and/or preterm birth. This concept is well supported clinically by identification of spiral artery vascular lesions called acute atherosis. Current literature suggests that these events occur very early which is why we are using multiple techniques related to flow at early time points. We are studying individuals with either poor maternal vascular response and/or inadequate spiral artery remodeling with resultant inadequate placentation will have a reduced uteroplacental perfusion. Given that the spiral arteries draw the vast majority of the blood flow in a gravid state, poor placentation would be reflected in the total uteroplacental blood flow (UPBF), and early detection would allow both design and then routine initiation of novel preventive therapies early in gestation to improve pregnancy outcome.
The goal of this research is to develop an arsenal of advanced ultrasound (U/S) and magnetic resonance imaging (MRI) techniques that are compatible to be run simultaneously or sequentially to probe uteroplacental health and overcome the limitations posed by obesity and motion. While safety concerns remain with MRI, particularly in the first trimester, we will front-load developmental and optimization studies in primate models as "proof of principle" before translating to humans; this conservative approach is key to our achieving paradigm shifting outcomes. A pilot study was completed prior to the main study to evaluate U/S Doppler and 2D PC MRI for UPBF measures that including contributions from the ovarian arteries in addition to the uterine arteries. The pilot study is now complete as the pilot data was evaluated after the enrolled pilot subjects completed the U/S and 2D PC MRI visits.
We are matching all imaging measures with clinical data and blood and urine sample post-hoc analyses for cytokines and tissue-specific metalloproteases, these correlations will further inform a differential diagnosis of distinct disease mechanisms that may otherwise show common imaging outcomes. At the end of the studies on both lean and obese women, we will inevitably have outcomes categorized as FGR, hypertensive and/or PE, perhaps preterm and/or rarely stillbirth outcomes. Using this combination of approaches we will determine: 1) an optimal combination of imaging methods that is practical and sufficiently safe to use in humans; 2) if new data so derived is informative beyond that currently available clinically; 3) at what point in gestation an abnormality may be detected by these new methods relative to current standard clinical measures and/or diagnoses; and 4) if imaging outcomes can predict specific complications, or only warn of a higher risk of general complications.
The primary objective of the ferumoxytol research, conducted under the pending Investigational New Drug Application, is to demonstrate homing of macrophages in vivo in the decidua of pregnancies with reduced uteroplacental blood-flow and perfusion. The secondary objective is to develop a test of placenta function in on-going pregnancies in subjects with reduced uteroplacental blood flow and perfusion. To evaluate these objectives, subjects with and without reduced total uterine blood-flow and possible reduced placental perfusion will receive Ferumoxytol (Feraheme®) prior to dynamic sequences magnetic resonance.
- Conditions
- Pregnancy, Obesity, Preeclampsia
- Being tested
- Ultrasound Scan, MRI Scan, Ferumoxytol
- Medical subject headings
- Obesity, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScanProcedure or surgery
The research exam is expected to take 30 minutes for blood flow assessments
MRI ScanProcedure or surgery
MR imaging will take approximately 30 minutes.
FerumoxytolDrug
Also called Feraheme®
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Study | 1. Ultrasound Scan
2. MRI Scan
3. Blood/Urine collection Receives: Procedure: Ultrasound Scan; Procedure: MRI Scan | |
| Main Study- Control Group | 1. Ultrasound Scan
2. MRI Scan
3. Blood/Urine collection Receives: Procedure: Ultrasound Scan; Procedure: MRI Scan | |
| Main Study- Study Group | 1. Ultrasound Scan
2. MRI Scan
3. Blood/Urine collection Receives: Procedure: Ultrasound Scan; Procedure: MRI Scan | |
| Main Study- Ferumoxytol Group | 1. Ultrasound Scan
2. MRI Scan
3. Blood/Urine collection
4. Ferumoxtyol Infusion Receives: Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Correlation between reduction in uteroplacental flow and perfusion with Fetal Growth Restriction and Preeclampsia.. Are reductions in uteroplacental flow, perfusion, or Oxygenation at 14, 20, 24 weeks correlated to Fetal Growth Restriction/Preeclamptic (FGR/PE) outcome?
Measured: Through study completion, an average of 4 years
Ferumoxytol (FE) detection at the maternal fetal interface as assessed by R2* and QSM
Determination of immune cell redistribution at the Maternal Fetal Interface (MFI) via Fe-MR as a predictor of adverse pregnancy outcome
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start31 Jan 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Dinesh Shah, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791568
- Sponsor's protocol ID
- 2015-1222
- Other IDs
- A532800, SMPH\OBSTET & GYNECOL\OB-GYN, 1U01HD087216-01, Protocol Version 12/17/2019
- Status last verified
- May 2022
- First submitted
- 1 Feb 2016
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MRI for Uteroplacental Flow, Perfusion, Oxygenation & Inflammation
- ClinicalTrials.gov ID
- NCT02791568
- Acronym / sponsor ID
- 2015-1222
- Conditions
- Pregnancy, Obesity, Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Decreased uteroplacental perfusion is a recognized antecedent event in pregnancies that ultimately results in adverse outcomes like fetal growth restriction (FGR), preeclampsia (PE) and/or preterm birth. This concept is well supported clinically by identification of spiral artery vascular lesions called acute atherosis. Current literature suggests that these events occur very early which is why we are using multiple techniques related to flow at early time points. We are studying individuals with either poor maternal vascular response and/or inadequate spiral artery remodeling with resultant inadequate placentation will have a reduced uteroplacental perfusion. Given that the spiral arteries draw the vast majority of the blood flow in a gravid state, poor placentation would be reflected in the total uteroplacental blood flow (UPBF), and early detection would allow both design and then routine initiation of novel preventive therapies early in gestation to improve pregnancy outcome.
The goal of this research is to develop an arsenal of advanced ultrasound (U/S) and magnetic resonance imaging (MRI) techniques that are compatible to be run simultaneously or sequentially to probe uteroplacental health and overcome the limitations posed by obesity and motion. While safety concerns remain with MRI, particularly in the first trimester, we will front-load developmental and optimization studies in primate models as "proof of principle" before translating to humans; this conservative approach is key to our achieving paradigm shifting outcomes. A pilot study was completed prior to the main study to evaluate U/S Doppler and 2D PC MRI for UPBF measures that including contributions from the ovarian arteries in addition to the uterine arteries. The pilot study is now complete as the pilot data was evaluated after the enrolled pilot subjects completed the U/S and 2D PC MRI visits.
We are matching all imaging measures with clinical data and blood and urine sample post-hoc analyses for cytokines and tissue-specific metalloproteases, these correlations will further inform a differential diagnosis of distinct disease mechanisms that may otherwise show common imaging outcomes. At the end of the studies on both lean and obese women, we will inevitably have outcomes categorized as FGR, hypertensive and/or PE, perhaps preterm and/or rarely stillbirth outcomes. Using this combination of approaches we will determine: 1) an optimal combination of imaging methods that is practical and sufficiently safe to use in humans; 2) if new data so derived is informative beyond that currently available clinically; 3) at what point in gestation an abnormality may be detected by these new methods relative to current standard clinical measures and/or diagnoses; and 4) if imaging outcomes can predict specific complications, or only warn of a higher risk of general complications.
The primary objective of the ferumoxytol research, conducted under the pending Investigational New Drug Application, is to demonstrate homing of macrophages in vivo in the decidua of pregnancies with reduced uteroplacental blood-flow and perfusion. The secondary objective is to develop a test of placenta function in on-going pregnancies in subjects with reduced uteroplacental blood flow and perfusion. To evaluate these objectives, subjects with and without reduced total uterine blood-flow and possible reduced placental perfusion will receive Ferumoxytol (Feraheme®) prior to dynamic sequences magnetic resonance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilot Study | – | Procedure: Ultrasound Scan, Procedure: MRI Scan1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection |
| Main Study- Control Group | – | Procedure: Ultrasound Scan, Procedure: MRI Scan1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection |
| Main Study- Study Group | – | Procedure: Ultrasound Scan, Procedure: MRI Scan1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection |
| Main Study- Ferumoxytol Group | – | Drug: Ferumoxytol1. Ultrasound Scan 2. MRI Scan 3. Blood/Urine collection 4. Ferumoxtyol Infusion |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant Women (<14 weeks gestation)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ScanThe research exam is expected to take 30 minutes for blood flow assessments | Procedure or surgery | Main Study- Control Group, Main Study- Study Group, Pilot Study |
| MRI ScanMR imaging will take approximately 30 minutes. | Procedure or surgery | Main Study- Control Group, Main Study- Study Group, Pilot Study |
| FerumoxytolAlso: Feraheme®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. | Drug | Main Study- Ferumoxytol Group |
Primary outcome
Uteroplacental blood flow as assessed by doppler ultrasound, two dimensional phase contrast magnetic resonance imaging, and four dimensional flow magnetic resonance imaging.
Time frame: Through study completion, an average of 4 years
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.
2 secondary outcomes
Magnetic resonance perfusion and oxygenation as assessed by various U/S and MRI imaging techniques.
Time frame: Through study completion, an average of 4 years
Ferumoxytol (FE) detection at the maternal fetal interface as assessed by R2* and QSM
Time frame: Through study completion, an average of 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinesh Shah, MD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Obesity, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uteroplacental blood flow as assessed by doppler ultrasound, two dimensional phase contrast magnetic resonance imaging, and four dimensional flow magnetic resonance imaging. (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.