Placenta Imaging Project

NCT02749851 | Completed DMC

• 2 other identifiers: OHSU IRB 15196U01HD087182
• Study Type: observational
• Target: 379
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test the application of newly generated magnetic resonance imaging (MRI) protocols for the assessment of placental perfusion in human subjects. The primary objective is to validate and establish the utility of placental MRI in pregnant women. The study will be entirely MRI-technology based with collection of placental tissue at the time of infant delivery for later correlative studies.

Conditions

High Risk Pregnancy

Keywords

pregnancy; growth restriction

Outcome Measures

Primary Outcomes (3)

• Placental perfusion (Units of measure: ml/min) measured at 3 time points across gestation.

  This will allow perfusion changes across pregnancy to be quantified in women from the three study groups.

  Change from 16, 24, and 32 weeks gestation

• Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC)

  Determine the sensitivity and specificity of placental MRI at 16, 24, and 32 weeks gestation for identifying risk of adverse clinical outcome identified later in pregnancy. Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC).

  Change from 16, 24, and 32 weeks gestation

• Composite of placenta-mediated adverse pregnancy outcomes

  A binary variable indication whether the placenta-mediated adverse pregnancy has observed within 39 weeks gestation Composite of placenta-mediated adverse pregnancy outcomes defined as the presence of at least one of the following: 1. Fetal death (not due to genetic or infectious etiology), 2. Preeclampsia or gestational hypertension, 3. Small for gestational age fetus \< 5%, 4. Oligohydramnios (defined as amniotic fluid index (AFI) \< 5 cm) prompting delivery prior to 39 weeks gestation, 5. Abnormal fetal heart rate tracing prompting delivery prior to 39 weeks gestation, 6. Abnormal umbilical artery Doppler velocimetry prompting delivery prior to 39 weeks gestation.

  39 weeks gestation

Secondary Outcomes (4)

• Composite of Placenta histologic outcomes

  39 weeks gestation

• Diagnosis of preeclampsia using standard clinical criteria

  39 weeks gestation

• Small for gestational age fetus at 3% and 5%

  39 weeks gestation

• Gestational age at delivery prior to 37 weeks gestation.

  37 weeks gestation

Study Arms (4)

Non-smokers

Pregnant women that identify as non-smokers with low risk for placental insufficiency will receive the MRI Imaging intervention.

Device: MRI

Smokers

Pregnant women that identify as smokers will receive the MRI Imaging intervention.

Device: MRI

High risk/Non-Smokers

Pregnant women that identify as non-smokers who are at a high risk for adverse outcomes based on prior clinical history will receive the MRI Imaging intervention.

Device: MRI

Confirmed IUGR

Pregnant women identified by their clinical care provided to have confirmed IUGR during their current pregnancy

Device: MRI - IUGR

Interventions

MRI DEVICE

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy in 3 groups of human subjects: 1) non-smokers, 2) smokers, 3) individuals at high risk for adverse outcome. The objective of this work is to develop a new non-invasive clinical tool for early identification of placental dysfunction.

Also known as: magnetic resonance imaging

High risk/Non-Smokers; Non-smokers; Smokers

MRI - IUGR DEVICE

Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy. The objective of this ancillary arm is to further test the sensitivity of placental magnetic resonance imaging to detect abnormal perfusion and oxygenation in confirmed cases of IUGR between gestational ages 28 to 36 weeks.

Also known as: magnetic resonance imaging

Confirmed IUGR

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who plan to deliver at OHSU or University of Utah hospitals and live within the areas served by those medical facilities.

You may qualify if:

• Non-smokers with low risk for placental insufficiency
• Smokers
• Non-smokers who are at a high risk for adverse outcomes based on prior clinical history.

You may not qualify if:

• Maternal age over 18 years and able to give informed consent
• Pregnant patient, as defined by positive pregnancy test for elevated β-human chorionic gonadotropin (HCG) and certain menstrual history, or early ultrasound, identified prior to 14 weeks of gestation
• No history of a second or third trimester loss
• No history of fetal growth restriction
• History of pregnancy complicated by placental insufficiency in a previous singleton pregnancy (i.e. severe preeclampsia requiring preterm delivery, preterm delivery due to placenta insufficiency (eg. fetal growth restriction (FGR), oligohydramnios, abnormal umbilical artery Doppler's, abnormal antenatal testing), FGR \<10% delivered at term; stillbirth attributed to placental cause, regardless of gestational age
• Not currently a smoker
• Pregnancy at risk for placental insufficiency due to clinical concerns (eg. chronic hypertension)
• Spontaneous preterm birth \<34 weeks
• Individuals with intellectual disability or who are incarcerated
• Multiple gestation
• Major fetal anomalies known to be associated with abnormal growth (i.e. major congenital heart defect, gastroschisis)
• Current maternal history of alcohol or illicit drug use
• Current medical problems requiring chronic treatment:
• Cancer
• Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Schabel MC, Roberts VHJ, Gibbins KJ, Rincon M, Gaffney JE, Streblow AD, Wright AM, Lo JO, Park B, Kroenke CD, Szczotka K, Blue NR, Page JM, Harvey K, Varner MW, Silver RM, Frias AE. Quantitative longitudinal T2* mapping for assessing placental function and association with adverse pregnancy outcomes across gestation. PLoS One. 2022 Jul 19;17(7):e0270360. doi: 10.1371/journal.pone.0270360. eCollection 2022.

  PMID: 35853003 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Specimens to be included: Maternal blood (10ml) taken at each MRI visit and prior to delivery Maternal urine taken at each MRI visit and prior to delivery Placental tissue collected at the time of delivery.

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Antonio Frias, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: April 25, 2016
• Study Start: October 13, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)