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Placenta Imaging Project (PIP)

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ClinicalTrials.gov Identifier: NCT02749851
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Antonio E. Frias, Oregon Health and Science University

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.

Condition or disease Intervention/treatment
High Risk Pregnancy Device: MRI Device: MRI - IUGR

Detailed Description:

The placenta provides all the nutrition from a pregnant mother to a developing fetus. A placenta that functions normally is needed to ensure normal fetal growth and development. Unfortunately, the placenta is the least understood human organ even though it is involved in all pregnancy complications. The placenta is so poorly understood because our current methods to look at it during pregnancy, like ultrasound, do not provide enough information about placental growth and function.

This study will help provide information about:

  • How the placenta grows and develops during pregnancy
  • How the placenta delivers nutrients, like oxygen to the developing fetus
  • If placental function using new advanced imaging tools can predict pregnancy complications like fetal growth restriction, stillbirth, preeclampsia and preterm labor

This study will explore how blood flow to the placenta affects placental growth, fetal growth, and oxygen delivery to the fetus. Blood flow to the placenta may determine how the placenta supports fetal growth and development. Having a way to measure placental function during pregnancy may provide a way to understand normal pregnancies but importantly also identify pregnancies at increased risk for pregnancy complications.

Additionally we want to have an ancillary intrauterine growth restriction (IUGR) arm; the objective of this ancillary study is to test the sensitivity of the placental MRI protocol in women with confirmed cases of IUGR in the third trimester.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Imaging of Human Placenta by MRI
Actual Study Start Date : October 13, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non-smokers
Pregnant women that identify as non-smokers with low risk for placental insufficiency will receive the MRI Imaging intervention.
Device: MRI
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.
Other Name: magnetic resonance imaging

Smokers
Pregnant women that identify as smokers will receive the MRI Imaging intervention.
Device: MRI
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.
Other Name: magnetic resonance imaging

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
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.
Other Name: magnetic resonance imaging

Confirmed IUGR
Pregnant women identified by their clinical care provided to have confirmed IUGR during their current pregnancy
Device: MRI - IUGR
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.
Other Name: magnetic resonance imaging




Primary Outcome Measures :
  1. Placental perfusion (Units of measure: ml/min) measured at 3 time points across gestation. [ Time Frame: Change from 16, 24, and 32 weeks gestation ]
    This will allow perfusion changes across pregnancy to be quantified in women from the three study groups.

  2. Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC) [ Time Frame: Change from 16, 24, and 32 weeks gestation ]
    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).

  3. Composite of placenta-mediated adverse pregnancy outcomes [ Time Frame: 39 weeks gestation ]

    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.


Secondary Outcome Measures :
  1. Composite of Placenta histologic outcomes [ Time Frame: 39 weeks gestation ]

    Composite of placental histologic outcomes defined as the presence of one of the following:

    1. accelerated villous maturation
    2. abnormal villous cytotrophoblast proliferation
    3. microscopic infarctions
    4. decidual vasculopathy

  2. Diagnosis of preeclampsia using standard clinical criteria [ Time Frame: 39 weeks gestation ]
  3. Small for gestational age fetus at 3% and 5% [ Time Frame: 39 weeks gestation ]
  4. Gestational age at delivery prior to 37 weeks gestation. [ Time Frame: 37 weeks gestation ]

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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Pregnant women will be recruited based on inclusion criteria for 3 subject groups:

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

Inclusion criteria: Pregnant women fulfilling inclusion criteria, and not meeting exclusion criteria, will be invited to participate in this study.

Inclusion criteria for all groups:

  1. Maternal age over 18 years and able to give informed consent
  2. 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

Inclusion criteria for low risk group:

  1. No history of a second or third trimester loss
  2. No history of fetal growth restriction

Inclusion criteria for high risk group:

  1. 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
  2. Not currently a smoker
  3. Pregnancy at risk for placental insufficiency due to clinical concerns (eg. chronic hypertension)
  4. Spontaneous preterm birth <34 weeks

Exclusion criteria: These criteria will exclude women whose medications, personality traits or obstetric conditions could confound their ability to complete a 1 hour MRI scan.

  1. Individuals with intellectual disability or who are incarcerated
  2. Multiple gestation
  3. Major fetal anomalies known to be associated with abnormal growth (i.e. major congenital heart defect, gastroschisis)
  4. Current maternal history of alcohol or illicit drug use
  5. Current medical problems requiring chronic treatment:

    • Cancer
    • Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
    • Chronic pulmonary disease including asthma requiring regular use of medication
  6. Prior history of claustrophobia
  7. Metal implants
  8. Increased aneuploidy risk based on ultrasound findings or genetic testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749851


Contacts
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Contact: Women's Health Research Unit Confidential Recruitment Line 503-494-8748 PIP@ohsu.edu

Locations
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United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Women's Health Research Unit Confidential Recruitment Line    503-494-8748    PIP@ohsu.edu   
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Antonio Frias, MD Oregon Health and Science University

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Responsible Party: Antonio E. Frias, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02749851     History of Changes
Other Study ID Numbers: OHSU IRB 15196
U01HD087182 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Antonio E. Frias, Oregon Health and Science University:
pregnancy
growth restriction