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Completed

NCT Number: NCT02749851

Placenta Imaging Project

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.

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Key information

Conditions

Age range

18 year–52 year

Sex eligibility

Female

Study type

Observational

Primary location

Oregon Health and Science University, Portland, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

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:

  • 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

Inclusion criteria

for low risk group:

  • No history of a second or third trimester loss
  • No history of fetal growth restriction

Inclusion criteria

for high risk group:

  • 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

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.

  • 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)
  • Chronic pulmonary disease including asthma requiring regular use of medication
  • Prior history of claustrophobia
  • Metal implants
  • Increased aneuploidy risk based on ultrasound findings or genetic testing

Treatment and study plan

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.

Other names: magnetic resonance imaging

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.

Other names: magnetic resonance imaging

Primary outcomes

  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:

    • Fetal death (not due to genetic or infectious etiology),
    • Preeclampsia or gestational hypertension,
    • Small for gestational age fetus < 5%,
    • Oligohydramnios (defined as amniotic fluid index (AFI) < 5 cm) prompting delivery prior to 39 weeks gestation,
    • Abnormal fetal heart rate tracing prompting delivery prior to 39 weeks gestation,
    • Abnormal umbilical artery Doppler velocimetry prompting delivery prior to 39 weeks gestation.

Secondary outcomes

  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:

    • accelerated villous maturation
    • abnormal villous cytotrophoblast proliferation
    • microscopic infarctions
    • 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Functional Imaging of Human Placenta by MRI

Acronym: PIP

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2016
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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