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High Risk PregnancyPIPNCT02749851

Placenta Imaging Project

An observational study of High Risk Pregnancy, run by Oregon Health and Science University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 52 years, women onlyHealthy volunteers can take part
Conditions the study is for
High Risk Pregnancy
What is being tested?
MRI and MRI - IUGR
Type of treatment
Medical device
How many people
379 participants
Where
2 sitesUnited States
Study dates
13 Oct 2016to 30 Jun 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 52 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Functional Imaging of Human Placenta by MRI

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.

Read the 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.

Being tested
MRI, MRI - IUGR
Keywords
pregnancy, growth restriction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    Also called magnetic resonance imaging

    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.

  • MRI - IUGRDevice

    Also called magnetic resonance imaging

    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.

Study groups in NCT02749851
Study groupRoleWhat they receive
Non-smokersPregnant women that identify as non-smokers with low risk for placental insufficiency will receive the MRI Imaging intervention.
Receives: Device: MRI
SmokersPregnant women that identify as smokers will receive the MRI Imaging intervention.
Receives: Device: MRI
High risk/Non-SmokersPregnant 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.
Receives: Device: MRI
Confirmed IUGRPregnant women identified by their clinical care provided to have confirmed IUGR during their current pregnancy
Receives: Device: MRI - IUGR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from 16, 24, and 32 weeks gestation

  2. 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).

    Measured: Change from 16, 24, and 32 weeks gestation

  3. 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.

    Measured: 39 weeks gestation

Secondary outcomes (4)

  1. Composite of Placenta histologic outcomes

    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

    Measured: 39 weeks gestation

  2. Diagnosis of preeclampsia using standard clinical criteria

    Measured: 39 weeks gestation

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

    Measured: 39 weeks gestation

  4. Gestational age at delivery prior to 37 weeks gestation.

    Measured: 37 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2016 (estimated)
  2. Study start13 Oct 2016
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

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
Cohort
Time perspective
Prospective
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749851
Sponsor's protocol ID
OHSU IRB 15196
Other IDs
U01HD087182
Acronym
PIP
Status last verified
Oct 2020
First submitted
8 Feb 2016
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35853003

Questions about this trial

What is this clinical trial studying?

An observational study of High Risk Pregnancy, run by Oregon Health and Science University 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 20 inclusion and 0 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 5 Oct 2020. 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?

Placental perfusion (Units of measure: ml/min) measured at 3 time points across gestation. (time frame: Change from 16, 24, and 32 weeks gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02749851, which also lists 1 linked publication.

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 5 Oct 2020.

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