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| ID | Type | Description | Link |
|---|---|---|---|
| U01HD087182 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-smokers | Pregnant women that identify as non-smokers with low risk for placental insufficiency will receive the MRI Imaging intervention. |
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| Smokers | Pregnant women that identify as smokers will receive the MRI Imaging intervention. |
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| 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. |
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| Confirmed IUGR | Pregnant women identified by their clinical care provided to have confirmed IUGR during their current pregnancy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 39 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Placenta histologic outcomes | Composite of placental histologic outcomes defined as the presence of one of the following:
| 39 weeks gestation |
| Diagnosis of preeclampsia using standard clinical criteria |
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Pregnant women will be recruited based on inclusion criteria for 3 subject groups:
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:
Inclusion criteria for low risk group:
Inclusion criteria for high risk group:
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:
Prior history of claustrophobia
Metal implants
Increased aneuploidy risk based on ultrasound findings or genetic testing
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Women who plan to deliver at OHSU or University of Utah hospitals and live within the areas served by those medical facilities.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Frias, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States | ||
| University of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35853003 | Derived | 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. |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| 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. |
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| 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 |
| Salt Lake City |
| Utah |
| 84112 |
| United States |