Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-03-06 @ 8:00 AM
Study NCT ID:
NCT02749851
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2016-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placenta Imaging Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Specimens to be included:\n\nMaternal 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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-01', 'studyFirstSubmitDate': '2016-02-08', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Placental perfusion (Units of measure: ml/min) measured at 3 time points across gestation.', 'timeFrame': 'Change from 16, 24, and 32 weeks gestation', 'description': 'This will allow perfusion changes across pregnancy to be quantified in women from the three study groups.'}, {'measure': 'Optimal cutoff values of placental MRI for placenta mediated adverse outcomes using receiver operating characteristics (ROC)', 'timeFrame': 'Change from 16, 24, and 32 weeks gestation', 'description': '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).'}, {'measure': 'Composite of placenta-mediated adverse pregnancy outcomes', 'timeFrame': '39 weeks gestation', 'description': 'A binary variable indication whether the placenta-mediated adverse pregnancy has observed within 39 weeks gestation\n\nComposite of placenta-mediated adverse pregnancy outcomes defined as the presence of at least one of the following:\n\n1. Fetal death (not due to genetic or infectious etiology),\n2. Preeclampsia or gestational hypertension,\n3. Small for gestational age fetus \\< 5%,\n4. Oligohydramnios (defined as amniotic fluid index (AFI) \\< 5 cm) prompting delivery prior to 39 weeks gestation,\n5. Abnormal fetal heart rate tracing prompting delivery prior to 39 weeks gestation,\n6. Abnormal umbilical artery Doppler velocimetry prompting delivery prior to 39 weeks gestation.'}], 'secondaryOutcomes': [{'measure': 'Composite of Placenta histologic outcomes', 'timeFrame': '39 weeks gestation', 'description': 'Composite of placental histologic outcomes defined as the presence of one of the following:\n\n1. accelerated villous maturation\n2. abnormal villous cytotrophoblast proliferation\n3. microscopic infarctions\n4. decidual vasculopathy'}, {'measure': 'Diagnosis of preeclampsia using standard clinical criteria', 'timeFrame': '39 weeks gestation'}, {'measure': 'Small for gestational age fetus at 3% and 5%', 'timeFrame': '39 weeks gestation'}, {'measure': 'Gestational age at delivery prior to 37 weeks gestation.', 'timeFrame': '37 weeks gestation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pregnancy', 'growth restriction'], 'conditions': ['High Risk Pregnancy']}, 'referencesModule': {'references': [{'pmid': '35853003', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis study will help provide information about:\n\n* How the placenta grows and develops during pregnancy\n* How the placenta delivers nutrients, like oxygen to the developing fetus\n* If placental function using new advanced imaging tools can predict pregnancy complications like fetal growth restriction, stillbirth, preeclampsia and preterm labor\n\nThis 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.\n\nAdditionally 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '52 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who plan to deliver at OHSU or University of Utah hospitals and live within the areas served by those medical facilities.', 'healthyVolunteers': True, 'eligibilityCriteria': "Pregnant women will be recruited based on inclusion criteria for 3 subject groups:\n\n1. Non-smokers with low risk for placental insufficiency\n2. Smokers\n3. Non-smokers who are at a high risk for adverse outcomes based on prior clinical history.\n\nInclusion criteria: Pregnant women fulfilling inclusion criteria, and not meeting exclusion criteria, will be invited to participate in this study.\n\nInclusion criteria for all groups:\n\n1. Maternal age over 18 years and able to give informed consent\n2. 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\n\nInclusion criteria for low risk group:\n\n1. No history of a second or third trimester loss\n2. No history of fetal growth restriction\n\nInclusion criteria for high risk group:\n\n1. 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\n2. Not currently a smoker\n3. Pregnancy at risk for placental insufficiency due to clinical concerns (eg. chronic hypertension)\n4. Spontaneous preterm birth \\<34 weeks\n\nExclusion criteria: These criteria will exclude women whose medications, personality traits or obstetric conditions could confound their ability to complete a 1 hour MRI scan.\n\n1. Individuals with intellectual disability or who are incarcerated\n2. Multiple gestation\n3. Major fetal anomalies known to be associated with abnormal growth (i.e. major congenital heart defect, gastroschisis)\n4. Current maternal history of alcohol or illicit drug use\n5. Current medical problems requiring chronic treatment:\n\n * Cancer\n * Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)\n * Chronic pulmonary disease including asthma requiring regular use of medication\n6. Prior history of claustrophobia\n7. Metal implants\n8. Increased aneuploidy risk based on ultrasound findings or genetic testing"}, 'identificationModule': {'nctId': 'NCT02749851', 'acronym': 'PIP', 'briefTitle': 'Placenta Imaging Project', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Functional Imaging of Human Placenta by MRI', 'orgStudyIdInfo': {'id': 'OHSU IRB 15196'}, 'secondaryIdInfos': [{'id': 'U01HD087182', 'link': 'https://reporter.nih.gov/quickSearch/U01HD087182', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-smokers', 'description': 'Pregnant women that identify as non-smokers with low risk for placental insufficiency will receive the MRI Imaging intervention.', 'interventionNames': ['Device: MRI']}, {'label': 'Smokers', 'description': 'Pregnant women that identify as smokers will receive the MRI Imaging intervention.', 'interventionNames': ['Device: MRI']}, {'label': 'High risk/Non-Smokers', 'description': '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.', 'interventionNames': ['Device: MRI']}, {'label': 'Confirmed IUGR', 'description': 'Pregnant women identified by their clinical care provided to have confirmed IUGR during their current pregnancy', 'interventionNames': ['Device: MRI - IUGR']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'otherNames': ['magnetic resonance imaging'], 'description': '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.', 'armGroupLabels': ['High risk/Non-Smokers', 'Non-smokers', 'Smokers']}, {'name': 'MRI - IUGR', 'type': 'DEVICE', 'otherNames': ['magnetic resonance imaging'], 'description': '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.', 'armGroupLabels': ['Confirmed IUGR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Antonio Frias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Antonio E. Frias', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}