Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-22 @ 9:55 AM
Study NCT ID:
NCT03782168
Status:
TERMINATED
Last Update Posted:
2024-09-03
First Post:
2018-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Concentration of Biological Markers in Placental Abruption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000037', 'term': 'Abruptio Placentae'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood for serum biomarkers and placental micro-particles.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'IRB approval expired; failure to submit continuing review in time. Will re-open once IRB approval is reinstated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the level of placental-derived MPs (Microparticles/mL)', 'timeFrame': 'Up to 75 minutes', 'description': 'Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PA compared to 10 matched control subjects.'}, {'measure': 'Identify biomarkers (picogram/mL) specifically, placental growth factor (PlGF), vascular endothelial growth factor (VEGF), soluble fms-like tyrosine kinase-1 (sFLT-1), and soluble endoglin (sEng)', 'timeFrame': 'Up to 75 minutes', 'description': 'Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PA compared to 10 matched control subjects.'}], 'secondaryOutcomes': [{'measure': 'Examine the correlation between maternal serum total placental MPs and biomarkers to clinical symptomology and the severity of placental abruption after delivery.', 'timeFrame': 'Up to 75 minutes', 'description': 'In order to evaluate the secondary outcome, the correlation between maternal serum total placental MPs, biomarkers to clinical symptomology, and the severity of placental abruption after delivery will be examined.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abruptio Placentae']}, 'descriptionModule': {'briefSummary': 'This will be a prospective study conducted on women with a suspected/confirmed diagnosis of placental abruption. Maternal blood samples will be taken at various points during the peripartum period. A healthy group of women admitted for delivery will act as a matched control and will have their blood sampled at similar time points. The primary outcome variables will include the total number of micro-particles, the number of micro-particles from each cell line (platelet, placental, endothelial etc.), and protein markers (specifically; placental growth factor (PlGF), soluble fms-like tyrosine kinase-1 (sFLT-1), vascular endothelial growth factor (VEGF), soluble endoglin (sEng)). Secondary outcomes if will examine the correlation between placental micro-particles, biomarkers, and extent of placental abruption.', 'detailedDescription': 'The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA. The knowledge gained from this study has the potential to develop a diagnostic test for PA with the ability to improve outcomes for mother and baby through earlier diagnosis and targeted therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mother-infant dyads with suspected or confirmed diagnosis of placental abruption and healthy mother-infant dyads admitted for delivery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - to 45-years old, inclusive\n* Suspected or confirmed PA or phenotypically matched controls\n* All modes of delivery\n* Gestational age greater than 28 weeks\n* Singleton pregnancy\n\nExclusion Criteria:\n\n* Intrauterine fetal demise,\n* Severe fetal anomalies (infant not expected to survive)\n* Inability to communicate in English'}, 'identificationModule': {'nctId': 'NCT03782168', 'briefTitle': 'Plasma Concentration of Biological Markers in Placental Abruption', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Plasma Concentration of Biological Markers in Placental Abruption', 'orgStudyIdInfo': {'id': '228485'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Placental Abruption', 'description': 'Mother-infant dyads with suspected or confirmed diagnosis of placental abruption', 'interventionNames': ['Other: There is no other intervention, only clinical treatment.']}, {'label': 'Phenotypically-matched controlled group', 'description': 'Healthy mother-infant dyads admitted for delivery', 'interventionNames': ['Other: There is no other intervention, only clinical treatment.']}], 'interventions': [{'name': 'There is no other intervention, only clinical treatment.', 'type': 'OTHER', 'description': 'The purpose of this study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with PA. The sensitivity and specificity of these proteins will be analyzed to further increase our understanding of the pathological mechanisms involved in PA.', 'armGroupLabels': ['Phenotypically-matched controlled group', 'Placental Abruption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Nadir Shawrawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}