Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-30 @ 12:40 PM
Study NCT ID:
NCT04525534
Status:
TERMINATED
Last Update Posted:
2024-09-03
First Post:
2020-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Concentration of Biological Markers in Placenta Accreta Spectrum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010921', 'term': 'Placenta Accreta'}, {'id': 'D010922', 'term': 'Placenta Diseases'}], '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'}]}}, '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': 19}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'difficulties with enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the level of placental-derived MPs (Microparticles/mL)', 'timeFrame': 'Up to 6 hours', 'description': 'Determine quantitatively the level of placental-derived MPs which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.'}, {'measure': 'Identify biomarkers (picogram/mL)', 'timeFrame': 'Up to 6 hours', 'description': 'Determine quantitatively the level of biomarkers which may be altered in 10 subjects with PAS and 10 phenotypically-matched controls.'}], 'secondaryOutcomes': [{'measure': 'Is there a correlation between maternal serum total placental MPs and biomarkers to the International Federation of Gynecology and Obstetrics (FIGO) classification for PAS at the time of cesarean delivery.', 'timeFrame': 'Up to 6 hours', 'description': 'Examine the correlation between maternal serum total placental MPs and biomarkers to the FIGO classification'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta', 'Placenta Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this exploratory study is to determine how well maternal serum biomarkers and placental micro-particles (MP) correlate with placenta accreta spectrum (PAS) at the time of cesarean delivery in women with suspected PAS compared to women without PAS. Our aim is to determine if women with PAS have a unique MP and protein signature at the time of delivery compared with women without PAS.', 'detailedDescription': 'Maternal blood samples will be taken at various points during the intrapartum 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 The knowledge gained from this study has the potential to develop a diagnostic test for PAS with the ability to improve management and outcomes for mother and baby through earlier diagnosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mother-infant dyads with suspected or confirmed diagnosis of PAS and healthy mother-infant dyads admitted for cesarean delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 - to 45-years old, inclusive\n* Suspected or confirmed PAS or phenotypically matched controls\n* Delivery by cesarean section\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* Emergent cesarean delivery'}, 'identificationModule': {'nctId': 'NCT04525534', 'briefTitle': 'Plasma Concentration of Biological Markers in Placenta Accreta Spectrum', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Plasma Concentration of Biological Markers in Placenta Spectrum', 'orgStudyIdInfo': {'id': '261299'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Placenta accreta spectrum', 'description': 'Mother-infant dyads with suspected or confirmed diagnosis of placenta accreta spectrum', 'interventionNames': ['Other: There is no other intervention, only clinical treatment.']}, {'label': 'Phenotypically-matched controlled group', 'description': 'Mother-infant dyads admitted for delivery without placenta accreta spectrum', 'interventionNames': ['Other: There is no other intervention, only clinical treatment.']}], 'interventions': [{'name': 'There is no other intervention, only clinical treatment.', 'type': 'OTHER', 'description': 'There is no other intervention, only clinical treatment', 'armGroupLabels': ['Phenotypically-matched controlled group', 'Placenta accreta spectrum']}]}, '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 e Sharawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UAMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}