Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-09 @ 4:12 PM
Study NCT ID:
NCT05837195
Status:
UNKNOWN
Last Update Posted:
2023-05-01
First Post:
2023-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diastolic Deceleration Area in Late-onset FGR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-19', 'studyFirstSubmitDate': '2023-04-19', 'studyFirstSubmitQcDate': '2023-04-19', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxia in the newborn', 'timeFrame': 'immediately after delivery', 'description': 'Defined by pH values \\< 7.20'}, {'measure': 'Anemia in the newborn', 'timeFrame': 'immediately after delivery', 'description': 'Hemoglobin deviation from GA mean - mild \\< 20 g/L, moderate - 20-70 g/L, severe \\> 70 g/L'}, {'measure': 'Occurence of hypoxic-ischemic encephalopathy', 'timeFrame': 'first 72 hours after delivery', 'description': 'Occurence of hypoxic-ischemic encephalopathy in relation to some of the outcome measures'}], 'secondaryOutcomes': [{'measure': 'Apgar score at 1st minute', 'timeFrame': '1 minute after delivery', 'description': 'Apgar score measured at 1st minute after delivery'}, {'measure': 'Apgar score at 5th minute', 'timeFrame': '5 minutes after delivery', 'description': 'Apgar score measured at 5th minute after delivery'}, {'measure': 'Apgar score at 10th minute', 'timeFrame': '10 minutes after delivery', 'description': 'Apgar score measured at 10th minute after delivery'}, {'measure': 'Admissions to a NICU', 'timeFrame': 'first 72 hours after delivery', 'description': 'Admissions to a NICU indicated by or related to some of the outcome measures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxia', 'Anemia']}, 'descriptionModule': {'briefSummary': 'DDA is a new Doppler parameter aiming to assess fetal well-being in-utero. Late-onset FGR is a specific subgroup of fetuses where the clinical application of this Doppler modality could play an essential role in detecting hypoxia, anemia, and other adverse neonatal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant subjects only', 'genderDescription': 'Pregnant subjects only', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* absence of fetal abnormalities and/or genetic conditions;\n* single pregnancy;\n* fetal growth restriction (FGR) \\< 10%, according to the INTERGROWTH 21st nomograms, appearing after 32nd week of gestation\n\nExclusion Criteria:\n\n* documented fetal abnormalities and/or genetic conditions in the course of the pregnancy;\n* multiple pregnancy;\n* absence of fetal growth restriction (FGR) \\< 10%, according to the INTERGROWTH 21st nomograms after 32nd week of gestation'}, 'identificationModule': {'nctId': 'NCT05837195', 'briefTitle': 'Diastolic Deceleration Area in Late-onset FGR', 'organization': {'class': 'OTHER', 'fullName': 'Orthogyn Medical Center, Bulgaria'}, 'officialTitle': 'Diastolic Deceleration Area (DDA) in Late-onset Fetal Growth Restriction (FGR)', 'orgStudyIdInfo': {'id': 'DDA2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Standard care:\n\nDoppler velocimetry: UA \\& MCA PI, DV PIV, CPR; Indirect cardiotocography (CTG) Biophysical profile (BPP)'}, {'label': 'DDA Doppler group', 'description': 'Standard care plus DDA Doppler monitoring', 'interventionNames': ['Device: DDA Doppler']}], 'interventions': [{'name': 'DDA Doppler', 'type': 'DEVICE', 'description': 'A new Doppler parameter to quantify the amount of vasodilatation in the middle cerebral artery (MCA) and other blood vessels.', 'armGroupLabels': ['DDA Doppler group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1606', 'city': 'Sofia', 'status': 'RECRUITING', 'country': 'Bulgaria', 'contacts': [{'name': 'Petar N Ignatov, PhD', 'role': 'CONTACT', 'email': 'ignatov@orthogyn.com', 'phone': '0888963189'}], 'facility': 'Orthogyn Medical and Dental Center', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'centralContacts': [{'name': 'Petar N Ignatov, PhD', 'role': 'CONTACT', 'email': 'ignatov@orthogyn.com', 'phone': '+359888963189'}], 'overallOfficials': [{'name': 'Petar N Ignatov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthogyn Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orthogyn Medical Center, Bulgaria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. prof. Petar Ignatov, M.D., Ph. D.', 'investigatorFullName': 'Petar Ignatov', 'investigatorAffiliation': 'Orthogyn Medical Center, Bulgaria'}}}}