Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT03983902
Status:
UNKNOWN
Last Update Posted:
2019-06-14
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placental Transfusion Methods and Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005330', 'term': 'Fetofetal Transfusion'}], 'ancestors': [{'id': 'D000751', 'term': 'Anemia, Neonatal'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087526', 'term': 'Umbilical Cord Clamping'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2019-06-10', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The levels of stem cells', 'timeFrame': '18-months', 'description': 'Measurement of the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells'}], 'secondaryOutcomes': [{'measure': 'Placental residual volume', 'timeFrame': '18-months', 'description': 'The placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stem cell', 'newborn', 'endothelial progenitor cell', 'CD34+ hematopoietic stem cell', 'delayed cord clamping', 'umbilical cord milking', 'immediate cord clamping'], 'conditions': ['Placental Transfusion', 'Stem Cells']}, 'descriptionModule': {'briefSummary': 'To measure the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells levels, and placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping in newborns at different gestational weeks.', 'detailedDescription': 'Umbilical cord blood is a rich source of stem cells. Placental transfusion is the transfer of the placental blood to the baby until the cord clamped during the birth. Placental transfusion can be accomplished by delayed cord clamping or umbilical cord milking.\n\nOne group will receive 2 minutes of delayed cord clamping, the second group will receive umbilical cord milking and the third group will receive immediate cord clamping. Following the cord clamping, the blood samples will be taken from the placental site of the umbilical cord to measure the stem cells from all subjects and placental residual volume will be measured.\n\nDelivery room conditions, hospitalization (if needed), short-term outcome during hospitalization, prematurity related morbidities (if baby is preterm) will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBorn at 24 weeks to 42 weeks infants\n\nExclusion Criteria:\n\nWithout parental consent, known congenital anomalies'}, 'identificationModule': {'nctId': 'NCT03983902', 'briefTitle': 'Placental Transfusion Methods and Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'The Effect of Placental Transfusion Methods on the Potentially Transfusion Levels of Endothelial Progenitor Cell and CD34+ Hematopoietic Stem Cell', 'orgStudyIdInfo': {'id': 'Ankara University-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed cord clamping', 'description': 'Delayed cord clamping', 'interventionNames': ['Procedure: Delayed cord clamping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Umbilical cord milking', 'description': 'Umbilical cord clamping', 'interventionNames': ['Procedure: Umbilical cord milking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate cord clamping', 'description': 'Immediate cord clamping', 'interventionNames': ['Procedure: Immediate cord clamping']}], 'interventions': [{'name': 'Delayed cord clamping', 'type': 'PROCEDURE', 'description': 'Delayed cord clamping will occur for up to 2 minutes.', 'armGroupLabels': ['Delayed cord clamping']}, {'name': 'Umbilical cord milking', 'type': 'PROCEDURE', 'description': 'Umbilical cord milking will occur milking of the 30 cm of the cord from placental site to baby, at a speed of 5 cm/second, 3 times in preterm newborns, 4 times in term newborns.', 'armGroupLabels': ['Umbilical cord milking']}, {'name': 'Immediate cord clamping', 'type': 'PROCEDURE', 'description': 'Immediate cord clamping will occur in 20 seconds after birth.', 'armGroupLabels': ['Immediate cord clamping']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emel Okulu, MD', 'role': 'CONTACT', 'email': 'emelokulu@gmail.com', 'phone': '+90-312-595000', 'phoneExt': '6599'}, {'name': 'Saadet Arsan, MD', 'role': 'CONTACT', 'email': 'Saadet.Arsan@medicine.ankara.edu.tr', 'phone': '+90-312-595000', 'phoneExt': '6324'}], 'overallOfficials': [{'name': 'Emel Okulu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emel Okulu,MD', 'investigatorAffiliation': 'Ankara University'}}}}