Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT03504969
Status:
UNKNOWN
Last Update Posted:
2018-04-20
First Post:
2018-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perinatal Outcomes in Umbilical Cord Entanglement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 201}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-04-19', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perinatal outcomes', 'timeFrame': 'one year', 'description': 'number of neonates with bad Apgar score'}], 'secondaryOutcomes': [{'measure': 'delivery outcome', 'timeFrame': 'one year', 'description': 'number of vaginal deliveries switch to S.C'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['umbilical cord'], 'conditions': ['Umbilical Cord; Complications, Affecting Fetus']}, 'descriptionModule': {'briefSummary': 'Umbilical Cord Entanglement and Perinatal Outcomes.', 'detailedDescription': 'Umbilical Cord Entanglement and Perinatal Outcomes neonatal outcomes and the effect on mode of delivery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women in active vaginal delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all vaginal deliveries with or without Umbilical Cord Entanglement\n\nExclusion Criteria:\n\n* multible pregnancy'}, 'identificationModule': {'nctId': 'NCT03504969', 'acronym': 'AssiutU', 'briefTitle': 'Perinatal Outcomes in Umbilical Cord Entanglement', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assiut University,Faculty of Medicine', 'orgStudyIdInfo': {'id': 'Assiut71515'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ghada Gamal', 'investigatorAffiliation': 'Assiut University'}}}}